[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Notices]
[Pages 24314-24316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12022]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0227]
Direct-to-Consumer Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a notice
making clear that the agency does not require preclearance of
prescription product promotion (advertising and promotional labeling)
of human or animal drugs, biologics, or restricted medical devices
directed toward consumers. FDA is also requesting comments on its
intent to consider certain FDA-approved patient labeling as adequate to
fulfill the brief summary requirement in consumer-directed
advertisements. Finally, FDA is soliciting comments concerning several
issues related to consumer-directed promotion of prescription
biologics, human and animal drugs, and restricted medical devices to
help guide policy decisions.
DATES: Written comments by August 12, 1996.
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: Nancy M. Ostrove, Division of Drug
Marketing, Advertising and Communications (HFD-40), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, rm. 17-B04, Rockville, MD 20857, 301-827-2828, or via Internet at
O[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under the Federal Food, Drug, and Cosmetic Act (act) and the Public
Health Service Act, the Food and Drug Administration (FDA) has
responsibility for regulating the labeling and advertising of
prescription drugs (animal and human), biologics, and restricted
medical devices. Labeling and advertising must follow certain
requirements, as defined by the Act and implementing regulations.
Under section 502(n)of the act (21 U.S.C. 352(n)), an advertisement
for a prescription drug must contain, in addition to the product's
established name and quantitative composition, ``such other information
in brief summary relating to side effects, contraindications, and
effectiveness * * *.'' This requirement is further defined in
prescription drug advertising regulations at Sec. 202.1(e) (21 CFR
202.1(e)). Under section 502(r) of the act (21 U.S.C. 352(r)), an
advertisement for a restricted medical device must contain, in addition
to the established name, ``a brief statement of the intended uses of
the device and relevant warnings, precautions, side effects, and
contraindications * * *.''
The act and FDA's advertising regulations do not distinguish
between targeted audiences. FDA recognizes, however, that there are
differences between the information needs of health care professionals
and consumers resulting from differences in medical and pharmaceutical
expertise, and differences in roles as potential recipients of
medications or prescribers of medications, that may affect their
perceptions, comprehension, and interpretation of promotional claims.
In light of these differences, FDA is continuing to evaluate its
policies and regulations.
In the Federal Register of August 16, 1995 (60 FR 42581), FDA
announced a part 15 (21 CFR part 15) hearing to be held on October 18
and 19, 1995. In that document, the agency solicited oral testimony and
written responses to a series of questions concerning direct-to-
consumer (DTC) promotion of prescription drugs. At the hearing, the
agency heard testimony from representatives of consumer and patient
groups, advertising associations, and foreign governments, as well as
from individual academicians, attorneys, marketers, and pharmaceutical
manufacturers. The agency accepted written comments until December 29,
1995. FDA is currently evaluating the testimony, comments, and issues
raised by both the public hearing and citizen petitions submitted prior
to the hearing.
While this evaluation proceeds, FDA is providing clarification of
two of its policies and soliciting additional information to help in
the development of overall policy. FDA views these efforts as part of a
comprehensive process designed to encourage meaningful communication to
consumers about prescription drugs, biologics, and restricted medical
devices, while continuing to help ensure that consumers are adequately
protected from false, misleading or otherwise violative promotion.
II. Preclearance
One issue raised in oral testimony, written comments, and citizen
petitions was an objection to the perceived requirement for
manufacturers to obtain prior clearance from the agency for all
prescription drug and biological DTC promotion. There is, in fact, no
such requirement. Given public and congressional concern since the
early 1980's about prescription drug DTC promotion, together with the
inexperience of the pharmaceutical industry in producing DTC
advertising, FDA had informally requested manufacturers to submit, on a
voluntary basis, proposed DTC promotional
[[Page 24315]]
labeling and advertising for review and comment prior to use. See
Sec. 202.1(j)(4), which provides that ``any advertisement may be
submitted to the Food and Drug Administration prior to publication for
comment.''
FDA wishes to clarify that it has never required preclearance of
consumer-directed prescription drug promotion, or advertising for
restricted devices. Under sections 502(n) and 502(r) of the act, FDA
may require prior approval of prescription drug and medical device
advertisements only in ``extraordinary circumstances.'' (See, e.g.,
Sec. 202.1(j)(1)--prior approval will be required when a sponsor or FDA
receives information, not widely publicized in medical literature, that
a drug may cause fatalities or serious injuries, and despite
notification from FDA, the sponsor fails to publicize adequately such
information.)
FDA believes that industry's desire for agency guidance on proposed
DTC promotion and applicable regulatory requirements, and the cost of
developing corrective materials or campaigns explains the high rate of
submission of DTC promotional materials for prior review and comment.
However, it appears that the agency's request that manufacturers
voluntarily obtain advice on proposed DTC materials has been
misinterpreted as a requirement. FDA reiterates that it does not now
require, nor has it ever required, manufacturers to submit DTC
promotional labeling and advertising for preclearance. \1\
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\1\ This does not apply to submissions required in a premarket
notification submission or premarket approval application (PMA)
under 21 CFR 807.87(e) and 814.20(b)(10) or submissions required in
connection with accelerated approval under 21 CFR 314.550 and
601.45.
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III. Patient Labeling in Fulfillment of the ``Brief Summary''
Requirement
FDA recognizes that many consumers do not have the technical
background to understand fully the information typically included in
prescription drug and biological advertisements to fulfill the ``brief
summary'' requirement. To meet the ``brief summary'' requirement,
sponsors typically reprint, in small type, whole sections of the
professional labeling, which is generally written in terms that are not
easily understood by the average consumer.
Some prescription drugs and biological products have FDA-approved
labeling, in addition to that written for health professionals, that
contains information intended to be understandable to patients. This
patient labeling contains information that comprehensively, although
not exhaustively, describes the safety and efficacy of the product.
Although it is less comprehensive than professional labeling, patient
labeling is intended to provide patients prescribed the medication with
information that will help them use their medication effectively and
safely. It should also, therefore, provide potential users with
appropriately written product information they may want to consider.
FDA believes that such FDA-approved patient labeling generally
meets the brief summary requirements, and, because it is written for
patients, is a more appropriate vehicle for communicating risk
information to consumers than the technically-written brief summary.
FDA is requesting comment on its intention to consider the reprinting
of certain FDA-approved patient labeling as adequate to fulfill the
brief summary requirement in consumer-directed advertisements for
prescription drug and biological products. The following products offer
prototypical examples of such comprehensive patient labeling: Oral
contraceptives, estrogenic products, Cardura,
Fosamax, Glucophage, Hytrin,
Proscar, Seldane, and Ticlid.
Not all FDA-approved patient labeling, however, generally meets the
brief summary requirements. Some approved patient labeling primarily is
intended to give instructions for use (e.g., directions on how to use
medications delivered via inhalation, nasal spray, patch, or
injection). Other patient labeling focuses primarily on a single
warning (e.g., Accutane , the class auxiliary warning labels
on angiotensin-converting-enzyme (ACE) inhibitors and isoproterenol
inhalers). In both of these instances, the patient labeling has a
narrow focus that is not intended to offer comprehensive risk
information to patients. Because of this narrow focus, such patient
labeling would not generally meet the brief summary requirements and
would not be considered acceptable consumer brief summaries.
FDA also notes that many manufacturers have voluntarily produced
informational brochures and other product-specific materials for
patients that are disseminated through various outlets. These materials
are typically submitted to the agency either for prior review and
comment, or through the postmarketing review process specified in 21
CFR 314.81(b)(3)(i). Such materials that have not been through the
formal labeling review process should not be considered automatically
acceptable as a consumer brief summary. Instead, they may be used as
brief summaries only if they fulfill all of the applicable requirements
in Sec. 202.1(e).
IV. Requests for Comments on Other Issues
Many complex public health issues are raised by DTC promotion. In
the August 16, 1995, Federal Register document, FDA solicited broad
public comment on the major issues concerning DTC promotion and whether
the agency's current regulatory approach should be modified. Some of
these issues were specifically addressed in testimony and written
comments. These raised additional questions, about which FDA is now
soliciting public comment.
1. -Currently, Sec. 202.1(e) states that the brief summary shall
include information relating to side effects, warnings, precautions,
contraindications, and other risk information. In print advertising,
this requirement is generally fulfilled by including the risk-related
sections of the approved labeling in, or adjacent to, the
advertisement. For advertisements broadcast through media such as
radio, television, and telephone communications systems,
Sec. 202.1(e)(1) provides that the advertisement ``shall include
information relating to the major side effects and contraindications of
the advertised drugs in the audio or audio and visual parts of the
presentation and unless adequate provision is made for dissemination of
the approved or permitted package labeling in connection with the
broadcast presentation shall contain a brief summary of all necessary
information related to side effects and contraindications.''
In addition, section 502(r) of the act requires that advertisements
for restricted devices contain a brief statement of the intended uses
of the device and relevant warnings, precautions, side effects, and
contraindications.
Much testimony, petitions, and comments questioned the usefulness,
for consumers, of the existing ``brief summary'' of risk information
that results from application of these requirements. Many comments
contended that, for consumer advertising, a shorter, more focused
presentation of user-friendly information could meet the statutory
requirement and also provide appropriate risk-related information. Some
comments suggested that a consumer brief summary should include
``information relating to the major side effects and
contraindications'' of the product, as currently required in
prescription drug and biological product
[[Page 24316]]
broadcast advertising. (This information has colloquially been referred
to as the ``major statement.'')
If FDA required or permitted more limited risk information in place
of the current brief summary, what specific information should be
included? What criteria should be used by manufacturers and the agency
to identify the ``major'' risk information for any particular product?
FDA is also interested in empirical research that specifically
addresses the issues of how much and what kind of risk information can
and should be communicated in DTC advertising of prescription drug and
biological products.
2. Some comments suggested that risk information could be
communicated to consumers through standardized general disclosures.
This kind of disclosure would not reference particular characteristics
of a product. Instead, such statements would reference one or more
general risks, such as the fact that all prescription drug and
biological products have side effects; that they are only available
from a physician or other prescribing health care professional; that
they have significant benefits, but may have significant risks; that
patients should discuss product risks with a physician, etc.
Such disclosures, however, are susceptible to habituation or
``wear-out,'' which results in the viewer quickly learning to ignore
the message, thus lowering its effectiveness. In addition, such
messages may not be perceived as risk messages at all, but instead
interpreted as reassurances. If the latter is the case, these messages
would not fulfill the purpose of the brief summary requirement, which
helps ensure that advertising conveys a balanced impression about the
product's benefits and risks.
FDA solicits comments on the effectiveness of such standardized
general disclosures at transmitting risk information. FDA is especially
interested in any research that addresses the issue of the
effectiveness of general risk disclosures of the type described above.
3. Promotional materials appear in very different media that each
have distinctive characteristics (e.g., print, broadcast, telephone
communications, facsimile, Internet). Should FDA require or permit
different disclosures for consumer-directed promotion of prescription
drug and biological products that appears in different media, to
reflect the capabilities of these varying media, or should the
disclosure be the same regardless of medium? For example, should print
media contain longer and more complete information than broadcast media
because such information could be made readily available at minimal
cost and because consumers of print media may be more willing, able,
and/or desirous of obtaining more complete information?
4. Different products have different degrees of effectiveness. In
some cases, a product that works for a relatively small percentage of
the appropriate patient population is approved either because it is the
only available therapy for a condition; because all other therapies for
the condition also have only modest benefits; or because it has
relatively few risks. Should FDA require the communication of the
degree of product effectiveness in DTC promotion? How could this
information be communicated most effectively?
5. It has been suggested that toll-free telephone numbers are one
way that product sponsors could make required information available to
audiences. FDA requests comments and information from consumers, health
professionals, product sponsors and other interested individuals
regarding: (a) How useful toll-free numbers are as a mechanism for
obtaining or disseminating information about medical products, and (b)
the costs to a sponsor of using toll-free numbers as a means of
disseminating information.
FDA welcomes comments on all of the issues described above and
especially invites the submission of relevant empirical research.
Dated: May 8, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-12022 Filed 5-13-96; 8:45 am]
BILLING CODE 4160-01-F