[Federal Register Volume 62, Number 232 (Wednesday, December 3, 1997)]
[Notices]
[Pages 64074-64100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 97-31741]



[[Page 64073]]

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Part III





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



Final Guidance on Industry-Supported Scientific and Educational 
Activities; Notice

Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / 
Notices

[[Page 64074]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 92N-0434]


Final Guidance on Industry-Supported Scientific and Educational 
Activities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a final 
guidance entitled ``Final Guidance on Industry-Supported Scientific and 
Educational Activities'' (hereinafter referred to as the final 
guidance). The agency sought public comment on a draft version of this 
final guidance entitled ``Draft Policy Statement on Industry-Supported 
Scientific and Educational Activities'' (hereinafter referred to as the 
draft policy statement), which was published in the Federal Register on 
November 27, 1992; and on November 18, 1994, on a related citizen 
petition. The agency considered the comments received and, where 
appropriate, revised the draft policy statement to create the final 
guidance. The final guidance describes how industry may support 
scientific and educational activities without being subject to 
regulation under the Federal Food, Drug, and Cosmetic Act (the act). 
The full text of the guidance is published in this document.

DATES: Written comments on the guidance may be submitted at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: 
    For general questions about the guidance: Ilisa B. G. Bernstein, 
Office of Policy (HF-23), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-3380, or via e-mail at 
IBernste@oc.fda.gov;
    Regarding biological products: Toni M. Stifano, Center for 
Biologics Evaluation and Research (HFM-200), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or via e-mail at stifano@cber.fda.gov;
    Regarding medical device products: Byron L. Tart, Center for Device 
Evaluation and Radiologic Health (HFZ-302), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4639, or 
via e-mail at bxt@cdrh.fda.gov;
    Regarding human prescription drugs: Norman A. Drezin, Center for 
Drug Evaluation and Research (HFD-40), Food and Drug Administration, 
5600 Fishers Lane, rm. 17B-17, Rockville, MD 20857, 301-827-2831, or 
via e-mail at drezinn@cder.fda.gov;
    Regarding prescription animal drugs: Edward L. Spenser, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1722, or via e-mail at 
espenser@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 27, 1992 
(57 FR 56412), FDA published the draft policy statement. As the agency 
noted in the introduction to the draft policy statement, these 
activities may be subject to regulation under the labeling and 
advertising provisions of the act when they provide information on FDA-
regulated products marketed by the supporting companies.
    As the introduction also noted, FDA traditionally has not sought to 
regulate industry-supported scientific and educational activities that 
are otherwise independent and nonpromotional. Industry-supported 
scientific and educational activities that are not independent and 
nonpromotional are not per se illegal, but they are subject to 
regulation.
    FDA published the draft policy statement in response to requests 
from industry for guidance in this area. Prior to publishing the draft 
policy statement, the agency engaged in an extensive outreach effort 
with scientific and health care professionals, industry, consumer 
groups, and other Government agencies in an attempt to strike a proper 
balance between the need for industry-supported dissemination of 
current scientific information and the need to ensure that promotional 
activities by industry meet the requirements of the law.
    Recognizing the importance and delicacy of this balance, the agency 
invited comments with regard to all issues raised in the draft policy 
statement.
    The agency received 152 comments, which included comments from 
academic and organized medicine, health care professionals, industry 
and trade associations, public relations and advertising firms, and 
commercial continuing education providers. FDA thoroughly considered 
these comments and revised the draft policy statement where 
appropriate. In the Federal Register of November 18, 1994 (59 FR 
59820), the agency sought comment on a citizen petition (Docket No. 
92N-0434/CP1) requesting that the agency withdraw the draft policy 
statement. The agency received about 60 comments in response to this 
notice.

I. Highlights of the Final Guidance

    In response to comments, the agency has made several revisions to 
the draft policy statement. First, the draft policy statement has been 
modified to clarify that it is providing guidance on what the agency 
would look at in determining independence. In doing so, rather than 
enumerating the elements of a written agreement, the final guidance 
presents the ideas contained in the elements as factors the agency will 
consider in evaluating activities and determining independence. 
Additionally, the text of ``Other Factors in Determining Independence'' 
indicia that were listed in section II.B. of the draft policy statement 
(57 FR 56412 at 56414) are now included in the factors the agency will 
consider in evaluating activities and determining independence. Second, 
although the final guidance has been modified to place less emphasis on 
a written agreement between the supporting company and the provider, 
the agency continues to believe that a written agreement is one way to 
document what measures were taken by the parties to maintain the 
independence of the program.
    In the final guidance, only 1 of the 10 elements of the written 
agreement presented in the draft policy statement remains unchanged. 
The ``Statement of Purpose'' (section II.A.1. of the draft policy 
statement) has been deleted because the final guidance lists the 
factors the agency will consider, rather than a suggested written 
agreement. The text of the ``Control of Content and Selection of 
Presenters and Moderators'' (section II.A.2. of the draft policy 
statement) has been modified slightly, but remains substantially 
unchanged. In the ``Disclosure of Financial Relationships'' (section 
II.A.3. of the draft policy statement) a factor has been added 
indicating that when an activity includes discussion of unapproved 
uses, there should be general disclosure of that fact. Additionally 
this discussion has been renamed ``Disclosures,'' and all factors that 
describe a disclosure are listed under this heading. The discussion 
concerning ``Supporting Company Involvement in Content'' (section 
II.A.4. of the draft policy statement) has been incorporated into the 
factor concerning ``Control of Content and Selection of Presenters and 
Moderators'' of the final guidance. The

[[Page 64075]]

discussion of ``Ancillary Promotional Activities'' (section II.A.5. of 
the draft policy statement) has been narrowed so as to limit 
promotional activities only in the room in which an activity takes 
place. The discussions concerning ``Objectivity and Balance'' (section 
II.A.6.), ``Limitations on Data'' (section II.A.7. of the draft policy 
statement), and ``Discussion of Unapproved Uses'' (section II.A.8. of 
the draft policy statement) have been deleted from the final guidance. 
The ``Opportunities for Debate'' (section II.A.9. of the draft policy 
statement) has been renamed ``Opportunities for Discussion'' to clarify 
its intent. The ``Schedule of Activities'' discussion (section II.A.10. 
of the draft policy statement) has also been deleted from the final 
guidance.
    Much of the draft policy statement's section entitled ``Other 
Factors in Determining Independence'' appears in the final guidance, 
with a few modifications. First, the discussions concerning the 
``Provider'' (section II.B.1. of the draft policy statement) has been 
modified slightly, deleting the statement that discussed whether 
persons who are involved in promotion of a company's products may 
function in the role as an independent provider. The discussion 
concerning industry representatives help in logistical assistance 
(section II.B.2.a. of the draft policy statement) has been deleted from 
final guidance. The ``Suggestion of Presenters'' discussion (section 
II.B.2.b. of the draft policy statement) has been incorporated, in 
part, into the factor concerning ``Control and Content and Selection of 
Presenters and Moderators'' in the final guidance. The discussion 
concerning ``Focus on a Single Product'' (section II.B.3.a. of the 
draft policy statement) has been incorporated into the factor entitled 
``Focus of the Program'' in the final guidance. The discussions 
concerning ``Multiple Performances'' (section II.B.3.b. of the draft 
policy statement), ``Audience Selection'' (section II.B.4.c.), 
``Dissemination'' (section II.B.5.), and ``Complaints'' (section 
II.B.6.) remain substantially unchanged. The ``Gifts'' (section 
II.B.4.a.) and ``Emphasis on Noneducational Activities'' (section 
II.B.4.b.) discussions have been deleted from the final guidance. 
Finally, the discussion concerning ``Misleading Title'' (section 
II.B.4.d. of the draft policy statement) has been incorporated into the 
factor concerning ``Focus of the Program'' in the final guidance.
    In general, these revisions are intended to better focus the final 
guidance on the agency's core concerns--that the provider develop the 
subject program independent from the influence of the supporting 
company, and that there is disclosure of relationships between and 
among the supporting company, provider, presenters, and products 
discussed that may be relevant to an assessment of the information 
presented. Thus, while the number of changes may be significant, they 
do not change the fundamental intent of the final guidance to 
distinguish industry-supported scientific and educational activities 
that are free from supporting company influence from those that are 
not.

II. Summary and Responses to Comments Received

A. General Comments

    1. Several comments disputed the agency's assertion that industry-
supported scientific and educational activities traditionally have been 
viewed by the agency as subject to regulation under the act. They 
maintained that regulation of these activities is an unwarranted 
expansion of agency authority and that the agency should specifically 
articulate the basis for its regulatory authority.
    FDA has long regulated drugs and devices (including biological 
products and animal drugs) based on the ``intended uses'' for such 
products. Under section 201 of the act (21 U.S.C. 321), which defines 
the terms ``drug'' and ``device,'' the intended use of an article 
determines whether the article is a drug or device. In general, under 
the act and the Public Health Service Act, a sponsor who wishes to 
market any new drug or biological product must demonstrate to FDA that 
the product is safe and effective for each of its intended uses. (See 
sections 505(a) and 512(a) of the act (21 U.S.C. 355(a) and 360b(a)) 
and section 351 of the Public Health Service Act.) A sponsor who wishes 
to market a new medical device must either demonstrate to FDA that 
there is a reasonable assurance that the device is safe and effective 
for each of its intended uses or that it is substantially equivalent to 
(meaning, in part, that it has the same intended use as) another device 
for which such a showing is not required. (See sections 510(k), 513(f) 
and (i), and 515(a) of the act (21 U.S.C. 360(k), 360c(f) and (i), and 
360e(a)).) The package insert or product manual (approved professional 
labeling) which, for approved and/or licensed products, physically 
accompanies the product, sets forth the uses for which the product has 
been demonstrated to be safe and effective.
    The ``intended use'' of a drug or device refers to the objective 
intent of the persons legally responsible for the labeling of the 
product. This intent is determined by such persons' expressions or by 
the circumstances surrounding the distribution of the article 
including, for example, labeling claims, advertising matter, or oral or 
written statements by such persons or their representatives. (See 21 
CFR 201.128 and 801.4.) The agency, thus, regulates products based not 
only on information provided ``with'' the product (approved 
professional labeling), but also based on information disseminated by 
or on behalf of manufacturers in other contexts, such as scientific and 
educational meetings and symposia, books, reprints of articles from 
scientific journals, in part because all of these activities/materials 
can create new intended uses for the products, which must be reflected 
in the approved labeling of the products.
    The agency's focus on the manufacturer's characterization of its 
product in the marketplace is best reflected in the statutory 
requirement that a drug or device shall be deemed to be misbranded 
unless its labeling bears adequate directions for use. (See section 
502(f)(1) of the act (21 U.S.C. 352(f)(1)).) The courts have agreed 
with the agency that section 502(f)(1) of the act requires information 
not only on how a product is to be used (e.g., dosage and 
administration), but also on all the intended uses of the product. (See 
Alberty Food Products Co. v. United States, 185 F.2d 321 (9th Cir. 
1950) (drug product was misbranded because its labeling failed to state 
the intended use of the drug (arthritis and rheumatism) as suggested by 
the company in newspaper advertisements); 21 CFR 201.5)) As previously 
described, oral statements and materials presented at industry-
supported scientific and educational activities may provide evidence of 
a product's intended use. If these statements or materials promote a 
use that is inconsistent with the product's approved labeling, the 
product is misbranded under section 502(f)(1) of the act for failure to 
bear labeling with adequate directions for all intended uses. If it is 
a device, it is also adulterated because the listing of unapproved uses 
in the labeling or advertising of an approved device results in an 
adulterated medical device under section 501(f) of the act, and 
misbranded under section 502(o) of the act because premarket 
notification was not provided as required under section 510(k) of the 
act.
    FDA also finds support for its policy of examining a broad array of 
information disseminated by companies in the general grant of authority 
over labeling and advertisements. Section

[[Page 64076]]

201(m) of the act defines the term ``labeling'' to include all 
``written, printed, or graphic'' materials ``accompanying'' a regulated 
product. The Supreme Court has agreed with the agency that this 
definition is not limited to materials that physically accompany a 
product. If the material supplements, explains, or is otherwise 
textually related to a product, it is deemed to accompany the product 
for purposes of section 201(m) of the act. (See Kordel v. United 
States, 335 U.S. 345 (1948).)
    The agency has adopted a similar interpretation of the term 
``advertisement,'' which appears in section 502(n) of the act 
(prescription drug advertisements) and 502(r) of the act (restricted 
device advertisements). Although the act does not define the term 
``advertisement,'' section 502(n) and (r) of the act indicates that 
advertisements do not include materials regulated as labeling. In 
addition, the legislative histories of the 1938 act and the 1962 
amendments to the act support a broad construction of what constitutes 
``advertising.'' Thus, the agency interprets the term ``advertisement'' 
to include information (other than labeling) that originates from the 
same source as the product and that is intended to supplement or 
explain the product. Prescription drug and restricted device 
advertisements that do not comply with section 502(n), (q), or (r) of 
the act, or regulations issued thereunder, cause a prescription drug or 
restricted device to be misbranded.
    2. Some comments contended that the policy will adversely affect 
the availability and quality of continuing education for health care 
professionals. They maintained that the perception of regulatory risk 
on the part of supporting companies, as well as administrative and 
financial burdens resulting from compliance with the policy, will cause 
companies that have supported educational programs to redirect funds to 
lower risk, more efficient activities.
    The agency recognizes the importance of continuing education for 
health care professionals and recognizes, as well, the traditional role 
of industry in supporting such activities. With this final guidance, 
the agency has attempted to address concerns raised by supporting 
companies, to describe factors the agency will consider in determining 
whether an industry-supported activity is independent and not generally 
subject to regulation, and to accommodate industry's need for 
predictability in these activities. The agency believes that the 
flexibility accorded companies in the final guidance and in the 
agency's responses to these comments should provide a reasonable basis 
for continued support for these activities. Decisions by companies 
involving allocation of resources for promotion and education are, of 
course, affected by a variety of factors. The agency cannot ensure that 
companies will provide a given level of support for professional 
education within the health care community.

B. The First Amendment

    3. Several comments contended that the Draft Policy Statement on 
Industry-Supported Scientific and Educational Activities (Draft Policy 
Statement) infringes upon the First Amendment to the Constitution. Some 
comments claimed that the Draft Policy Statement infringed protections 
afforded to commercial speech.
    The agency has considered the First Amendment in developing its 
policies on industry-supported scientific and educational activities, 
and believes that the Draft Policy Statement and the Final Guidance are 
consistent with the First Amendment's protection of freedom of 
expression. In producing these policy statements (guidance), FDA has 
sought to accommodate the need for industry-supported scientific and 
educational activities and the statutory mandate to regulate 
promotional activities (labeling and advertising) for drugs and devices 
in accordance with the act and the Public Health Service Act.
1. The Regulation of Drugs and Devices
    FDA's guidance on industry-supported scientific and educational 
activities describes the agency's regulation of drugs and medical 
devices; it is not intended to regulate speech. It provides insight 
into the factors FDA will consider when evaluating an industry-
supported activity to determine whether it should be subject to 
regulation as labeling or advertising, and, if so, to ensure that the 
activity does not misbrand or adulterate the subject drug or device. 
There are three bases for this conclusion.
    First, the guidance applies only to those company-supported 
activities that relate to the supporting company's product(s) or to 
competing product(s). A company-supported activity that does not relate 
to the company's product, a competing product, or suggest a use for the 
company's product would not be subject to regulation as a promotional 
activity.
    Second, the guidance distinguishes between company-supported 
activities that are independent of the promotional influence of the 
supporting company and those that are not. As explained in the 
guidance, the agency does not seek to regulate industry-supported 
activities that are independent and nonpromotional.
    Third, the regulation of drugs and devices has an unavoidable 
effect on speech. As explained more fully in response to Comment A.1, 
the act mandates that FDA regulate products as drugs or devices 
(including biological products and animal drugs) based on the 
``intended uses'' for such products.
    Under section 201 of the act which defines, among other things, the 
terms ``drug'' and ``device,'' the intended use of an article 
determines whether the article is a drug or device. In general, under 
the act and the Public Health Service Act, a sponsor who wishes to 
market any new drug or biological product must demonstrate to FDA that 
the product is safe and effective for each of its intended uses 
(sections 505(a) and 512(a) of the act and section 351 of the Public 
Health Service Act). A sponsor who wishes to market a new medical 
device must either demonstrate to FDA that there is a reasonable 
assurance that the device is safe and effective for each of its 
intended uses or that it is substantially equivalent to (meaning, in 
part, that it has the same intended use as) another device for which 
such a showing is not required (sections 510(k), 513(f) and (i), and 
515(a) of the act). In addition, all drugs and devices must bear 
labeling with adequate directions for each intended use. If labeling 
for a drug or device fails to contain adequate directions for each 
intended use, the drug or device is deemed to be misbranded (section 
502(f)(1) of the act) and subject to seizure or other enforcement 
actions. For approved or licensed products, the requirement that 
products bear labeling with adequate directions for use is met by 
inclusion of the products' FDA-approved professional labeling (package 
insert or product manual) that sets forth the uses for which the 
product has been approved/cleared as safe and effective.
    The intended use of a drug or device refers to the objective intent 
of the persons legally responsible for the labeling of the product.
    The intent is determined by such persons' expressions or may be 
shown by the circumstances surrounding the distribution of the 
article. This objective intent may, for example, be shown by 
labeling claims, advertising matter, or oral or written statements 
by such persons or their representatives.
(21 CFR 201.128 and 801.4) (emphasis added); see e.g., Coyne Beahm, 
Inc., et al. v. United States Food and Drug Administration, et al., 958 
F. Supp. 1060 (M.D.N.C. 1997).
    Accordingly, oral statements and materials presented at industry-

[[Page 64077]]

supported scientific and educational activities may provide evidence of 
a product's intended use. If these statements or materials promote a 
use that has not been approved by the agency (and therefore does not 
appear in the product's approved labeling), the product is misbranded 
under section 502(f)(1) of the Act for failure to bear labeling with 
adequate directions for all intended uses (21 CFR 201.5; Alberty Food 
Products Co. v. United States, 185 F.2d 321 (9th Cir. 1950)). The 
product may also be misbranded if its labeling\1\ or advertising is 
false or misleading (section 502(a), (n), and (q) of the act). If it is 
a device, it is also adulterated because the listing of unapproved uses 
in the labeling or advertising of an approved device results in an 
adulterated medical device under section 501(f) of the act, and 
misbranded under section 502(o) of the act because premarket 
notification was not provided as required under section 510(k) of the 
act.\2\ Thus, FDA's regulation of intended uses for drugs and devices 
is essential to the regulation of such products. The safety and 
effectiveness of drugs and devices cannot be evaluated in isolation 
from consideration of their intended uses.
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    \1\ Section 201(m) of the act defines the term ``labeling'' to 
include all ``written, printed, or graphic'' materials 
``accompanying'' a regulated product. (See Kordel v. United States, 
335 U.S. 345, 349-350 (1948).)
    \2\ It is a violation of the act to, among other things, 
introduce or deliver for introduction into interstate commerce a 
misbranded or adulterated drug or device, or to cause the 
misbranding or adulteration of a drug or device while it is held for 
sale after shipment in interstate commerce. (See e.g., sections 
301(a) and (k) of the act.)
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    The Supreme Court ``has recognized the strong governmental interest 
in certain forms of economic regulation, even though such regulation 
may have an incidental effect on rights of speech * * *'' (NAACP v. 
Claiborne Hardware Co., 102 S.Ct. 3409, 3425 (1982)). (See also Ohralik 
v. Ohio State Bar Association, 98 S.Ct. 1912, 1919 (1978) (the 
government ``does not lose its power to regulate commercial activity 
deemed harmful to the public whenever speech is a component of that 
activity'').) Similarly, several lower courts have recognized that in 
certain areas of extensive Federal regulation (securities, antitrust, 
transportation, trade, and labor), the Government may regulate 
communications of the regulated parties without offending the First 
Amendment. In particular, SEC v. Wall Street Publishing Institute, 
Inc., 851 F.2d 365 (D.C. Cir. 1988), cert. denied, 109 S.Ct. 1342 
(1989), is most analogous to FDA's regulation of industry-supported 
scientific and educational activities.
    The defendant in Wall Street Publishing published a stock market 
magazine that included feature articles profiling individual companies 
and portraying the subject firms as appealing investment prospects. 
Some of the articles were written by the featured company itself, 
others were written by public relations firms paid by the featured 
companies, and still others were written by the editors of the 
magazine, who were paid by the featured companies. Because these 
arrangements were not disclosed in the magazine, the Securities 
Exchange Commission (SEC) sought to enjoin the publisher for violations 
of section 17(b) of the Securities Act of 1993, 15 U.S.C. 77q(b), which 
makes it unlawful to describe a security for consideration without 
disclosing the existence of the consideration. The publisher challenged 
the injunction on, among others, First Amendment grounds.
    The court rejected the SEC's characterization of the feature 
articles as commercial speech and upheld the government's efforts to 
regulate the magazine based on ``the federal government's broad powers 
to regulate the security industry'' (Id. at 372 (footnote omitted)). 
According to the court, ``[w]here the federal government extensively 
regulates a field of economic activity, communication of the regulated 
parties often bears directly on the particular economic objectives 
sought by the government, and regulation of such communications has 
been upheld'' (Id. (citations omitted)). This holding stems from the 
fact that ``[i]f speech employed directly or indirectly to sell 
securities were totally protected, any regulation of the securities 
market would be infeasible* * *.'' (Id. at 373; see also Id. at 374 n.9 
(``Requiring disclosure of a material fact in order to prevent investor 
misunderstanding is the very essence of federal securities 
regulation.''))
    The court noted that:
    [R]egulation of the exchange of information regarding securities 
is subject only to limited First Amendment scrutiny. Speech relating 
to the purchase and sale of securities, in our view, forms a 
distinct category of communications in which the government's power 
to regulate is at least as broad as with respect to the general 
rubric of commercial speech * * * In areas of extensive federal 
regulation * * * we do not believe the Constitution requires the 
judiciary to weigh the relative merits of particular regulatory 
objectives that impinge upon communications occurring within the 
umbrella of an overall regulatory scheme.
Id. at 373. See also Home Box Office, Inc. v. FCC, 567 F.2d 9, 46 (D.C. 
Cir. 1977), cert. denied, 434 U.S. 829 (1977) (``[R]ules restricting 
speech do not necessarily abridge freedom of speech.''); SEC v. Suter, 
732 F.2d 1294 (7th Cir. 1984).
    As with securities regulation, the Federal Government exerts 
extensive authority over the sale and promotion of drugs and devices. 
Moreover, as previously explained, the Government's ability to regulate 
speech about these products, like its need to regulate speech 
concerning the sale of securities, is essential to the regulation of 
drugs and devices. Yet the regulation of drugs and devices, unlike the 
regulation of securities, clearly encompasses more than economic 
activity; it protects consumer health and safety in an area where harm 
to the public can be direct and immediate.
    Accordingly, First Amendment defenses have been raised and rejected 
in a number of FDA enforcement actions. ``Freedom of speech does not 
include the freedom to violate the labeling provisions of the Federal 
Food, Drug, and Cosmetic Act'' (United States v. Articles of Food * * * 
Clover Club Potato Chips, 67 F.R.D. 419, 424 (D. Idaho 1975)). The 
First Amendment does not prohibit the seizure and condemnation of a 
book that is used to misbrand a product (United States v. 8 Cartons, 
Containing ``Plantation 'The Original' etc. Molasses'', 103 F. Supp. 
626, 628 (W.D.N.Y. 1951); United States v. Articles of Drug, 32 F.R.D. 
32, 35 (S.D. Ill. 1963); but cf. United States v. 24 Bottles * * 
*''Sterling Vinegar and Honey'', 338 F.2d 157 (2d Cir. 1964) (book not 
used in immediate connection with sale of product is not labeling and 
does not misbrand product)).
    In conclusion, the act requires that FDA regulate drugs and devices 
based on their ``intended use.'' The term ``intended use'' is broadly 
defined to capture the manner in which a company characterizes its 
product in the marketplace. The agency thus must examine the various 
means by which manufacturers and their representatives provide 
information about their products to health care professionals and 
consumers, including statements and materials presented at industry-
supported scientific and educational activities, to determine whether 
the products are being improperly promoted, and therefore misbranded or 
adulterated. Accordingly, FDA's ability to regulate the communications 
at such activities is essential to the regulation of drugs and devices. 
In view of the fact that the regulation of drugs and devices is an area 
of extensive federal regulation, the agency may regulate the 
communications at industry-supported

[[Page 64078]]

scientific and educational activities without violating the First 
Amendment.
2. Commercial Speech
    Assuming, contrary to the analysis just presented, that industry-
supported scientific and educational activities constitute protected 
speech, they are commercial speech and FDA's regulation of such 
activities does not violate the First Amendment. Although the Supreme 
Court has furnished little explicit guidance as to how to determine 
whether speech is commercial, it has provided some suggestion as to 
what factors are relevant when making a commercial speech 
determination. (See Bolger v. Youngs Drug Products), 103 S.Ct. 2875 
(1983) (concluding that informational pamphlets are commercial speech 
based on a combination of three characteristics (conceded to be 
advertisements, reference to a specific product, and economic 
motivation), but not suggesting that each of these characteristics is a 
necessary element of commercial speech); S.U.N.Y. v. Fox, 109 S.Ct. 
3028 (1989) (speech which proposes a commercial transaction); 
Cincinnati v. Discovery Network, 113 S.Ct. 1505 (1993) (speech which 
proposes a commercial transaction).) Furthermore, the Court has made 
clear that speech which does more than propose a commercial transaction 
(linking a product to a current public debate or containing discussions 
of important public issues) is not necessarily transformed into 
noncommercial speech (Central Hudson Gas & Electric Corp. v. Public 
Serv. Comm'n, 100 S.Ct. 2343 (1980); Bolger, 103 S.Ct. at 2880-2881).
    Applying the characteristics suggested in Bolger (advertisement, 
reference to a specific product, economic motivation) or the test used 
in Fox and Discovery Network (speech which proposes a commercial 
transaction), industry-supported scientific and educational activities 
are commercial speech. The guidance at issue only applies to activities 
that make reference to a specific product, and as explained below, the 
activities are economically motivated and propose a commercial 
transaction. Drug and device companies sponsor such programs not only 
to encourage scientific exchange, education, and corporate goodwill, 
but more importantly, to convince the audience to prescribe, purchase, 
or otherwise use the products mentioned. A company-sponsored program 
that discusses use of a company product carries with it, at the least, 
an implicit solicitation, and in many cases an explicit one (cf. 
Central Hudson, 100 S.Ct. at 2352 (suggesting that most businesses are 
unlikely to underwrite promotions that are of no interest to 
consumers); National Commission on Egg Nutrition v. FTC, 570 F.2d 157 
(7th Cir. 1977) (advertisement by egg industry trade association 
claiming no relationship between eggs, cholesterol, and heart disease 
constitutes commercial speech)).
    Indeed, a review of the medical literature on industry-supported 
scientific and educational activities demonstrates that such activities 
are economically motivated and propose a commercial transaction. It is 
significant to note that the number and cost of drug company-supported 
symposia have increased significantly over the years. In 1974, 16 drug 
companies sponsored 7,519 symposia, at a cost of 6.5 million dollars. 
Roughly comparable figures showed that in 1988 the same companies 
sponsored 34,688 symposia at a cost exceeding 85.9 million dollars.\3\ 
It is reasonable to conclude that drug companies would not spend such 
large sums of money if they did not view these programs as an effective 
means to promote their products. Numerous reports in the medical 
literature support this conclusion.
---------------------------------------------------------------------------

    \3\ Senate Labor and Human Resources Committee, Congressional 
Research Service, Survey of selected pharmaceutical firms, 
Washington, DC, Government Printing Office, 1991.
---------------------------------------------------------------------------

    In an article entitled ``Physicians and the Pharmaceutical 
Industry: An Alliance with Unhealthy Aspects,'' 36 Perspectives in 
Biology and Medicine 376-394, 385 (Spring 1993), author Robert C. Noble 
describes industry-sponsored symposia as, ``an effective method for 
marketing new drugs,'' and explains that, ``[t]he symposium, like the 
promotional dinner, is frequently given a neutral title that disguises 
any promotional purpose * * *'' (emphasis added). (See also Lisa Bero, 
Alison Galbraith, and Drummond Rennie, ``The Publication of Sponsored 
Symposiums in Medical Journals,'' New England Journal of Medicine, 
327:1135-1140, 1992 (demonstrating that published symposia were 
promotional and not peer-reviewed, and those that were sponsored by a 
single company focused on single products, had misleading titles, and 
featured unapproved drugs).)
    It has also been suggested that drug companies will not provide 
financial support for scientific and educational activities unless 
those activities in some way promote the supporting company's products. 
An editorial by Stephen E. Goldfinger, in the New England Journal of 
Medicine, addressed the growing support and influence of the drug 
industry in the education of physicians. According to Dr. Goldfinger:
    The most acceptable kind of educational backing is the least 
available: donations to providers of continuing medical education 
that are unrestricted with respect to program topics, speakers, or 
the backgrounds of the invited registrants. When I have suggested 
this model to pharmaceutical directors who proclaim a genuine 
interest in supporting continuing medical education, the usual 
response is a quizzical smile followed by a gentle reminder of the 
value of confining our discussion to the realm of the possible. At a 
minimum, that realm usually requires the topic to be an area ``of 
interest'' to the sponsor, meaning an area related to a product line 
in need of promotion.
Stephen E. Goldfinger, ``A Matter of Influence'' (Editorial), New 
England Journal of Medicine, pp. 1408-1409, 1409 (May 28, 1987).
Similarly, 2 years later, Eugene M. Bricker, wrote in the same journal 
that:
    Most of the medical-service industry's marketing exercises are 
intended to be both educational and promotional, and some are indeed 
broadly educational and of excellent quality. This does not alter 
the fact that promotion is their basic objective; companies would 
not subsidize marketing methods unless they were rewarding.
Eugene M. Bricker, ``Industrial Marketing and Medical Ethics'' 
(Editorial), New England Journal of Medicine, pp. 1690-1692, 1691 (June 
22, 1989). (See also Kenneth Miller, William A. Gouveia, Michael Barza, 
et al., ``Undesirable Marketing Practices in the Pharmaceutical 
Industry'' (Letter to the Editor), New England Journal of Medicine, p. 
54 (July 4, 1985) (Physician and pharmacist members of a hospital 
pharmacy committee expressing concern that drug company grants to 
support educational functions, such as talks by visiting speakers, are 
sometimes clearly linked to a request for the admission of a drug to 
the hospital's formulary or increased use of the product).)
    Moreover, the results of a study by Marjorie A. Bowman and David L. 
Pearle, ``Changes in Drug Prescribing Patterns Related to Commercial 
Company Funding of Continuing Medical Education,'' Journal of 
Continuing Education in the Health Professions, 8:13-20, 1988, confirm 
that industry-supported scientific and educational activities propose a 
commercial transaction. Doctors Bowman and Pearle analyzed the drug 
prescribing patterns of physicians attending three different continuing 
medical education (CME) courses, each of which was subsidized heavily 
by a single, but different drug company. The course topics were 
directly related to a set of similar drugs from the same class. 
Immediately prior to and 6 months after

[[Page 64079]]

each course, the physician attendees were asked to identify the 
frequency of prescriptions written for the set of drugs. Despite the 
presumed independence of CME course content, in all three courses the 
rate of prescribing for the drug of the sponsoring company increased 
the greatest in absolute terms, while prescribing rates for the other 
drugs discussed in the program either decreased or did not increase as 
much. Thus, company funding of such programs does appear to influence 
physicians' drug prescribing behavior in favor of the sponsoring 
company's product. (See also Jerry Avorn, Milton Chen, and Robert 
Hartley, ``Scientific and Commercial Sources of Influence on the 
Prescribing Behavior of Physicians,'' American Journal of Medicine, 
73:4-8, 1982 (demonstrating that commercial sources have greater 
influence over prescribing behavior than scientific sources of 
information); Robert S. Stern, ``Drug Promotion for an Unlabeled 
Indication--The Case of Topical Tretinoin,'' New England Journal of 
Medicine,'' 331:1348-1349, 1994 (demonstrating that reports of company-
sponsored studies and promotional efforts, including symposia, were 
associated with a large increase in prescribing for an unapproved 
indication).)
    Thus, if industry-supported scientific and educational activities 
constitute protected speech, that speech is ``commercial speech'' for 
purposes of constitutional analysis.
3. The Central Hudson Analysis
    Over the past few decades, the Supreme Court has afforded 
commercial speech limited constitutional protection (Virginia State 
Board of Pharmacy v. Virginia Citizens Consumer Council, Inc., 96 S.Ct. 
1817 (1976); Central Hudson, 100 S.Ct. at 2343; 44 Liquormart, Inc. v. 
Rhode Island, 116 S.Ct. 1496 (1996)). In Central Hudson, the Supreme 
Court established a four-prong test to determine whether limitations on 
commercial speech are constitutional. The test inquires: (1) Whether 
the speech concerns lawful activity and is not misleading; (2) whether 
the asserted government interest is substantial; (3) whether the 
limitation directly advances the governmental interest asserted; and 
(4) whether the limitation is not more extensive than is necessary to 
serve that interest (Central Hudson, 100 S.Ct. at 2351). Subsequently, 
in S.U.N.Y. v. Fox, 109 S.Ct. 3028 (1989), the Court clarified that the 
fourth prong of the Central Hudson test is not a ``least restrictive 
means'' requirement; rather it requires that the restriction be 
``narrowly tailored'' to serve the asserted government interest. Narrow 
tailoring means ``a fit that is not necessarily perfect, but 
reasonable'' between means and ends (Id. at 3035).
    FDA's guidance on industry-supported scientific and educational 
activities satisfies all four prongs of the Central Hudson test.
    a. The first prong. Commercial speech that is false or misleading, 
or that concerns illegal activity, is not protected by the First 
Amendment and may be banned (Zauderer v. Office of Disciplinary 
Counsel, 105 S.Ct. 2265, 2275 (1985); Ibanez v. Board of Accountancy, 
114 S.Ct. 2084, 2088 (1994)). Commercial speech is misleading when it 
is either inherently likely to deceive or when experience has shown 
that the speech has in fact been deceptive (In Re R.M.J., 102 S.Ct. 
929, 937 (1982)). Regulation of commercial speech that is not 
misleading, or that is only potentially misleading, must satisfy the 
remaining prongs of the Central Hudson test.
    As previously discussed, industry-supported scientific and 
educational activities that promote an unapproved product, or promote 
an approved product for an unapproved use, create an unlawful product--
a misbranded or adulterated drug or device. Accordingly, industry-
supported activities that promote unlawful products ``concern illegal 
activity'' and may be prohibited.
    Although FDA believes that most industry-supported scientific and 
educational activities are not inherently misleading, they are clearly 
potentially misleading. The potential to mislead the listener (a health 
care professional) at such an activity is heightened because the 
listener must not only determine whether the information presented is 
scientifically sound, but also whether, or to what extent, the 
supporting company has influenced the presentation.
    Evidence of bias in the content of industry-supported CME programs 
was demonstrated in a study conducted by Marjorie A. Bowman. Dr. Bowman 
analyzed the content of two CME programs on calcium channel blocker 
drugs (approved for treating high blood pressure) that were funded by 
different drug companies. In each case, the program speakers mentioned 
positive effects more often in connection with the sponsoring company's 
drug and negative effects more often with competitors' drugs.\4\ A 
second study that analyzed the publication of industry-sponsored 
symposia in medical journals concluded that the symposia were 
promotional in nature and not peer-reviewed, and those that were 
sponsored by single pharmaceutical companies focused on single drug 
products, had misleading titles, and featured unapproved drugs.\5\ 
Additionally, there are numerous reports in the medical literature 
describing deceptive practices in the design and delivery of industry-
supported symposia. See e.g., Robert C. Noble, ``Physicians and the 
Pharmaceutical Industry: An Alliance with Unhealthy Aspects,'' 36 
Perspectives in Biology and Medicine 376-394 (Spring 1993); ``Pushing 
Drugs to Doctors,'' Consumer Reports, 57:87, Feb. 1992 (reporting on 
drug industry marketing practices that mislead doctors).
---------------------------------------------------------------------------

    \4\ Marjorie A. Bowman, ``The Impact of Drug Company Funding on 
the Content of Continuing Medical Education,''Mobius, 6:66-69, 
January 1986.
    \5\ Lisa Bero, Alison Galbraith, and Drummond Rennie, ``The 
Publication of Sponsored Symposiums in Medical Journals,''New 
England Journal of Medicine, 327:1135-1140, 1992.
---------------------------------------------------------------------------

    The potential to present misleading information at industry-
supported activities is a particular concern when unapproved uses are 
addressed. Usually, unapproved uses have not been vigorously evaluated, 
or if they have been studied, the results are inconclusive. Thus, 
unapproved uses tend to lack the same degree of certainty and 
confidence as FDA approved uses. In fact, the data that can identify 
risks associated with the unapproved use often do not exist, and 
therefore complete information about the risks of the new use cannot be 
provided. This lack of data, of course, does not make all discussions 
about unapproved uses misleading. However, it is important that the 
audience understand the limitations on data supporting unapproved uses. 
The disclosure of such limitations, as recommended in the Final 
Guidance, will help ensure that the audience understands the 
uncertainty associated with unapproved uses and not be misled into 
thinking that such uses are safe and effective.
    b. The second prong. FDA's guidance on industry-supported 
scientific and educational activities serves the substantial Government 
interest of protecting the health and safety of its citizens by helping 
to ensure the dissemination of truthful and nonmisleading information 
about drugs and medical devices. The Supreme Court has repeatedly held 
that the Government's ``interest in the health, safety, and welfare of 
its citizens constitutes a substantial interest'' (Posadas de Puerto 
Rico Associates v. Tourism Co., 106 S.Ct. 2968, 2977

[[Page 64080]]

(1986); Rubin v. Coors, 115 S.Ct. 1585, 1591 (1995)).
    In order to protect and promote the public health, Congress granted 
FDA broad statutory authority to ensure that promotional activities 
(labeling and advertising) for drugs and devices are truthful and not 
misleading. Section 502(a) of the act provides that a drug or device is 
deemed to be misbranded if its labeling is false or misleading in any 
particular, and under section 502(q) of the act a restricted medical 
device is misbranded if its advertising is false or misleading in any 
particular. A prescription drug is misbranded under section 502(n) of 
the act unless the manufacturer, packer, or distributor includes in all 
advertisements with respect to that drug, ``a true statement of * * * 
information in brief summary relating to side effects, 
contraindications, and effectiveness * * *.''\6\ Similarly, a 
restricted device is misbranded under section 502(r) of the act unless 
the manufacturer, packer, or distributor includes in all advertisements 
with respect to that device, ``a true statement of * * * the intended 
uses of the device and relevant warnings, precautions, side effects, 
and contraindications * * *.'' Moreover, section 201(n) of the act 
specifically explains that if an article is alleged to be misbranded 
because the labeling or advertising is misleading, there shall be taken 
into account not only representations or suggestions made in the 
labeling or advertising, but also the extent to which the labeling or 
advertising fails to reveal material facts. The dissemination of false 
or misleading information about drugs and devices can induce physicians 
to choose therapies that deprive patients of reliable treatment and 
cause severe morbidity, life-threatening adverse effects, or death.
---------------------------------------------------------------------------

    \6\ The prescription drug advertising regulations, issued under 
section 502(n) of the act, provide that an advertisement does not 
satisfy the requirement that it present a ``true statement'' of 
information in brief summary if it is false or misleading with 
respect to side effects, contraindications, or effectiveness (see 21 
CFR 202.1(e)(5)(i)). In addition, the regulations list 33 ways in 
which prescription drug advertisements may be false or misleading 
(see 21 CFR 202.1(e)(6) and (e)(7)).
---------------------------------------------------------------------------

    FDA's guidance also serves to protect the public health by 
preserving the integrity of the premarket approval process, a second 
substantial government interest. As explained earlier, by enacting the 
act, Congress established a premarket approval and clearance process 
whereby manufacturers must establish that their drugs and devices are 
safe and effective for each of their intended uses before they can be 
marketed and promoted for those uses. Manufacturers of drugs and 
devices are not permitted to promote unapproved products or unapproved 
uses of approved products, either directly or indirectly, such as 
through industry-supported scientific and educational activities. This 
regulatory requirement is an important incentive for manufacturers to 
conduct studies to determine whether their products are safe and 
effective. If premarket approval were not required for each intended 
use and manufacturers were free to promote products for any use, 
manufacturers would have little reason to do scientific research and to 
present their data to FDA. Additionally, it is important to note that 
the approval of a drug or device for one use does not provide assurance 
that the product is safe or effective for a different use or use in a 
different patient population. Consequently, the promotion of unapproved 
uses raises significant safety concerns, which are more fully discussed 
below.
    c. The third prong. FDA's guidance on industry-supported scientific 
and educational activities directly advances the government's 
substantial interests. ``[A] governmental body seeking to sustain a 
restriction on commercial speech must demonstrate that the harms it 
recites are real and that its restriction will in fact alleviate them 
to a material degree'' (Edenfield v. Fane, 113 S.Ct. 1792, 1800 
(1993)).
    FDA's guidance directly advances the Government's interest of 
protecting the health and safety of its citizens by helping to ensure 
the dissemination of truthful and nonmisleading information about drugs 
and devices. The guidance includes a number of suggestions on the 
design and conduct of industry-supported scientific and educational 
activities so that they will be free from the promotional influence of 
the supporting company and not misleading. Such suggestions include, 
for example, meaningful disclosure of the company's funding of the 
program and any significant relationship between the provider (an 
entity, other than a regulated company, that produces the activity or 
program), presenter, and supporting company; giving the provider full 
control over the content of the program and selection of speakers; 
avoiding involvement of the sales or marketing departments of the 
supporting company in audience selection decisions; and not having 
promotional activities in the meeting room. Industry-supported 
activities that are designed and carried out in this manner are less 
likely to result in the dissemination of false, misleading, or biased 
information that can adversely affect public health.
    On a number of occasions, FDA has become aware of and taken action 
against industry-supported scientific and educational activities that 
were false or misleading, and that could have caused harm to patients. 
For example, a few years ago, agency staff viewed two videotaped 
presentations on treating gallstone disease that were broadcast 
nationwide on a cable television network intended for physicians. The 
videos were produced and paid for by a major drug company and 
prominently featured a drug marketed by the company for the chemical 
dissolution of certain gallstones. The programs encouraged doctors to 
prescribe this drug instead of surgery to treat gallstone disease. 
These representations and suggestions were false or misleading because: 
(1) The drug is approved only for dissolving certain types and sizes of 
gallstones in patients for whom surgery is not medically appropriate, 
or for patients who refuse surgery, and (2) surgery is more effective 
and is the preferred treatment for almost all patients with gallstone 
disease.
    These industry-sponsored presentations could have caused many 
physicians to make inappropriate and potentially harmful treatment 
decisions. After FDA notified the sponsoring company that the programs 
were false or misleading, the company agreed to take appropriate 
corrective action.
    In a more recent example, a major drug company sponsored a 
misleading symposium on cyclosporine drug products (approved to prevent 
organ rejection in kidney, liver, and heart transplant patients), held 
in conjunction with the annual meeting of the American Society of 
Transplant Physicians. The sponsoring company's ``pioneer'' 
(nongeneric) cyclosporine drug product was about to lose patent 
protection and face competition from lower-priced generic cyclosporine 
products at the time of the symposium.
    An investigation by FDA revealed that the sponsoring company and 
its agent specifically requested that one invited speaker revise his 
abstract to remove any references to the impending availability of 
generic cyclosporine products, to delete or revise sections of text 
that did not support switching stable patients to the sponsoring 
company's product, and to make other revisions to his presentation. 
Despite the speaker's insistence on including his abstract as 
originally written, the sponsoring company again asked the speaker to 
revise his abstract and presentation. When the speaker again refused to 
revise his abstract, it was not

[[Page 64081]]

included in the program materials disseminated during the symposium.
    The sponsoring company's actions to control the content of the 
symposium resulted in a misleading presentation in that: (1) The 
sponsoring company implied that the speakers were speaking without 
editorial input or influence from the sponsoring company, and (2) the 
sponsoring company foreclosed a full discussion of all cyclosporine 
drug products. The sponsoring company's efforts undermined the unbiased 
exchange of scientific information, may have caused physicians to 
unnecessarily switch stable patients to the company's product, and 
likely resulted in greater than necessary expenditures by patients. 
This might not have been the case had the sponsoring company, 
consistent with the agency's longstanding policy as articulated in the 
Draft Policy Statement, not influenced the content of the program.
    FDA's guidance also directly advances the Government's interest of 
protecting the public health by preserving the integrity of the 
premarket approval process. The act requires sponsors to establish that 
their drugs and devices are safe and effective for their intended uses 
before they can be marketed and promoted. Consistent with this 
statutory scheme, FDA has consistently prohibited the promotion of 
unapproved products and unapproved uses of approved products. As 
explained earlier, this preserves the incentive for sponsors to conduct 
the adequate and well-controlled clinical investigations that are 
necessary to demonstrate whether products are safe and effective for 
each of their intended uses, and prevents patients from being exposed 
to unnecessary harms. There are, unfortunately, several examples of 
harms associated with the promotion of unapproved uses.
    For example, several manufacturers of calcium channel blockers 
(drugs approved to treat a type of chest pain known as angina) 
attempted to promote these products for use in patients who had 
recently suffered heart attacks, called acute myocardial infarctions 
(post-AMI patients). The use of calcium channel blockers in post-AMI 
patients is not an approved use, and the agency successfully thwarted 
these promotional efforts. Many studies of post-AMI calcium channel 
blocker use have failed to show benefits, and some studies suggest that 
they may cause harm, particularly in patients with poor heart function. 
Given the many patients who suffer an AMI each year, the loss of life 
could have been in the thousands if the manufacturers had promoted this 
use.
    In another example, certain approved anti-arrhythmic drugs were 
illegally promoted for unapproved uses in post-AMI patients. Included 
in these promotional activities were industry-sponsored lectures, 
presentations, and other publicity events. Use of anti-arrhythmic drugs 
for this unapproved use was substantial and growing until a clinical 
study (the CAST study) was conducted to evaluate definitively the 
safety and effectiveness of this use. The study produced a highly 
unexpected result in that the treatment with anti-arrhythmic drugs 
produced a 2.5-fold increase in mortality. It is estimated that tens of 
thousands of deaths were associated with this unapproved use.\7\
---------------------------------------------------------------------------

    \7\ More Information for Better Patient Care: Hearing on S. 1477 
Before the Senate Comm. on Labor and Human Resources, 104th Cong. 
51, 78-79 (1996) (statement of Thomas J. Moore, Senior Fellow, 
Center for Health Policy Research, George Washington University).
---------------------------------------------------------------------------

    More detailed information on the preceding examples and additional 
examples involving drugs, biologics, and devices are contained in an 
FDA Federal Register notice requesting comments on a citizen petition 
submitted by the Washington Legal Foundation (see 59 FR 59820, November 
18, 1994).
    FDA's guidance on industry-supported scientific and educational 
activities protects the integrity of the premarket approval process 
because it dissuades manufacturers from using such activities as a 
means to promote unapproved products and unapproved uses; thereby 
encouraging scientific research and eliminating unnecessary harms to 
patients. At the same time, however, the agency acknowledges that drug 
and device manufacturers have an important role in legitimate 
scientific and educational discussions, including discussions of 
unapproved products and unapproved uses. Accordingly, the guidance 
recognizes that discussions of unapproved uses at industry-sponsored 
activities may be appropriate, and suggests that the provider include a 
general disclosure to the audience as to whether any unapproved uses 
will be discussed. This disclosure accommodates the need for industry-
supported discussion on unapproved uses, yet helps ensure that the 
information presented is not misleading so as to be misconstrued as 
discussion of an approved use.
    d. The fourth prong. The agency believes that the guidance is 
``narrowly tailored'' and a reasonable approach to protect the health 
and safety of consumers by discouraging the dissemination of misleading 
or biased information, and by maintaining the integrity of the 
premarket approval process. The ``Factors Considered in Evaluating 
Activities and Determining Independence,'' in section II.A. of the 
Final Guidance, are ``reasonable means'' of distinguishing industry-
supported activities that are intended to be promotional from those 
that are intended to be nonpromotional and free from the supporting 
company's influence and bias.
    The Supreme Court has expressed a willingness to defer the fourth-
prong determination to the regulating body. (See Fox, 109 S.Ct. at 
3035; United States v. Edge Broadcasting Co., 113 S.Ct. 2696, 2707 
(1993).) Since Fox, the Court has applied the ``reasonable fit'' 
standard to uphold the regulation of commercial speech. (See Edge, 113 
S.Ct. at 2705; Florida Bar v. Went For It, Inc., 115 S.Ct. 2371, 2380 
(1995).) Moreover, the courts have granted greater leeway and upheld 
reasonable regulation of commercial speech with regard to potentially 
harmful activities. (See Edge, 113 S.Ct. 2696 (upholding Federal 
prohibition of lottery advertising on radio in nonlottery State); 
Anheuser-Busch, Inc. v. Schmoke, 63 F.3d 1305 (4th Cir. 1995), cert. 
denied, 65 U.S.L.W. 3723 (April 28, 1997) (No. 96-1428) (upholding 
restrictions on outdoor advertising of alcoholic beverages); Penn 
Advertising of Baltimore, Inc. v. Mayor and City Council of Baltimore, 
63 F.3d 1318 (4th Cir. 1995), cert. denied, 65 U.S.L.W. 3723 (April 28, 
1997) (No. 96-1428) (upholding restrictions on outdoor advertising of 
cigarettes).) Certainly, with regard to the regulation of potentially 
dangerous drugs and medical devices, FDA is entitled to the same, if 
not greater, deference.
    FDA's guidance on industry-supported scientific and educational 
activities is narrowly tailored. The guidance applies only to those 
industry-supported activities that relate to the supporting-company's 
product(s) or to competing product(s). It is directed to the regulated 
sponsors of such activities (drug and device manufacturers) rather than 
the participating professionals. It does not apply at all to 
independent scientists and organizations (e.g., universities, medical 
societies, professional groups), which may freely participate in or 
sponsor scientific or educational activities. Additionally, the agency 
has made clear that it does not seek to regulate all industry-supported 
scientific and educational activities under the labeling and 
advertising provisions of the Act. As explained in the guidance, FDA 
has not regulated and does not intend to regulate industry-supported 
activities that are

[[Page 64082]]

independent of the promotional influence of the supporting company.
    The Final Guidance suggests that the provider ensure:
    [M]eaningful disclosure, at the time of the program, to the 
audience of: (1) the company's funding of the program; (2) any 
significant relationship between the provider, presenters or 
moderators, and the supporting company (e.g., employee, grant 
recipient, owner of significant interest or stock); and (3) whether 
any unapproved uses of products will be discussed.
These disclosures are fully consistent with the First Amendment. (See 
Virginia Board of Pharmacy, 96 S.Ct. at 1830 n. 24 (``They may also 
make it appropriate to require that a commercial message appear in such 
a form, or include such additional information, warnings, and 
disclaimers, as are necessary to prevent its being deceptive.''); In Re 
R.M.J., 102 S.Ct. at 926 (``a warning or disclaimer might be 
appropriately required * * * in order to dissipate the possibility of 
consumer confusion or deception.''); Zauderer, 105 S.Ct at 2282 and 
n.14 (holding that disclosure requirements do not violate the First 
Amendment as long as they are reasonably related to the state's 
interest in preventing deception, and indicating that disclosure 
requirements are one of the acceptable less restrictive alternatives to 
actual suppression of speech).)
    The agency's suggested disclosures are reasonably related to 
ensuring that the audience is in a position to fully evaluate the 
information presented, in order to avoid being misled, confused, or 
deceived. The guidance suggests that the disclosures be ``meaningful'' 
and ``to the audience.'' It does not specify how or when during the 
activity the disclosures should be delivered, or what should be said. 
Furthermore, as explained previously, the guidance suggests that the 
provider disclose whether any unapproved uses of products will be 
discussed. It recognizes that discussions of unapproved uses may be 
appropriate.
    Finally, in response to comments, the agency made revisions to the 
Draft Policy Statement (reflected in the Final Guidance) that are 
additional evidence of ``narrow-tailoring.'' The most significant 
change was to place less emphasis on the elements of a written 
agreement between the supporting company and the provider, and instead 
provide guidance on what the agency will consider in evaluating 
activities and determining independence (Factors Considered in 
Evaluating Activities and Determining Independence). The Final Guidance 
makes clear that the list of factors is not exhaustive and that other 
factors may be appropriate for consideration in a particular case. The 
supporting company and the provider are free to adopt alternative 
approaches to help ensure that activities are independent and 
nonpromotional.
4. Conclusion
    FDA strongly believes that the Draft Policy Statement and the Final 
Guidance on Industry-Supported Scientific and Educational Activities do 
not abridge the First Amendment because the agency's ability to 
regulate such activities is essential to the regulation of drugs and 
devices, and the regulation of drugs and devices is an area of 
extensive Federal regulation. If however, such activities are 
considered protected speech, they are commercial speech. The guidance 
satisfies all prongs of the Central-Hudson test, and thus, does not 
violate the First Amendment.

C. Scope

    4. Several comments from the medical device industry argued that 
medical devices should be exempt from the policy. Some comments 
recommended, in the alternative, that there be a separate policy 
specific to medical devices. They argued that the policy initiative 
resulted from an effort to address abuses in the pharmaceutical 
industry, and that such abuses are not characteristic of the 
educational programs supported by medical device companies. Moreover, 
they maintained that educational programs for devices are more in the 
nature of hands-on training programs and thus present unique issues 
that would make compliance with a number of provisions of the draft 
policy statement (e.g., multiple presentations, audience selection) 
impractical or impossible.
    The agency declines to exempt medical devices from the final 
guidance. The statutory concepts of labeling, advertising, and intended 
use do not differ for drugs and medical devices. ``Hands-on'' training 
sessions sponsored by device manufacturers are inherently product-
specific and generally do not fall within the description of 
independent and nonpromotional educational programs that are 
contemplated by the final guidance. Training provided or supported by 
device manufacturers related to labeled uses would present no 
difficulty for the sponsor. Industry-supported training for off-label 
uses, however, will ordinarily be viewed by the agency as violative of 
the act.
    5. Several comments from the animal drug industry and the 
veterinary community contended that animal drugs should be exempt from 
the policy. They argued that the animal drug industry is not prone to 
the same abuses as the human drug industry, that the process by which 
continuing education programs are provided to veterinarians is not 
comparable to the process by which continuing education is provided to 
other health care professionals, and that the administrative burdens 
and resulting expense imposed by the policy would restrict the 
availability of educational programs for veterinarians.
    The agency acknowledges that the processes by which continuing 
education is provided for veterinary health care professionals differs 
in many ways from continuing education for other health care 
professionals. Nevertheless, the basic principles embodied in the final 
guidance, the importance of independence, disclosure, and educational 
design and intent apply to veterinary continuing medical education just 
as they apply to other industry-sponsored professional education.
    6. Several comments addressed the scope of activities that are 
affected by the policy. Some comments contended that the scope of the 
policy has been appropriately narrowed to scientific and educational 
activities directed to health care professionals. They supported the 
exclusion of activities directed at business, policy, or other 
nonhealth care professional groups. Other comments argued that the 
scope should be narrowed further to encompass only those industry-
supported educational activities directed to health care professionals 
who are involved in prescribing or administering regulated products. 
Several comments expressed concern that the scope of activities to 
which the policy applies, beyond live presentations, is unclear. They 
expressed concern about the extent to which the policy applies to 
presentations in electronic and other media. They contended that the 
policy should set forth the limitations of its application and, 
moreover, should expressly exempt written materials from the scope of 
its application.
    Although this final guidance is intended to address industry-
supported scientific and educational activities directed to health care 
professionals, the agency anticipates that presentations to other 
audiences may lend themselves to the principles described in this final 
guidance. It is understood that a large majority of health care 
professionals participate in the diagnostic and therapeutic management 
of patients and are, therefore, in a position to either prescribe, 
influence prescribing, or monitor the effectiveness of regulated 
medical products. Information

[[Page 64083]]

presented at continuing education programs may have a significant 
impact on these health care professionals.
    There is no basis for applying a substantially different policy to 
industry-supported educational or scientific activities that are 
broadcast, electronically recorded, or disseminated via other emerging 
media.
    7. One comment requested that the agency clarify that the policy 
applies generally to continuing medical education and also to industry-
supported educational activities directed to health care professionals. 
The comment was concerned that the reference to continuing medical 
education, in the first sentence of the first paragraph of the 
background section of the draft policy statement, suggests that the 
scope of the policy may be limited to continuing medical education.
    The agency agrees with the comment and has revised the language to 
refer to ``continuing education for health care professionals.''
    8. One comment was concerned that the language in the background 
section of the draft policy statement implies that only independent 
activities, as described in the draft policy statement, can be 
considered educational activities. The comment stated that accredited 
educational activities that are not free from company influence, yet 
not inconsistent with approved labeling for any company product 
discussed, will no longer be regarded as legitimate educational 
activities.
    The final guidance is not intended to distinguish between education 
and promotion and does not suggest that company influenced activities 
are illegitimate or noneducational. To clarify this intent, FDA has 
added a sentence to the background section, which states that the 
agency recognizes that industry-supported activities can be both 
nonpromotional and educational. The final guidance is intended to 
distinguish between industry-supported activities that the agency does 
not intend to regulate because they are otherwise independent of 
company influence and those that are subject to regulation because of 
the substantive influence of the supporting company. Company-influenced 
activities that provide information to health care professionals on 
regulated products may be educational in nature. They are, 
nevertheless, subject to regulation and, thus, must be consistent with 
approved labeling.
    9. Some comments were concerned that the policy narrows or 
eliminates the ability of companies to engage in scientific exchange as 
provided for in Sec. 312.7(a) (21 CFR 312.7(a)) (human drugs) and 
Sec. 511.1(b)(8)(iv) (21 CFR 511.1(b)(8)(iv)) (animal drugs). The 
comments contended that the draft policy statement seems to subject 
company-controlled scientific exchange to regulation because it is not 
an independent activity. They contended that appropriate company-
controlled scientific exchange should be expressly exempted from 
regulation in the policy.
    This final guidance seeks to clarify the distinction between the 
concepts of promotion/commercialization and industry-supported 
scientific exchange set forth in Secs. 312.7(a) (human drugs) and 
511.1(b)(8)(iv) (animal drugs). Programs supported by companies that 
are not otherwise independent scientific or educational activities are 
subject to regulation as product promotion/commercialization.
    10. Several comments contended that the policy is fundamentally 
flawed in that it institutionalizes industry support for continuing 
education activities for health care professionals. One comment argued 
that part of the definition of continuing medical education should be 
that it is nonsubsidized. Other comments recommended that the agency 
encourage multiple-source funding for educational activities to 
minimize the potential for bias as the policy may not be adequate to 
prevent the subtle bias inherent in a single sponsor situation.
    The ``institutionalization'' of industry support for continuing 
education predates the agency's draft policy statement. The agency has 
sought to avoid, through its policy, undue interference with the 
availability of continuing education. Although FDA shares the concerns 
of some health care professionals that substantial reliance on industry 
funding may result in bias in continuing education, such should be 
addressed by the profession rather than by the agency. Although 
enlisting multiple sponsors would likely reduce the potential for bias 
toward any one product, the agency believes that this approach may not 
be practical, in all instances, for all FDA-regulated products.

D. Background: Promotion, Education, and Independence

    11. Some comments objected to language in the background section of 
the draft policy statement indicating that, in assessing whether an 
industry-supported activity is independent, the agency will examine 
whether and to what extent the company ``is in a position to 
influence'' the presentation. They contended that the correct inquiry 
is whether a company has actually influenced a presentation, not 
whether a company was in a position to influence the presentation.
    The agency cannot, in all cases, presume a provider to be 
independent merely because there is no documented attempt by the 
supporting company to influence the program. Business relationships or 
other relationships may influence a provider. A provider whose 
continued existence depends on the funding and goodwill of a supporting 
company may, for practical purposes, be in the same position as a 
company employee, who depends on his or her salary. Whether or not a 
company is in a position to influence the presentation is important in 
determining whether the activity is independent.
    12. One comment objected to the first sentence of the fifth 
paragraph to the background section of the draft policy statement; this 
sentence indicated that, in assessing whether an activity is 
independent, the agency will examine whether and to what extent the 
company is in a position to ``otherwise use the presentation as an 
advertising vehicle.'' The comment contended that this language is 
ambiguous as to what might cause the agency to conclude that a 
supporting company has otherwise used a presentation as an advertising 
vehicle.
    The agency agrees that clarification may be helpful. Accordingly, 
FDA has revised the text to state that the agency will examine whether 
and to what extent the company is in a position to ``otherwise 
transform an ostensibly independent program into a promotional 
vehicle.''
    13. One comment suggested that the example provided in the 
parenthetical statement in the fifth paragraph to the background 
section of the draft policy statement (57 FR 56412 at 56413) be changed 
from ``if the provider believes that future financial support from the 
company depends upon producing programs that promote the company's 
product'' to ``if the provider has reason to believe * * *.''
    The agency agrees with the suggested change and has revised that 
section of the final guidance accordingly.

E. Policy: Scientific and Educational Activities Supported by Industry

    The draft policy statement, in discussing FDA policy generally, 
stated that the agency ``has not regulated and does not intend to 
regulate under the labeling and advertising provisions of the act 
industry-supported scientific and educational activities that are 
independent of the influence of the supporting company'' (57 FR 56412 
at 56413). The agency further stated that

[[Page 64084]]

``companies and providers who wish to ensure that their activities will 
not be subject to regulation should design and carry out their 
activities based on a written agreement * * * that the provider will be 
solely responsible for designing and conducting the activity * * *.''
    14. Some comments contended that to make the provider solely 
responsible for design and conduct of an educational activity 
excessively restricts supporting company involvement. They suggested 
revising the text to make the provider ``ultimately'' responsible for 
design and conduct of an educational activity.
    In order to maintain the concept of independence described in this 
final guidance, it is important to retain the concept of provider 
``sole responsibility'' for the design and conduct of the activity. 
This guidance is not designed to restrict companies from continuing to 
provide programs for health care professionals, but to distinguish 
between activities that are otherwise independent from the promotional 
influence of the supporting company and those that are not. A provider 
who merely adopts a company-designed presentation has not functioned as 
a truly independent educational provider.
1. Written Agreement--Generally
    Although the draft policy statement did not require a written 
agreement, it did state that a written agreement can ``play an 
important role in helping to ensure that an industry-sponsored activity 
comes within the safe harbor traditionally recognized by the agency for 
independent scientific and educational activities'' (57 FR 56412 at 
56413). The draft policy statement also described 10 elements the 
agency would anticipate in such written agreement.
    As discussed in comment 15 of section II.E.1. of this document, the 
final guidance was modified to place less emphasis on a written 
agreement, but states that a written agreement is one way to document 
what measures were taken by the parties to maintain the independence of 
an activity.
    15. Several comments suggested that a written agreement between the 
provider and supporting company was required and overly burdensome, 
both substantively and administratively. These comments identified a 
number of possible consequences including, foremost, that the written 
agreement would function as a disincentive for industry to support 
continuing education, resulting in fewer and lower quality educational 
activities. Several comments objected to the written agreement in 
general as overly restrictive and intrusive, containing too many 
elements, unwieldy, and/or impractical. The comments suggested, among 
other things, that there should be no requirement at all, that the 
agreement should provide only that the provider exercises final control 
and that the agreement should provide only that the program be 
objective, balanced, and scientifically rigorous, and that there be 
disclosure with all other details left to the parties. Other comments 
recommended that the agency develop a ``generic'' written agreement, or 
alternatively, provide guidance to national accrediting organizations 
as to the content of acceptable standardized written agreements. Still 
other comments were supportive of the concept of a written agreement, 
did not anticipate that written agreements would be unduly burdensome, 
and moreover, maintained that the written agreement would improve the 
process of developing meaningful educational activities. Some comments 
suggested that, for their purposes, the fact that clear guidance, which 
distinguishes regulated from nonregulated activities exists, may be 
more important than what the guidance actually contains. The comments 
complained that the lack of guidance, and resulting uncertainty as to 
the regulatory consequences of industry support for scientific and 
educational activities, have made industry reluctant to provide support 
for these activities.
    As noted earlier, the agency has clarified its intention that a 
written agreement between the supporting company and the provider is 
recommended, and not required. The final guidance recognizes that a 
written agreement is one way of documenting the measures taken by the 
provider and the supporting company to ensure independence of an 
activity. The agency does not anticipate that a written agreement would 
be an undue burden for any of the parties involved in continuing 
education for health care professionals. Moreover, the agency 
anticipates that such agreements will enhance, rather than detract 
from, the quality of industry-supported educational activities.
    16. One comment contended that failure to abide by the terms of a 
written agreement should subject the parties to additional penalties 
beyond those currently provided for in the act.
    The agency believes that its existing statutory authority is 
sufficient to address industry-supported activities that are subject to 
regulation and may be violative.
2. Statement of Purpose
    The draft policy statement's ``Statement of Purpose'' section 
(section II.A.1.) advised that the company and the provider should 
agree that the program ``is for scientific or educational purposes and 
not for the purpose of promoting any product and that any discussion of 
the company's products will be objective, balanced and scientifically 
rigorous'' (57 FR 56412 at 56413).
    FDA has deleted the ``Statement of Purpose'' section because the 
elements of a written agreement are no longer described in the final 
guidance.
3. Control of Content/Selection of Presenters
    The draft policy statement stated that the provider would be 
responsible for exercising full control over the planning of the 
program's content, including the selection of presenters and 
moderators. The draft policy statement indicated that companies should 
``play no role in the selection of presenters or moderators other than 
responding to provider requests'' for such persons, but that companies 
could make unsolicited suggestions of speakers to ``nationally 
recognized accrediting organizations that compile lists of speakers * * 
*'' (57 FR 56412 at 56413). The draft policy statement specified 
further details regarding requests for speakers, such as having 
companies agree to provide, where reasonably possible, the names of 
more than one suggested presenter and to ``disclose all known 
significant financial and other relationships between the company and 
suggested presenter.'' The draft policy statement stated that providers 
should agree to seek suggestions for presenters from sources other than 
the company, to make independent judgments on appropriate presenters, 
and to select presenters ``representing an appropriate diversity of 
legitimate medical opinion on the topic under discussion when the 
format permits * * *'' (57 FR 56412 at 56413). Additionally, the draft 
policy statement stated that providers should agree to disclose whether 
a presenter was suggested by the company. The final guidance includes a 
factor concerning ``Control of Content and Selection of Presenters and 
Moderators'' (section II.A.), which contains most of the concepts 
described in the draft policy statement.
    17. Several comments objected to the provision in the draft policy 
statement concerning presenters suggested by the supporting company. 
The comments objected in particular to the statement that the provider 
agrees to disclose

[[Page 64085]]

when it has selected a presenter suggested by the supporting company. 
These comments contended that such disclosure is unnecessary because it 
unfairly raises the specter of bias as to that presenter and, moreover, 
the ``Disclosure of Financial Relationships'' element of the draft 
policy statement (section II.A.3.) provides for adequate disclosure of 
any significant relationship between the presenter and the supporting 
company. Other comments contended that the supporting company should 
under no circumstances be permitted to suggest presenters.
    As stated in the draft policy statement, there is a perceived need 
on the part of some providers for assistance from supporting companies 
in identifying appropriate speakers. The agency is unwilling, at this 
time, to infer undue influence by the supporting company if it responds 
to a request from such a provider. Health care professionals are 
entitled to know the nature of any involvement by supporting companies 
in educational efforts. However, the agency agrees with the comment 
that disclosure of any significant relationship between the provider, 
supporting company, and presenters or moderators would be sufficient. 
The possibility of unwarranted bias against presenters suggested by 
industry should be dealt with in the open environment of scientific 
exchange. Accordingly, the final guidance does not address specific 
disclosure of the supporting company's suggestions for speakers or 
moderators.
    18. Some comments objected to the statement that a supporting 
company, when responding to a provider request for suggestions of 
presenters, agree to disclose all known significant financial and other 
relationships between the suggested presenter and the supporting 
company. They argued that this provision is burdensome and redundant in 
light of the disclosure obligation in the ``Disclosure of Financial 
Relationships'' section of the draft policy statement (section 
II.A.3.).
    The agency believes that a presenter's significant relationships 
with a supporting company are, like a presenter's qualifications, 
essential to a provider's informed decision as to the appropriateness 
of a suggested presenter. Although the final guidance does not 
specifically state that the agency will consider whether the supporting 
company disclosed such relationships, it is suggested that this type of 
disclosure be made.
    The agency does not agree that this disclosure is redundant with 
the ``Disclosures'' section of the final guidance (section II.A.) 
because the two provisions serve different purposes. The disclosure 
made by the supporting company when suggesting a speaker is to assist 
the provider in evaluating the appropriateness of the suggestion. The 
``Disclosures'' section of the final guidance is to inform the 
audience, at the time of the program, of the presenter's relationship 
with the supporting company in order to provide the audience a 
perspective from which to evaluate the information conveyed by the 
presenter. The agency does not view the supporting company's disclosure 
when suggesting a presenter as more comprehensive than the disclosure 
to the audience in the ``Disclosures'' section.
4. Disclosure of Financial Relationships
    The draft policy statement suggested that, as part of the written 
agreement, the provider agrees to ``ensure meaningful disclosure'' of 
the company's funding of the activity and ``any significant 
relationship between the provider and the company and between 
individual presenters or moderators and the company * * *'' (57 FR 
56412 at 56413). In the final guidance, this provision is incorporated 
in the general ``Disclosures'' section.
    19. Several comments sought clarification as to what is meant by 
``meaningful'' disclosure and ``significant'' relationships. Several 
comments also contended that this provision is an administrative 
burden, and that it places a disproportionate burden on the provider, 
as opposed to the supporting company and presenters.
    Significant relationships are relationships that may give rise to 
actual or perceived conflicts of interest. The concept of disclosure of 
relationships that may give rise to conflicts of interest has specific 
and well-understood application to medical and scientific discourse 
(e.g., in publication and in the peer-review process). The agency 
envisions that this provision can be satisfied by disclosing the 
existence of and characterizing significant relationships, and need not 
include further detail such as the amount of compensation or funding 
received. Thus, this disclosure should impose only a minimal burden on 
providers, presenters, and supporting companies. Where there is a 
question as to whether a relationship is significant, providers, 
presenters, and supporting companies should disclose the existence of 
the relationship.
    Meaningful disclosure is disclosure that is reasonably calculated 
to reach the relevant audience in a manner that will alert them to 
potential biases. The provider should determine how to ensure that 
disclosure is meaningful.
    20. One comment contended that significant relationships between 
the supporting company and providers and presenters should preclude any 
characterization of the activity as an independent educational activity 
inasmuch as disclosure is not adequate to cure the taint of influence.
    It is neither practical nor justified to make a potential conflict 
of interest an absolute bar to participation in an independent 
educational activity. Disclosure of such potential conflicts is a 
workable means to address the potential for bias in medical and 
scientific contexts, and there is no reason to believe that it will be 
any less workable in addressing the potential for bias in the context 
of industry-supported scientific and educational activities.
    21. Another comment argued that disclosure is the only element of 
the written agreement that should be retained, that company involvement 
should be permitted, and that it should be left to the judgment of the 
audience as to how to evaluate the content of the program.
    While disclosure may be deemed by some in the health care 
profession a proper solution to concerns about bias, the agency's 
concerns are not wholly satisfied by disclosure. Under the act, the 
regulated industry cannot promote its products for unapproved uses, or 
otherwise promote drugs, biologics, or medical devices in ways not 
consistent with approved labeling, even in the context of unbiased 
presentations in which the company's role is fully disclosed. 
Discussions of unapproved uses, or other matters not consistent with 
approved labeling, should occur in a context of independent scientific 
or educational activity produced by organizations and individuals who 
are not involved in marketing the products. Thus, disclosure alone is 
not adequate to ensure independence in industry-supported scientific 
and educational activities as it does not insulate such activities from 
the substantive influence of supporting companies.
5. Supporting Company Involvement in Content
    The draft policy statement suggested, as part of the written 
agreement, that a company agree not to engage in scripting, targeting 
of points for emphasis, or other activities that are designed to 
influence a program's content. The draft policy statement indicated, 
however, that companies could provide ``limited technical assistance * 
* * in preparing slides or

[[Page 64086]]

audiovisual materials * * *'' (57 FR 56412 at 56413). In the final 
guidance, this discussion is included in the ``Control of Content and 
Selection of Presenters and Moderators'' factor. Although discussion 
regarding ``limited technical assistance'' is not included in the final 
guidance, as discussed in the response to comment 22 of section II.E.5. 
of this document, technical assistance is a concern.
    22. Several comments recommended that the agency more clearly 
define the limits of permissible technical assistance. Some comments 
argued that the policy should preclude all technical assistance, as to 
permit such assistance opens the door to influence. Other comments 
raised concerns that the policy is overly restrictive as to technical 
assistance in which supporting companies may engage. Several comments 
argued that supporting companies should be allowed to script, target 
points for emphasis, and provide unlimited technical assistance so long 
as such influence does not unfairly bias the program.
    The agency continues to believe that the supporting company should 
not engage in activities that could influence the presentation's 
content. Activities such as scripting and targeting points for emphasis 
can have a direct effect on the presentation's direction, balance, and 
overall message. A company-designed and financed presentation, even if 
approved by an independent provider, remains, in the agency's view, an 
activity that is not independent.
    In addition, because the agency shares the concern that technical 
assistance may open the door to influence, the agency suggests that the 
supporting company should provide limited technical support only in 
response to an unsolicited request for assistance from either the 
provider or a presenter.
6. Ancillary Promotional Activities
    The draft policy statement indicated that the written agreement 
should include an agreement by supporting companies to not have any 
promotional activities or promotional exhibits ``in the same room or in 
an obligate path to the educational activity, unless the exhibit is 
within an area that is designated for general exhibits and includes 
exhibits from different companies marketing alternative or competing 
therapies.'' Additionally, providers would agree that no advertisements 
for the supporting company's products would appear in any materials 
disseminated in the program room (57 FR 56412 at 56413). The final 
guidance states that one factor the agency will consider is whether 
there are promotional activities in the meeting room.
    23. Many comments were concerned about the scope of this element on 
ancillary promotional activities by supporting companies, specifically 
the language on promotional activities occurring in an obligate path to 
the educational activity. These comments asserted that this aspect of 
the policy was, in general, unduly restrictive; contrary to the normal 
practice of placing exhibits in advantageous locations; it would have a 
disproportionate effect on smaller, sole-sponsored, local meetings to 
the extent that it may make supporting companies reluctant to fund 
local continuing education activities; and it placed FDA, 
inappropriately, in the position of influencing meeting facility 
layout, including routes of ingress and egress into meeting facilities. 
As a consequence, the comments argued that certain facilities would 
become more or less attractive venues for educational activities on the 
basis of physical layout alone. One comment contended that the 
discussion regarding ancillary promotional activities is overly 
permissive and blurs the distinction between independence and 
promotion, which the comment viewed as contrary to the stated purpose 
of the policy. Another comment argued that the close juxtaposition of 
an independent educational activity and a promotional activity may 
sharpen rather than blur the desired distinction.
    The agency is persuaded that the language in the draft policy 
statement regarding promotional activities in an obligate path to the 
educational activity should be deleted from the final guidance. This 
provision is problematic in that its application may turn on the 
physical layout of a building, and thus may favor certain facilities 
and providers. Moreover, the agency is not convinced that this is 
necessary to preserve the distinction between an independent 
educational activity and a promotional activity. The agency gives some 
credence to one comment's observation that the close juxtaposition of 
an independent educational activity and a promotional activity may be 
as likely to sharpen as to blur the desired distinction between 
independent and promotional activities. Because its contribution to 
preserving the distinction between an independent activity and a 
promotional activity is uncertain, there is not adequate justification 
for this provision in light of its differential impact on affected 
parties. Consequently, the final guidance has been revised to suggest 
that ancillary promotional activities should not take place in the 
actual meeting room.
    24. Several comments interpreted the draft policy statement as 
precluding a sole exhibitor from having a promotional exhibit at either 
a sole or multi-sponsored educational activity. The comments objected 
that this would cause the issue to turn on whether other exhibitors 
chose to exhibit.
    These comments misinterpret the draft policy statement. The 
provision on ancillary promotion would not preclude sole exhibitors 
from exhibiting at either sole-sponsored or multi-sponsored programs. 
The final guidance, as revised, merely suggests that promotional 
activities (sole exhibitors or otherwise) not take place in the meeting 
room. Companies are otherwise free to exhibit at sole or multi-
sponsored programs without threatening the independent status of the 
activity.
7. Objectivity and Balance and Limitations on Data
    The draft policy statement contained two sections, entitled 
``Objectivity and Balance'' and ``Limitations on Data'' as part of the 
suggested written agreement. Under ``Objectivity and Balance'' a 
provider would agree to take steps to ensure that data are objectively 
selected and presented, that both favorable and unfavorable information 
about a product are fairly represented, and that there is a ``balanced 
discussion of the prevailing body of scientific information'' about a 
product and reasonable, alternative treatment options. In ``Limitations 
on Data'' the provider would agree to have ``meaningful disclosure'' of 
any limitations or uncertainty on data. Neither of these elements are 
included as factors in the final guidance.
    25. Several comments maintained that these two sections would place 
excessive regulatory burdens on providers because providers would be 
obliged to screen presentations in advance and would appear to be 
responsible for the behavior of presenters who are, to an extent, 
beyond the provider's control. Other comments argued that these 
sections are inconsistent with the concept of independence because they 
effectively regulate content in an ostensibly independent program in a 
manner similar to the fair balance requirement in FDA's advertising 
regulations. Some comments argued that these elements are necessarily 
subjective in practice and that, among other things, time limitations, 
venue, and educational objectives may influence the extent to which a 
program is considered balanced or discusses data limitations. Other

[[Page 64087]]

comments maintained that these elements state only that which should 
reasonably be expected in legitimate, independent scientific discourse 
and thus are not appropriately the subject of a regulatory policy. They 
maintained that having these elements as part of the written agreement 
is paternalistic because it does not credit the audience with the 
intelligence and means to require objectivity and balance and to put 
presented data in its appropriate context. Still other comments 
supported these elements.
    The agency is persuaded that these elements are not necessary to 
help ensure that sponsored programs are nonpromotional and independent 
of the supporting company's influence, and that there is adequate 
disclosure of relationships and information that is relevant to the 
audience's assessment of information presented. The agency is also 
persuaded that objectivity, balance, and disclosure of data limitations 
are commonly understood to be elements of typical, independent 
scientific discourse. The agency is convinced that these issues should 
be left to providers, presenters, and accreditors of educational 
activities and, therefore, these elements are not included as factors 
the agency will consider in determining independence.
8. Discussion of Unapproved Uses
    The draft policy statement suggested that if unapproved uses are 
discussed, the written agreement include an agreement by the provider 
that presenters disclose that the product is not approved in the United 
States for the use under discussion. The final guidance states that the 
agency will consider whether there is meaningful disclosure, at the 
time of the program, to the audience of whether any unapproved uses of 
products will be discussed.
    26. Several comments contended that this element is inconsistent 
with the concept of an independent program, burdensome, and would limit 
scientific exchange. Several comments added that the ultimate content 
of presentations is beyond the control of providers and that it would 
be cumbersome to flag discussion of unapproved products or uses 
throughout a program or presentation. Comments from the oncology 
community argued that this aspect of the written agreement would be 
especially burdensome for oncology educational programs because it 
would likely apply to the bulk of product uses discussed. One comment 
suggested using a general disclaimer in the program materials that not 
all products or product uses to be discussed are approved uses in the 
United States, rather than requiring presenters to specifically 
identify those unapproved uses.
    The agency is persuaded that this disclosure, as presented in the 
draft policy statement, has the potential to be burdensome and unwieldy 
in practice, particularly in specialty areas where a high percentage of 
product use is for unapproved uses. Therefore, the final guidance does 
not include as a separate factor that providers have presenters 
disclose that a particular product or use is unapproved.
    The agency, however, believes that the fact that a program may 
include discussion of products or product uses that are not approved is 
a matter that warrants disclosure. This fact, along with acknowledgment 
of the supporting company's funding of a program, is important to an 
audience's assessment of the information presented. The agency believes 
that a less burdensome disclosure than that proposed in the draft 
policy statement would suffice. The agency agrees with the comment that 
a single, general disclosure as to whether a program, or individual 
presentations in a program, will include discussion of products or 
product uses that are not approved would be adequate to address the 
agency's concern. Therefore, FDA has deleted the ``Discussion of 
Unapproved Uses'' element from the final guidance, and the factor 
discussing ``Disclosures'' has been revised to suggest that the 
provider ensure meaningful disclosure, at the time of the program, to 
the audience of whether any unapproved uses of products will be 
discussed. Ideally, such disclosure should occur in conjunction with 
disclosure of the supporting company's financial support for the 
program. This disclosure could take the form of a statement in the 
program materials or be delivered verbally at the start of the program.
    27. Several comments contended that presenters should be permitted 
to report on foreign regulatory status, and pending U.S. applications 
and supplements for products discussed.
    Nothing in this final guidance should be construed as barring 
presenters from discussing the foreign regulatory status of a product, 
or indicating that a product being discussed is the subject of a 
pending new drug application or supplement in the United States.
9. Opportunities for Debate
    The draft policy statement included an element that the provider 
agree, in the case of live presentations, to provide ``meaningful 
opportunities for scientific debate or questioning'' during the program 
(57 FR 56412 at 56414). The final guidance includes a similar factor 
entitled ``Opportunities for Discussion.''
    28. Several comments contended that it is not always practical to 
provide meaningful opportunities for debate because such opportunities 
may be contingent on the size of the program, time constraints, 
willingness of an audience to participate, and other factors unrelated 
to a program's independence. These comments maintained that an 
opportunity for debate should be a goal of an independent program, but 
not included in all activities. Other comments asked the agency to 
clarify what is meant by ``meaningful opportunities'' for debate.
    The agency agrees that opportunities for debate should be a goal of 
an independent program, but it is not practical or appropriate in all 
activities. Factors unrelated to a program's independence could 
intercede to preclude an opportunity for meaningful debate. The 
agency's inquiry concerning this factor likely would be whether a 
program format reasonably afforded an opportunity for discussion, and 
such opportunity was nonetheless not provided. This finding may suggest 
an intent to insulate from peer scrutiny the data and ideas presented. 
As with the other factors in this final guidance, a finding that a 
meaningful opportunity for discussion was denied may suggest that a 
program was not independent despite representations to the contrary.
    Certain comments seeking clarification of what is meant by a 
``meaningful opportunity for scientific debate or questioning'' seem to 
have inferred a more stringent concept than was intended. The goal 
contemplated is no more than a reasonable opportunity for the type of 
question and answer session typical of continuing education activities. 
The agency has changed the word ``debate'' to ``discussion'' to reflect 
this less structured intent.
10. Schedule of Activities
    The draft policy statement suggested that the company and provider 
agree to, and record in the written agreement, the dates, times, and 
locations of all presentations (57 FR 56412 at 56414).
    29. Several comments contended that it is overly burdensome to have 
a supporting company and provider identify all presentations to be 
held. They maintained that this is problematic in that not all future 
programs may be anticipated at the time a provider and supporting 
company enter into an arrangement. Several comments maintained that the 
fact of multiple presentations of the same program should not be viewed 
as

[[Page 64088]]

suggesting possible promotional intent so as to warrant higher 
scrutiny. Some comments argued that it is desirable to repeat certain 
programs for public health reasons, that demand for additional programs 
suggests that a program is valuable, and that repeat presentations are 
desirable as they are the most efficient way to disseminate valuable 
information. Some comments contended that there should be a distinction 
between multiple programs that were agreed to in advance of any 
presentation and those that were agreed to after the fact, and only the 
later should be subject to higher scrutiny.
    The agency is convinced that it may be difficult for a supporting 
company and provider to document the dates, times, and locations of all 
presentations in advance and, therefore, has removed this element from 
the final guidance. The agency, however, remains convinced that, in 
some circumstances, the fact of multiple presentations may be an 
indicator of supporting company influence. The agency agrees that 
multiple presentations of the same program are more troublesome when a 
supporting company agrees to fund additional programs after having 
viewed the initial program. This opportunity to view a program in 
advance of a decision to fund additional programs provides an obvious 
degree of control over content of multiple presentations. Thus, these 
programs would be viewed with greater scrutiny.

F. Other Factors in Determining Independence

    The draft policy statement stated that if, notwithstanding the 
presence of a written agreement, a question is raised regarding product 
promotion, FDA would consider several ``possible indicia of company 
influence.'' These factors included, among others, an examination of 
the relationship between the provider and supporting company, the 
provider's involvement in the company's sales or marketing, logistical 
assistance provided by the company, the program's focus (whether the 
program concentrated on a single product), and gifts to encourage 
attendance (57 FR 56412 at 56414). The draft policy statement also 
indicated that ``no individual factor is likely by itself to stimulate 
an action based on lack of independence.'' Many of the factors that 
were discussed in the ``Other Factors in Determining Independence'' 
section of the draft policy statement (section II.B.) have been 
retained in the final guidance.
    30. Several comments advised deleting this entire section from the 
policy. Another comment contended that the articulated factors undercut 
the protection afforded by the policy by permitting post hoc review of 
a provider's decisions for indications of possible influence.
    The agency believes that it is important to consider the actual 
conduct of the parties in determining whether a supporting company has 
acted to transform an educational activity into a promotional 
presentation for its products. By including this discussion in the 
``Factors Considered in Evaluating Activities and Determining 
Independence'' (section A. of the final guidance), the agency believes 
that there will be less concern regarding post hoc review.
1. Relationship Between Provider and Supporting Company
    The draft policy statement noted that legal, business, or other 
relationships between the company and the provider might place the 
company in a position whereby it could influence the content of the 
activity. This discussion is contained in the final guidance as a 
factor the agency will consider.
    31. Some comments contended that there should be clarification of 
the types of relationships that predispose a supporting company to 
influence content. Some comments argued that ``influence'' is too 
expansive or vague a term, and that, a more appropriate inquiry would 
be supporting company ``control.''
    As discussed in response to comment 14 of section II.E. of this 
document, a company-designed presentation does not become independent 
merely because it is approved by a provider who has final editorial 
control. The agency believes that ``influence'' is the most appropriate 
term to describe the basic concept of independence. The final guidance 
does, however, identify several types of relationships that may 
predispose a supporting company to influence content (e.g., legal 
relationships, business relationships, a provider that is owned by, or 
is not viable without the support of the supporting company).
    32. One comment contended that legal, business, or other 
relationships should not be at issue where ``a provider has documented 
independence through accreditation from a major accrediting 
organization.''
    There is no basis for assuming that accreditation of the provider 
by a major accrediting organization will, in and of itself, ensure that 
the provider will not be subject to influence as a result of a 
relationship with the supporting company.
2. Provider Involvement in Sales or Marketing
    The draft policy statement listed, as another factor in determining 
independence, the provider's involvement in advising or assisting in 
the sales or marketing of a company's product. The discussion in the 
draft policy statement stating that ``individuals who are involved in 
promotion of a company's products may not function in the role of 
independent provider, but could be selected by an independent provider 
to function as a speaker or moderator'' (57 FR 56412 at 56414) has been 
deleted. The remaining discussion is listed in the final guidance as a 
factor the agency will consider.
    33. Some comments identified situations where this provision may be 
interpreted so as to preclude institutional providers and/or companies 
from interacting due to minor or unrelated involvement with the 
supporting company.
    The primary concern of the agency, as reflected in the draft policy 
statement, is with relationships that may affect the provider's 
independence. A relationship between a provider member or employee and 
a supporting company will not, in and of itself, imply influence by the 
company. If, however, company employees or individuals acting on behalf 
of the company are actively involved in provider decisions on the 
content of provider activities sponsored by the company, there may be a 
reason to question the provider's independence.
    34. Some comments contended that this provision does not adequately 
distinguish between advertising agencies involved in sales and 
advertising, and communications companies involved in education, which 
also may be viewed as a marketing function, nor does it allow for the 
existence of advertising and communications (or education) divisions 
within the same company.
    FDA acknowledges that certain providers are often involved in both 
promotional activities and independent educational activities. The 
involvement of a provider in both types of activities does, however, 
raise questions about whether an educational activity is, in fact, 
being utilized as part of a promotional campaign.
    While the final guidance does not preclude the use of the same 
provider in a promotional effort and an independent educational 
activity, such an arrangement poses obvious difficulties. Companies 
choosing to engage a provider in both activities should be especially 
concerned about the

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assignment of provider personnel to the different activities. The 
agency will not ordinarily regard provider personnel who serve as 
company agents for company promotional activities to be independent for 
other company-sponsored scientific or educational activities.
3. Provider's Demonstrated Failure to Meet Standards
    The draft policy statement identified, as a factor in determining 
independence, the provider's record of failure to meet standards of 
independence, balance, objectivity, or scientific rigor when putting on 
ostensibly independent educational programs (57 FR 56412 at 56414). 
This discussion is listed in the final guidance as a factor the agency 
will consider.
    35. Some comments sought clarification as to what is meant by, or 
what criteria support a conclusion of, ``demonstrated failure to meet 
standards'' on the part of a provider. Some comments contended that 
this is an unworkable requirement as supporting companies are not in a 
position to know of a provider's past failures to meet standards in its 
educational programs.
    It is not unreasonable to expect due diligence on the part of 
companies when contracting with providers. In exercising due diligence, 
supporting companies should conduct a reasonable evaluation of all 
information readily available about a provider.
4. Logistical Assistance
    Another factor in determining independence contained in the draft 
policy statement was the extent of logistical assistance provided by 
the supporting company. The draft policy statement specifically 
mentioned that ``significant contact'' between industry representatives 
and presenters might indicate an attempt to influence a presentation 
(57 FR 56412 at 56414). As discussed in comment 36 of section II.F.4. 
of this document, this discussion has been deleted from the final 
guidance.
    36. Several comments argued that the logistical assistance element 
was too ambiguous a standard as it is not clear what is meant by 
``significant contact.'' Some comments argued that, notwithstanding any 
ambiguity, significant contact between a presenter and a supporting 
company representative should not be an indicator of influence as the 
agency's inquiry should focus on actual attempts to influence or 
control the content of a presentation. They maintained that supporting 
company representatives have ongoing relationships with presenters that 
would make compliance with a generalized ``significant contact'' 
standard problematic.
    While the agency believes that the ``significant contact'' standard 
is amenable to clarification, it need not be, as the agency is 
persuaded that its inquiry concerning contacts between a presenter and 
a supporting company in conjunction with a sponsored program should 
focus on attempts to influence, rather than on volume or nature of 
contacts. A supporting company, among other factors for determining 
independence, should not script, target points for emphasis, or engage 
in other activities that are designed to influence the content of a 
program. The agency believes that factor alone is adequate to address 
the agency's concern as to contact between a supporting company 
representative and a presenter in conjunction with a sponsored program. 
Therefore, discussion of the logistical assistance provision has been 
deleted from the final guidance.
5. Suggestion of Presenters
    The draft policy statement acknowledged that some providers 
perceive a need to ask the supporting company to suggest presenters. 
The draft policy statement stated that if a company suggests presenters 
who ``are or were actively involved in promoting the company's products 
or who have been the subject of complaints or objections with regard to 
presentations that were viewed as misleading or biased in favor of the 
company's products,'' FDA might infer promotional intent on the 
company's part (57 FR 56412 at 56414). This discussion has been 
incorporated, in part, into the factor concerning ``Control of Content 
and Selection of Presenters and Moderators'' in the final guidance.
    37. Some comments contended that a supporting company may not be in 
a position to know if a presenter it suggests has been the subject of 
complaints with regard to presentations viewed as biased in favor of 
the company's products. They maintained that this provision should 
expressly indicate that supporting companies are only accountable for 
knowingly suggesting presenters that have been the subject of such 
complaints.
    The agency believes that the company should be familiar with the 
presenter's background and should be willing to make a reasonable 
inquiry before recommending the name of a presenter to the provider. In 
the final guidance, this discussion has been incorporated in the factor 
concerning ``Control of Content and Selection of Presenters and 
Moderators.''
    38. Some comments contended that there should be no inference of 
promotional intent arising from a supporting company's suggestion of a 
presenter who has been involved in promoting a company's products. They 
argued that actual influence of, rather than intent to influence, an 
activity is the relevant inquiry, that the scope of activities that may 
be viewed as involvement in product promotion is unclear, and that any 
relationship between the presenter and the supporting company can be 
adequately addressed through disclosure.
    The agency is concerned about the ability of a supporting company 
to hire an individual to engage in promotional activities for the 
company and to actively support the appearance of the same individual 
as a presenter in an independent educational activity sponsored by the 
company. The agency does not agree that a retrospective finding of 
actual influence, which may be extremely difficult to document, is the 
relevant inquiry. The issue is whether the company is in a position to 
influence program content by suggesting a presenter who is a paid 
product promoter. The suggestion by supporting companies of presenters 
selected from their company maintained list and/or their marketing 
consultants may be viewed as an attempt to influence the content of the 
program. The agency will not ordinarily infer such intent when a 
provider independently selects a presenter who has been involved in 
product promotion for a supporting company. Disclosure cannot overcome 
the lack of independence that will ordinarily result from companies 
suggesting promoters as presenters in such programs.
6. Focus on a Single Product
    The draft policy statement indicated that one factor in determining 
independence might be whether the program content was focused on a 
single product marketed by the supporting company or a competing 
product except when existing treatment options were so limited as to 
preclude any meaningful discussion of alternative therapies. The draft 
policy statement noted that each treatment option did not have to be 
discussed with equal emphasis, but that emphasis on newer or more 
beneficial treatments should be provided ``in the context of a 
discussion of all reasonable and relevant options'' (57 FR 56412 at 
56414). This discussion has been incorporated in the factor concerning 
the ``Focus of the Program'' in the final guidance.

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    39. Some comments contended that focus on a single product should 
not be regarded as a factor that may suggest lack of independence, as 
single product programs are useful, especially during a product's 
launch phase, and choice of topic should be at the provider's 
discretion and should confer no negative inference.
    FDA agrees that single product programs may be useful, especially 
during a product's launch phase. However, the agency also recognizes 
that single-product programs raise unique concerns about the 
independence of a program, because such programs inherently lack the 
presentation of competing therapeutic modalities.
    40. Several comments contended that to suggest that a program 
emphasizing a single product do so in the context of a discussion of 
all reasonable and relevant options is unreasonable or impossible given 
the time constraints of a typical educational activity.
    The final guidance does not suggest that a program emphasizing a 
single product do so in the context of a discussion of all reasonable 
and relevant options. However, the agency will consider, as one of 
several factors, a program's focus on a particular therapy when other 
reasonable and relevant options are either not discussed or are de-
emphasized.
7. Multiple Presentations
    The draft policy statement indicated that multiple performances of 
the same program might result in a higher level of agency scrutiny than 
single-performance programs (57 FR 56412 at 56414). The final guidance 
states that the agency will consider whether multiple presentations of 
the same program are held.
    41. Several comments contended that multiple presentations should 
not be viewed as suggesting promotional intent so as to warrant higher 
scrutiny. They argued that it is desirable to repeat certain programs 
for public health reasons, that the demand for multiple programs 
suggests that a program is a valuable one, and that repeat 
presentations are desirable as they are the most efficient way to 
disseminate valuable information. Some comments contended that there 
should be a distinction between multiple programs that were agreed to 
before the fact and those that were scheduled after the fact. They 
contended that only the latter should be subject to a higher level of 
scrutiny.
    Multiple presentations are just one of a number of factors the 
agency considers in determining the level of scrutiny to be applied. 
Footnote 4 of the draft policy statement explicitly recognized that 
repeat presentations can serve public health interests and that Public 
Health Service components sometimes actively encourage multiple 
presentations on selected urgent topics. FDA agrees that an agreement 
to conduct multiple presentations arrived at prior to commencement of 
the initial presentation raises fewer questions than an agreement 
arrived at after commencement. The opportunity of a sponsor to view the 
initial presentation before agreeing to fund additional presentations 
provides an obvious degree of control over content of multiple 
presentations.
    42. Some comments sought clarification of the scope of activities 
that may be deemed multiple presentations. The comments described 
examples such as a single broadcast to multiple sites via electronic 
media, and a multiple presentation at a single location for the purpose 
of accommodating several nursing shifts.
    A single broadcast to multiple sites would be regarded as a single 
presentation because the sponsoring company could not apply added 
control to the additional sites. Thus, the presentation at each site 
enjoys an equal degree of independence. This is only slightly less true 
for multiple presentations to accommodate several shifts on the same 
day, especially when the multiple presentations have been contracted 
for in advance. Of course, the delay might be 1 or 2 weeks to 
accommodate those who might have been on a different rotation or 1 or 2 
months to accommodate newly hired employees. FDA believes that any 
increased opportunity for a sponsoring company to deny funding for 
subsequent presentations or to edit them will raise a question with 
regard to independence.
8. Gifts
    The draft policy statement indicated that one factor in determining 
independence might be gifts or inducements (other than token gifts) 
provided to encourage attendance (57 FR 56412 at 56414). The final 
guidance does not contain this factor.
    43. One comment argued that this provision should be deleted 
because it merely duplicates the Accreditation Council for Continuing 
Medical Education (ACCME) guidelines.
    ACCME-accredited programs do not represent the full range of 
activities to which this final guidance applies, and moreover, 
providers of ACCME-accredited programs may not, in all instances, 
comply with ACCME-guidelines. Nonetheless, this factor has been deleted 
from the final guidance because, upon reconsideration, the agency is 
not convinced that the use of gifts or inducements to encourage 
attendance is a reliable factor in determining independence.
9. Emphasis on Noneducational Activities
    The draft policy statement indicated that an emphasis on 
noneducational activities (such as leisure or recreational activities) 
would be another factor in determining independence (57 FR 56412 at 
56414). The final guidance does not contain this factor.
    44. Some comments contended that the agency's concern over whether 
the announcement and promotion of an educational activity focuses more 
on the educational content than on leisure or recreational activities 
ancillary to the activity is vague and that the agency should provide 
objective criteria for assessing this issue. One comment contended that 
this provision appears to create a weaker standard than that of the AMA 
guidelines on gifts to physicians as it seems to indicate that a 
program announcement or promotion that focuses equally on education and 
leisure would be appropriate. They urged that the language be changed 
to require that the program announcement and promotion focus 
``predominantly'' or ``almost exclusively'' on the educational aspects 
of the program.
    The agency continues to view the AMA guidelines as an appropriate 
standard for health care professionals. Although the agency agrees that 
program promotion, including program announcements, should focus 
predominantly on the educational content of the program, it does not 
consider greater focus on leisure or recreational activities as reason 
to believe that the program may be lacking independence.
10. Audience Selection
    Under the draft policy statement, another factor in determining 
independence was whether the supporting company's sales or marketing 
departments generated the invitation or mailing lists for supported 
activities, or whether such lists were intended to reflect sales or 
marketing goals (such as rewards for high prescribers of the company's 
products or to influence ``opinion leaders'') (57 FR 56412 at 56414). 
This discussion is listed in the final guidance as a factor the agency 
will consider.
    45. Several comments objected to limitations on supporting company 
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generating audiences for educational activities. Some maintained that 
supporting company-generated mailing lists should be permitted. Some 
maintained that providers should be permitted to enlist the aid of the 
supporting company's sales representatives to generate audiences by 
distributing program invitations, or by other means, and that this 
involvement should not suggest a lack of independence unless a 
supporting company is solely responsible for generating an audience.
    The agency continues to view company involvement in audience 
selection and/or solicitation for attendance as undermining program 
independence. The involvement of company sales representatives in the 
invitation process creates an opportunity for a sales presentation on 
the product that is likely to be discussed at the program. This may 
invite a discussion of unapproved uses in a promotional context, thus 
making the educational program a part of the company's promotional 
campaign. In addition, supporting company involvement in the audience 
selection process invites the development of lists that target health 
care professionals who are deemed important to attend by the supporting 
company. It also invites the selection of a large number of ``peer 
influence'' professionals who are likely to be strong supporters of the 
company's products. This provides an opportunity for bias and indirect 
influence on the content of the program, and it allows the program to 
be used as a promotional vehicle for targeted health care 
professionals.
    46. Some comments contended that the selection of ``opinion 
leaders'' as a target audience should not raise an issue inasmuch as 
such physicians are deemed important by genuinely independent providers 
as well as companies. They argued that opinion leaders are likely the 
most efficient purveyors of information derived from educational 
activities that, by their very nature, are accessible to only a limited 
number of physicians.
    The focus on opinion leaders is a standard promotional tactic to 
speed acceptance of a new product so as to more rapidly increase market 
share. The agency's understanding of educational needs assessments by 
providers is that educational programs generally are not directed to 
specific opinion leaders. It is the agency's understanding that there 
is no such policy on the part of major accrediting organizations such 
as ACCME. It is reasonable to question whether a program that targets 
``opinion leaders'' may do so for promotional purposes. This inference 
of possible promotion, however, is only one of many factors to be 
considered should a question be raised concerning an educational 
activity purported to be independent.
    47. One comment contended that supporting companies should be 
permitted to furnish providers with complete specialty and subspecialty 
mailing lists.
    The agency would not object to a supporting company furnishing a 
provider with complete specialty or subspecialty mailing lists.
11. Misleading Title
    The draft policy statement indicated that a program's title might 
demonstrate a lack of independence if the title failed to fairly 
represent the scope of the presentation (57 FR 56412 at 56414). This 
discussion has been incorporated in the factor concerning the ``Focus 
of the Program'' in the final guidance.
    48. One comment argued that, where the title is under the direction 
and control of the provider, it is not the proper subject of a 
promotional inference as to the supporting company.
    Although the title of a program may ostensibly be under the 
direction and control of the provider, the agency has observed that a 
misleading title may reflect a lack of independence and a desire on the 
part of the provider to promote the supporting company's products under 
the guise of education. For example, a program entitled ``New 
Approaches to Hypertension'' that focuses on a single product 
manufactured by the sponsoring company may suggest to the agency that 
the program is designed to promote the company's product. A misleading 
title is not, in and of itself, dispositive with regard to the issue of 
promotional intent. It is only one of a number of factors to be 
considered by the agency.
12. Dissemination
    Under the draft policy statement, if information about the 
supporting company's product presented in the scientific or educational 
activity is further disseminated after the initial program or 
publication, by or at the company's behest, other than in response to 
an unsolicited request or through an independent provider, this would 
be another indication of possible company influence (57 FR 56412 at 
56414). This discussion has been incorporated into the final guidance 
as a factor the agency will consider.
    49. Some comments maintained that the independence of an 
educational activity is enduring and that the public health is better 
served by making written, printed, or graphic program materials readily 
available to health care professionals.
    Written, printed, or graphic materials containing product 
information and disseminated by, or on behalf of, a product 
manufacturer are generally viewed as promotional labeling. If, on the 
other hand, the materials are prepared and disseminated by the provider 
for educational purposes, or the materials are disseminated by the 
company in response to an unsolicited request, this would not generally 
be considered as a possible indication of company influence.
    50. One comment contended that footnote 6 of the draft policy 
statement (which noted that repeat performances are permitted when the 
decision is made by the provider, possibly with review by a nationally 
recognized professional organization) should be deleted, as it appears 
to be more restrictive for repeat presentations than other provisions 
in the draft policy statement.
    The agency believes that footnote 6 of the draft policy statement 
is consistent with other provisions of the draft policy statement. As 
suggested in the text of the draft policy statement, multiple 
performances may cause the agency to exercise greater scrutiny. 
However, a decision made by the provider that multiple presentations 
are warranted provides some assurance that there is a genuine 
professional need for repetition of the program. Nevertheless, FDA no 
longer believes that this footnote is necessary and has deleted it from 
the final guidance.
    51. One comment suggested that the reference to ``publication'' in 
section II.B.5 of the draft policy statement be struck as this appears 
not relevant to the range of activities contemplated by the policy.
    FDA agrees with the comment and has removed the reference to 
``publication'' from the final guidance.
13. Complaints
    Another factor for determining independence under the draft policy 
statement concerned complaints from the provider, presenters, or 
attendees regarding attempts by the company to influence content (57 FR 
56412 at 56414). This discussion has been incorporated into the final 
guidance as a factor the agency will consider.
    52. Some comments contended that complaints should be independently 
substantiated before becoming a basis for the agency inferring 
promotional intent and that the agency should clarify the mechanism for 
reporting complaints.

[[Page 64092]]

    In general, the agency will not infer promotional intent by a 
supporting company without an investigation that substantiates, to the 
agency's satisfaction, a complaint or allegation.
    The agency declines to establish a formal mechanism for reporting 
complaints. FDA receives information through various means, both formal 
(as in requests for meetings) and informal (such as letters and 
telephone calls). The agency will exercise its judgment and discretion 
in deciding whether to take action on a complaint.

G. FDA Reliance on Major Accrediting Organizations

    The draft policy statement acknowledged that accrediting 
organizations can play an important role in ensuring that industry-
sponsored activities are independent and nonpromotional. The draft 
policy statement indicated that FDA would seek to rely to the extent 
possible on major accrediting organizations to monitor company-
supported educational activities conducted by their accredited 
providers (57 FR 56412 at 56414). In the final guidance, this section 
has been renamed ``FDA's Cooperation With Major Accrediting 
Organizations'' and it states that the agency will continue to work 
with major accrediting organizations to monitor company-supported 
educational activities conducted by their accredited providers.
    53. Some comments questioned the extent of FDA's intent to rely on, 
and to defer to, major accrediting organizations.
    Although FDA recognizes the valuable role that accrediting 
organizations can play in ensuring that industry-supported educational 
activities are independent and nonpromotional, FDA cannot rely 
exclusively on such organizations. The ultimate responsibility for 
monitoring inappropriate promotion in these programs lies with FDA. 
Accordingly, the final guidance has been revised to clarify that FDA 
intends to work with major accrediting organizations to monitor 
company-supported educational activities conducted by their accredited 
providers.

III. Comments

    Interested persons may, at any time, submit written comments to the 
Dockets Management Branch (address above). Requests and comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments may be submitted at any time and will be 
used to determine whether to revise the guidance further.

    Dated: November 24, 1997.
William B. Schultz,
Deputy Commissioner for Policy.

    The text of the final guidance follows:

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[FR Doc. 97-31741 Filed 12-2-97; 8:45 am]
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