[Federal Register Volume 75, Number 59 (Monday, March 29, 2010)]
[Proposed Rules]
[Pages 15376-15387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6996]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 202

[Docket No. FDA-2009-N-0582]
RIN 0910-AG27


Direct-to-Consumer Prescription Drug Advertisements; Presentation 
of the Major Statement in Television and Radio Advertisements in a 
Clear, Conspicuous, and Neutral Manner

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations concerning direct-to-consumer (DTC) advertisements of 
prescription drugs. Specifically, the proposed rule would implement a 
new requirement of the Federal Food, Drug, and Cosmetic Act (the act), 
added by the Food and Drug Administration Amendments Act of 2007 
(FDAAA), that the major statement in DTC television or radio 
advertisements (or ads) relating to the side effects and 
contraindications of an advertised prescription drug intended for use 
by humans be presented in a clear, conspicuous, and neutral manner. FDA 
is also proposing, as directed by FDAAA, standards that the agency 
would consider in determining whether the major statement in these 
advertisements is presented in the manner required by FDAAA.

DATES:  Submit written or electronic comments on the proposed rule by 
June 28, 2010. Submit comments on information collection issues under 
the Paperwork Reduction Act of 1995 by April 28, 2010, (see section 
``VI. Paperwork Reduction Act of 1995'' of this document). See section 
II.D of this document for the proposed effective date of a final rule 
based on this proposed rule.

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2009-
N-0582 and/or RIN 0910-AG27, by any of the following methods, except 
that comments on information collection issues under the Paperwork 
Reduction Act of 1995 must be submitted to the Office of Regulatory 
Affairs, Office of Management and Budget (OMB) (see the ``Paperwork 
Reduction Act of 1995'' section of this document).
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency 
name, docket number, and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.
    The information collection provisions of this proposed rule have 
been submitted to OMB for review. Interested persons are requested to 
fax comments regarding information collection by April 28, 2010, to the 
Office of Information and Regulatory Affairs, OMB. To ensure that 
comments on information collection are received, OMB recommends that 
written comments be faxed to the Office of Information and Regulatory 
Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to 
oira_submission@omb.eop.gov.

FOR FURTHER INFORMATION CONTACT:
For information concerning human drug products: Marissa Chaet Brykman, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 51, rm. 3238, Silver Spring, MD, 20993-
0002, 301-796-1200; or
For information concerning human biological products: Stephen Ripley, 
Center for Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD, 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 502(n) of the act (21 U.S.C. 352(n)) requires that 
manufacturers, packers, and distributors (sponsors) who advertise 
prescription human and animal drugs, including biological products for 
humans, disclose in advertisements certain information about the 
advertised product's uses and risks. For prescription drugs and 
biologics, section 502(n) of the act requires advertisements to contain 
``a true statement'' of certain information including ``information in 
brief summary relating to side effects, contraindications, and 
effectiveness'' as required by regulations issued by FDA.
    FDA's current prescription drug advertising regulations in Sec.  
202.1 (21 CFR 202.1) describe requirements for print and broadcast 
advertisements. Print advertisements must include a brief summary of 
each of the risk concepts from the product's approved package labeling 
(Sec.  202.1(e)(1)). Advertisements that are broadcast through media 
such as television, radio, or telephone communications systems must 
disclose the major side effects and contraindications of the advertised 
product in either the audio or audio and visual parts of the 
presentation (Sec.  202.1(e)(1)); this disclosure is known as the 
``major statement'' (Ref. 1).\1\
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    \1\ If a broadcast advertisement omits the major statement, or 
if the major statement minimizes the major side effects and 
contraindications associated with the use of the drug, the 
advertisement could render the drug misbranded in violation of the 
act, 21 U.S.C. 352(n) and section 201(n) of the act (21 U.S.C. 
321(n)), and FDA's implementing regulations, Sec.  202.1(e).

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[[Page 15377]]

    The current regulations further specify that an advertisement does 
not satisfy the 502(n) statutory requirement of containing a ``true 
statement'' of certain information if it: (1) Is false or misleading 
with respect to side effects, contraindications, or effectiveness; or 
(2) fails to present a fair balance between information relating to 
side effects and contraindications and information relating to 
effectiveness of the drug; or (3) fails to reveal material facts in 
light of the representations made in the advertisement or with respect 
to the consequences that may result from the use of the drug as 
recommended or suggested in the advertisement (Sec.  202.1(e)(5)). The 
regulations describe circumstances where advertisements may be false, 
lacking in fair balance, or otherwise misleading, including when an 
advertisement ``fails to present information relating to side effects 
and contraindications with a prominence and readability reasonably 
comparable with the presentation of information relating to 
effectiveness of the drug, taking into account all implementing factors 
such as typography, layout, contrast, headlines, paragraphing, white 
space, and any other techniques apt to achieve emphasis'' (Sec.  
202.1(e)(7)(viii)).
    Thus, under the current regulations the presentation of risk 
information in an advertisement for a prescription human or animal drug 
is required to be comparable in prominence and readability to the 
presentation of effectiveness information in the advertisement. If an 
advertisement presents effectiveness information in a clear and 
conspicuous manner, risk information is required to be presented in a 
comparable manner.

A. New FDAAA Requirements for DTC Radio and Television Ads

    Section 901(d)(3)(A) of FDAAA (Public Law No. 110-85) amended the 
act by adding to section 502(n) the provision that ``[i]n the case of 
an advertisement for a drug subject to section 503(b)(1) presented 
directly to consumers in television or radio format and stating the 
name of the drug and its conditions of use, the major statement 
relating to side effects and contraindications shall be presented in a 
clear, conspicuous, and neutral manner'' (emphasis added). This 
amendment augments FDA's existing authority by requiring television and 
radio advertisements for human prescription drugs to present the major 
statement (i.e., the disclosure of the major side effects and 
contraindications of the drug) in a clear, conspicuous, and neutral 
manner, regardless of the manner in which effectiveness information is 
presented in the advertisement. In this document, section 502(n) of the 
act, as amended by section 901(d)(3)(A) of FDAAA, will be referred to 
as ``section 502(n) as amended.''
    Section 901(d)(3)(B) of FDAAA states that ``[n]ot later than 30 
months after the date of the enactment of the Food and Drug 
Administration Amendments Act of 2007, the Secretary of Health and 
Human Services shall by regulation establish standards for determining 
whether a major statement relating to side effects and 
contraindications of a drug, described in section 502(n) of the Federal 
Food, Drug, and Cosmetic Act * * * is presented in the manner required 
under such section.'' As instructed by this provision of FDAAA, we are 
proposing standards for determining whether a major statement is 
presented in a ``clear, conspicuous, and neutral manner'' in DTC 
television and radio advertisements for prescription drugs intended for 
use by humans.\2\
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    \2\ Note that section 502(n) as amended applies only to 
``television or radio'' broadcast advertisements, whereas FDA's 
regulations at Sec.  202.1(e)(1) apply to advertisements broadcast 
through ``radio, television, or telephone communications systems.'' 
Consistent with section 502(n) as amended, the proposed requirements 
in this rule are limited to television and radio advertisements.
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B. Standards of Other Federal Agencies for Clear and Conspicuous

    In developing the proposed standards set forth in this rule, FDA 
has considered standards developed by other Federal agencies (including 
the Federal Trade Commission (FTC), the Department of Treasury (DOT), 
the Commodity Futures Trading Commission (CFTC), and the Securities 
Exchange Commission (SEC)) for determining whether disclosures in 
television and radio advertisements, as well as disclosures in other 
contexts, are ``clear and conspicuous.'' These standards are described 
in this document. Many of these standards are highly relevant to the 
current rulemaking in that they also aim to ensure that required 
disclosures are effectively presented so that consumers are not misled 
or deceived about the attributes of the product or service that is the 
subject of the communication. The purpose of the standards proposed 
here is similar: The effective communication of risk information in 
major statements in consumer-directed prescription drug ads so that 
consumers receive a fair and accurate impression of the drug being 
promoted.
    FTC regulates the advertising of a variety of products, including 
over-the-counter (OTC) drugs, dietary supplements, and certain medical 
devices.\3\ To prevent unfair or deceptive acts or practices, it has 
issued statements and regulations that establish standards for 
determining whether disclosures in both broadcast and print 
advertisements are clear and conspicuous. For example, in 1970, FTC 
issued an enforcement policy statement (Ref. 2) that set forth the 
following standards for determining whether an affirmative disclosure 
in a television commercial is ``clear and conspicuous'':
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    \3\ FTC has jurisdiction over OTC drug advertising under 15 
U.S.C. 52, and its authority over device advertising extends to 
devices that are not restricted devices. See section 502(q) and (r) 
of the act.
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    1. The disclosure should be presented simultaneously in both the 
audio and video portions of the television commercial (dual modality);
    2. The video portion of the disclosure must contain letters of 
sufficient size so that it can easily be seen and read on all 
television sets, regardless of picture tube size;
    3. The video portion of the disclosure should contain letters of a 
color or shade that readily contrast with the background, and the 
background should consist of only one color or shade;
    4. No other sounds, including music, should occur during the audio 
portion of the disclosure;
    5. The video portion of the disclosure should appear on the screen 
for a sufficient duration to enable it to be completely read by the 
viewer (``presentation rate''); and
    6. The audio and video portions of the disclosure should 
immediately follow the specific sales presentations to which they 
relate and should occur each time the representation is presented 
during the advertisement.
    The enforcement policy further states that ``[t]elevision 
advertisers should also consider the audience to whom the disclosure is 
directed in order to assure that persons (such as children) can 
understand the full meaning of the disclosure''.
    Similarly, in the Federal Register of May 6, 1998 (63 FR 24996 at 
25002), FTC summarized the factors it takes into account in determining 
whether audio messages, such as radio ads, are ``clear and 
conspicuous'' as follows:
    1. Volume;
    2. Cadence;
    3. Placement of a disclosure; and

[[Page 15378]]

    4. The existence of any sounds that detract from the effectiveness 
of the disclosure.
    FTC has also provided specific requirements for ``clear and 
conspicuous'' disclosures under the Telephone Disclosure and Dispute 
Resolution Act of 1992 (Public Law 102-556) (Telephone Disclosure Act). 
This legislation, in part, mandated that certain required disclosures 
appear in the advertising of pay-per-call services and directed FTC to 
prescribe regulations to govern the advertising of these services to 
avoid the abuse of consumers. In the Federal Register of August 9, 1993 
(58 FR 42364), FTC issued regulations under the Telephone Disclosure 
Act that mandate that these required disclosures in advertising of pay-
per-call services ``be made `clearly and conspicuously''' (16 CFR 
308.3(b)(2), (c)(2), (d)(2), and (f)(2)). The regulations at 16 CFR 
308.3(a) set forth the following standards for these disclosures:
    1. The disclosures shall be made in the same language as that 
principally used in the advertisement.
    2. Television video and print disclosures shall be of a color or 
shade that readily contrasts with the background of the advertisement.
    3. In print advertisements, disclosures shall be parallel with the 
base of the advertisement.
    4. Audio disclosures, whether in television or radio, shall be 
delivered in a slow and deliberate manner and in a reasonably 
understandable volume.
    5. Nothing contrary to, inconsistent with, or in mitigation of, the 
required disclosures shall be used in any advertisement in any medium; 
nor shall any audio, video, or print technique be used that is likely 
to detract significantly from the communication of the disclosures.
    6. In any program-length commercial, required disclosures shall be 
made at least three times (unless more frequent disclosure is otherwise 
required) near the beginning, middle, and end of the commercial.
    FTC has also issued guides for environmental marketing claims. 
These guides state that to be effective, the required qualifications or 
disclosures ``should be sufficiently clear, prominent and 
understandable to prevent deception. Clarity of language, relative type 
size and proximity to the claim being qualified, and an absence of 
contrary claims that could undercut effectiveness, will maximize the 
likelihood that the qualifications and disclosures are appropriately 
clear and prominent'' (16 CFR 260.6(a)). Similar standards for ``clear 
and conspicuous'' were set forth by Congress in House Report 102-839, 
which was written to accompany the House bill (H.R. 3865), the National 
Waste Reduction, Recycling, and Management Act (NWRRMA). This bill 
directed the Administrator of the Environmental Protection Agency 
(EPA), in consultation with FTC, to set, among other things, standards 
and criteria for common environmental marketing claims being used in 
advertising to inform consumers about the environmental impact or 
environmental attributes of a package or product during any part of its 
life cycle (Ref. 3). House Report 102-839 states that ``[a] disclosure 
in a broadcast commercial [for environmental marketing claims] is 
considered clear and conspicuous if, in the case of an oral broadcast, 
it is as clear and understandable in pace and volume as other 
information, and, in the case of a visual broadcast, it is presented 
against a contrasting background and is displayed for sufficient 
duration and in large enough letters to be read easily'' (emphasis 
added).
    In addition to these standards for disclosures in advertisements, a 
number of Federal regulations provide similar standards in contexts 
other than advertising for disclosures that are required to be 
presented in a ``clear and conspicuous'' manner to consumers. For 
example, in 2000 and 2001, a number of Federal agencies, including FTC, 
SEC, DOT, and CFTC, provided standards for ``clear and conspicuous'' 
disclosures in regulations that were implemented as a result of the 
privacy provisions of the Gramm-Leach-Bliley Act (Public Law 106-102) 
(GLB Act). Subtitle A of title V of the GLB Act, captioned ``Disclosure 
of Nonpublic Personal Information,'' stated, among other things, that a 
financial institution must provide its customers with ``notice'' of its 
privacy policies and practices. These notices, which can be written or 
electronic, are required by regulations issued by the above agencies to 
be ``clear and conspicuous'' such that ``[the] notice is reasonably 
understandable and designed to call attention to the nature and 
significance of the information in the notice.'' See 16 CFR 
313.3(b)(1); 12 CFR 40.3(b)(1), 216.3(b)(1), 332.3(b)(1), 573.3(b)(1); 
and 17 CFR 160.3(b)(1), 248.3(c)(1). The regulations give examples of 
when notices meet these standards. Specifically, a notice is clear or 
``reasonably understandable'' if it:
    1. Presents the information in the notice in clear, concise 
sentences, paragraphs and sections;
    2. Uses short explanatory sentences or bullet lists whenever 
possible;
    3. Uses definite, concrete, everyday words and active voice 
whenever possible;
    4. Avoids multiple negatives;
    5. Avoids legal and highly technical business terminology whenever 
possible; and
    6. Avoids explanations that are imprecise and readily subject to 
different interpretations.
    See 16 CFR 313.3(b)(2)(i); 12 CFR 40.3(b)(2)(i), 216.3(b)(2)(i), 
332.3(b)(2)(i), 573.3(b)(2)(i); and 17 CFR 160.3(b)(2)(i), 
248.3(c)(2)(i). A notice is conspicuous or ``designed to call 
attention'' if it:
    1. Uses a plain-language heading to call attention to the notice;
    2. Uses a typeface and type size that are easy to read;
    3. Provides wide margins and ample line spacing;
    4. Uses boldface or italics for key words; and
    5. Uses distinctive type size, style, and graphic devices, such as 
shading or sidebars when the notice is combined with other information.
    See 16 CFR 313.3(b)(2)(ii); 12 CFR 40.3(b)(2)(ii), 216.3(b)(2)(ii), 
332.3(b)(2)(ii), 573.3(b)(2)(ii); and 17 CFR 160.3(b)(2)(ii), 
248.3(c)(2)(ii).
    Overall, FDA believes that the standards described previously for 
``clear and conspicuous'' disclosures provide appropriate information 
for the agency to use in developing its own standards for evaluating 
major statements. Several of the policies and regulations described 
previously are similar to the ones set forth in this proposed rule in 
that they apply to consumer comprehension of disclosure information in 
television and radio advertisements. Furthermore, in issuing these 
standards, the previously mentioned agencies and Congress had goals 
similar to those of FDA in this rulemaking--ensuring that required 
information is effectively communicated to consumers so that consumers 
are not misled or deceived. For these reasons, we believe it is 
appropriate to propose standards in this rule consistent with those 
used by the previously mentioned agencies.
    We further note that common themes are seen throughout these other 
standards for ``clear and conspicuous'' disclosures. These themes 
include ease of comprehension of the language used in the disclosure; 
the formatting and location of textual information in the disclosure; 
audio considerations such as pacing, volume, and qualities of speech; 
and the presence of any distracting elements during the disclosure. We 
believe that these factors all contribute to whether the audience will 
notice, attend to, and comprehend the risk

[[Page 15379]]

information presented in the major statement in television and radio 
ads. Therefore, we believe it is appropriate to incorporate these 
themes into our standards for determining whether the major statement 
in a television or radio advertisement for a prescription drug is 
presented in a clear and conspicuous manner.

C. Standards for Neutral

    FDA is not aware of any previous standards or regulations 
concerning the definition of ``neutral manner'' in the context of 
required disclosures. FDA considers ``neutral manner'' to mean 
``unbiased manner'' and has proposed standards accordingly. (See 
section II of this document.) In addition, FDA conducted a study on the 
impact of distraction on consumer understanding of risk and benefit 
information in DTC prescription drug television broadcast 
advertisements (72 FR 47051, August 22, 2007). FDA recognizes the 
tradeoff in this study between the specificity and control of the 
research setting, and consequently the utility of the findings (and 
their generalizability) to the field as a whole. FDA also intends to 
carry out further empirical studies on how best to provide consumers 
risk and benefit information in DTC advertisements (see, for example, 
74 FR 29490, June 22, 2009). However, despite these limitations, FDA 
believes that the results of this study may provide helpful information 
for the agency to consider in determining whether a major statement is 
presented in a ``neutral'' manner. FDA is in the process of analyzing 
the results of the study and plans to place a report of the results of 
its analyses in the docket once they are complete. We will provide an 
opportunity for public comment on the results of the analyses either 
during the existing comment period or through reopening the comment 
period if necessary.

II. Proposed Amendments

    Section 502(n) as amended requires that in DTC television or radio 
advertisements for prescription drugs intended for use by humans, the 
major statement relating to the side effects and contraindications of 
an advertised prescription drug be presented in a clear, conspicuous, 
and neutral manner. FDA proposes to implement the new FDAAA 
requirements for DTC television and radio advertisements by revising 
and adding to current Sec.  202.1(e)(1) of the agency's prescription 
drug advertising regulations.

A. Major Statement in DTC Television and Radio Advertisements

    The second sentence of current Sec.  202.1(e)(1) includes specific 
requirements for advertisements broadcast through media such as radio, 
television, or telephone communications systems. The agency is 
proposing to make this current provision a separate paragraph, proposed 
Sec.  202.1(e)(1)(i), with the heading ``Broadcast advertisements.'' 
The agency is also proposing to add to the provision the term ``major 
statement'' in parentheses after the phrase ``major side effects and 
contraindications'' to reflect the terminology used in section 502(n) 
as amended.\4\
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    \4\ FDA is interpreting the term ``major statement'' in the 
statutory requirement that was added to section 502(n) of the act to 
refer to the disclosure of information relating to the ``major'' 
side effects and contraindications of the advertised drug that is 
required in broadcast advertisements under existing Sec.  
202.1(e)(1).
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B. Proposed Standards for Clear, Conspicuous, and Neutral

    FDAAA also directed FDA to establish standards for determining 
whether a major statement is presented in a ``clear, conspicuous, and 
neutral manner'' in DTC television and radio advertisements for 
prescription drugs intended for use by humans. FDA is proposing these 
standards in proposed Sec.  202.1(e)(1)(ii) with the heading ``Clear, 
conspicuous, and neutral manner.'' As presented in proposed Sec.  
202.1(e)(1)(ii), a major statement would be considered to be presented 
in this manner if:
    1. Information is presented in language that is readily 
understandable by consumers;
    2. Audio information is understandable in terms of the volume, 
articulation, and pacing used;
    3. Textual information is placed appropriately and is presented 
against a contrasting background for sufficient duration and in a size 
and style of font that allows the information to be read easily; and
    4. The advertisement does not include distracting representations 
(including statements, text, images, or sounds or any combination 
thereof) that detract from the communication of the major statement.
    These standards are consistent with the factors described and 
discussed in FDA's draft guidance for industry entitled ``Presenting 
Risk Information in Prescription Drug and Medical Device Promotion'' 
(Ref. 4).
    Standard # 1: The language used to communicate risks in the major 
statement must be comprehensible to the intended audience of the ad. 
Thus, while promotional materials directed to health care professionals 
can reasonably describe risks in medical language, promotional 
materials directed to consumers should use everyday words or terms that 
are understandable to consumers. For example, if a drug's approved 
prescribing information includes a risk of ``syncope,'' a consumer-
directed ad should mention a risk of ``fainting,'' rather than using 
the medical term ``syncope.'' The major statement should also avoid the 
use of vague terms or explanations that are readily subject to 
different interpretations. For example, if a drug's prescribing 
information indicates that more than half of patients taking the drug 
experienced a particular adverse event, the major statement should 
accurately convey the frequency of this risk (e.g., ``more than half'') 
rather than vaguely indicating that ``some patients experienced'' the 
particular adverse event.
    Standard # 2: Audio-related factors such as volume, articulation, 
and pacing can add to or detract from consumer comprehension of the 
major statement. For example, markedly reducing volume or delivering 
the major statement in an inarticulate manner hinders the audience's 
comprehension of the risks being presented. Pacing is another critical 
speech consideration. Risk information must be presented at a pace that 
allows the audience to hear and process it. If it is presented in a 
manner that is too quick for the audience to process or is otherwise 
inarticulate, it would not be considered to be clear and conspicuous.
    Standard # 3: When information from the major statement is conveyed 
in the visual as well as the audio portion of a television ad, this 
information must be placed in a manner that allows it to be easily 
read, such as parallel with the base of the ad. This information must 
also be placed such that it appears concurrently with any directly 
related audio information. There must also be sufficient contrast 
between visually-presented text and the background to highlight the 
risk information. If a television ad presents risk information in a way 
that would make it difficult to discern (e.g., using white letters on a 
light gray background or gray letters on a black background), the 
presentation would lack appropriate conspicuousness. The contrast 
between text displayed on the screen and the background color of the 
screen influences the prominence of the text once attention has been 
gained, and must be designed so that the risk information can be easily 
seen and read. Furthermore, the text must remain on

[[Page 15380]]

the screen for sufficient time to allow for consumers to identify and 
read and process the information. Font size and type style are 
additional factors that FDA will consider when evaluating whether the 
major statement is communicated in the required manner (Refs. 5 through 
10). For example, the presentation of a small visual superscript in a 
television ad is not likely to be effective in communicating 
information. Visual risk presentations must be in a type size and style 
that allows them to be easily read by viewers.
    Standard # 4: When elements of the advertisement such as images, 
text, graphics or sounds are presented in such a way as to 
significantly detract from the major statement, consumers are likely to 
be deterred from attending to and comprehending the risk information 
being presented. To achieve a ``neutral,'' unbiased presentation of the 
major statement and to avoid undercutting its effectiveness, the major 
statement must not be presented in competition with other elements if 
these elements would arrest the attention and distract consumers from 
the presentation of the risk information. Examples of these elements 
may include, but are not limited to, visuals, images, graphics or 
background music, sound effects, or other noises. This is of particular 
concern when the distracting elements convey additional benefit 
information, with the result being that risk information is not 
effectively communicated and a biased picture (i.e., one that is 
heavily weighted towards benefit information) of the product is 
conveyed by the ad.
    FDA believes that consideration of these standards will result in 
major statements in consumer ads that effectively communicate the risk 
information needed for consumers to receive a fair and accurate 
impression of the prescription drug product being promoted. FDA 
recognizes that these standards require judgment in their application. 
Therefore, the agency does not intend to prescribe a set formula for 
``clear, conspicuous, and neutral'' major statements because there is 
more than one way to achieve these standards in a television or radio 
ad. FDA intends to be flexible enough to consider the variety of 
techniques sponsors may use to appropriately convey required risk 
information in prescription drug ads. Sponsors have the flexibility to 
be creative in designing their ads as long as all of the standards 
listed here are complied with such that the major statement is 
communicated effectively to consumers and the overall message that the 
advertisement--including the major statement--conveys to consumers is 
accurate and non-misleading.
    FDA will continue to evaluate these standards to ensure that they 
result in consumer-directed ads that effectively communicate necessary 
risk information in a clear, conspicuous, and neutral way. We 
specifically request any comments on standards to establish 
``neutral.'' In addition, FDA considered adding a fifth standard that 
would require that the major statement in television advertisements be 
included in both the audio and visual parts of the presentation (see 
also section V.H of this document). This approach is similar to the FTC 
standard, which states that for disclosures in a television 
advertisement to be clear and conspicuous, they should be presented 
simultaneously in both the audio and video (Ref. 2). We believe 
presenting the major statement in both the audio and visual portions of 
television ads could enhance the clarity, conspicuousness, and 
neutrality of this information. While this proposed rule does not 
contain such a standard, we are soliciting public comment on whether 
the final rule should contain a standard requiring that major 
statements in television ads be presented in both the audio and visual 
parts of the ad.

C. Minor Changes

    We are also proposing minor changes to update Sec.  202.1(e)(1) and 
make the regulation clearer. We are proposing to add punctuation, 
including setting off with commas the phrase ``unless adequate 
provision is made for dissemination of the approved or permitted 
package labeling in connection with the broadcast presentation,'' and 
to replace the word ``shall'' with the word ``must'' in the two places 
it is found in Sec.  202.1(e)(1).

D. Proposed Effective Date

    In accordance with FDAAA, the requirement that the major statement 
in DTC television and radio advertisements be presented in a clear, 
conspicuous and neutral manner has been in effect since March 25, 2008. 
FDA proposes that the standards in any final rule that may issue based 
on this proposal become effective 90 days after its publication in the 
Federal Register. Any DTC television or radio ad for a prescription 
drug intended for use by humans that airs on or after the effective 
date will be required to comply with the standards. FDA seeks public 
comment on its proposed 90 day effective date for any final rule that 
may issue based on this proposed rule.

III. Legal Authority

    This rule, if finalized, would amend Sec.  202.1 in a manner 
consistent with the agency's current understanding and application of 
this provision. FDA was directed by FDAAA to establish standards for 
determining whether the major statement in television and radio 
advertisements for prescription drugs intended for use by humans is 
presented in a clear, conspicuous, and neutral manner. Furthermore, FDA 
has the authority to take the actions proposed in this rule under 
various statutory provisions. These provisions include sections 201, 
301, 502, 505, 512, and 701 of the act (21 U.S.C. 321, 331, 352, 355, 
360b, and 371).

IV. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). OMB has determined that 
this proposed rule is a significant regulatory action.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because small entities rarely engage in television 
or radio advertising of prescription drugs and the proposed changes 
would impose little additional cost per advertisement, the agency 
proposes to certify that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local,

[[Page 15381]]

and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $133 
million, using the most current (2008) Implicit Price Deflator for the 
Gross Domestic Product. FDA does not expect this proposed rule to 
result in any 1-year expenditure that would meet or exceed this amount.
    Under section 901(d)(3)(A) of FDAAA, Congress has mandated that the 
major statement in prescription drug television and radio 
advertisements be presented in a ``clear, conspicuous and neutral 
manner.'' Section 901(d)(3)(B) of FDAAA mandates that FDA issue 
regulations that establish standards for determining whether a major 
statement is presented in such a manner. In accord with this 
legislation, the proposed rule would implement provisions of FDAAA by 
requiring that the major statement be presented in a clear, 
conspicuous, and neutral manner; and by presenting standards for 
determining whether such major statements are presented in a clear, 
conspicuous, and neutral manner.

A. Scale of Advertisements

    Industry expenditures on DTC advertisements of prescription drugs 
have increased dramatically since 1997. Prior to 1997, the majority of 
DTC promotion occurred in print; companies were unclear at that time 
about how they could comply with the requirements applicable to 
broadcast media (in particular, the requirement in Sec.  202.1(e)(1) 
that advertisers make ``adequate provision'' for dissemination of the 
product's package labeling). In 1997, FDA issued a draft guidance 
describing an approach for fulfilling the requirement for adequate 
provision in connection with broadcast advertising for prescription 
products (Ref. 1). Following the issuance of the draft guidance, 
companies expanded their consumer-directed promotional efforts to 
include broadcast advertisements. Advertising expenditures increased as 
companies began to use the costlier medium of broadcast to promote 
their products to consumers. From a reported total expenditure of less 
than $1 billion in 1997 (Ref. 11), industry spending on DTC 
advertisements for prescription drugs peaked at $4.9 billion in 2007, 
before declining to $4.4 billion in 2008 (Ref. 12). This amount far 
exceeded the $387 million spent on professional journal advertising, 
but was somewhat less than the $6.5 billion spent on detailing efforts 
by industry sales representatives in that year (Ref. 12), and only a 
fraction of the $14.1 billion retail value of free samples distributed 
in 2008 (Ref. 13). In contrast, the total value of U.S. prescription 
drug sales reached almost $300 billion in 2008 (Ref. 14).
    In 2008, FDA's Center for Drug Evaluation and Research (CDER) 
reviewed 271 DTC television advertisements and 94 radio advertisements 
for products under their jurisdiction. The television ads were 
submitted by 41 companies and the radio ads were submitted by 20 
companies. The Center for Biologics Evaluation and Research (CBER) 
reviewed 10 DTC television ads from 2 companies and 5 radio ads from 3 
companies. Overall, 48 different companies submitted advertisements to 
1 or more centers in 2008.

B. Need for Regulation

    Section 502(n) as amended requires that the major statement be 
presented in a clear, conspicuous, and neutral manner, but the statute 
and our current regulations do not describe standards for what FDA 
would consider clear, conspicuous, and neutral. This proposed rule is 
needed to implement this statutory requirement.
    Further, in discussing the need for Federal regulatory action, OMB 
has advised Government agencies that ``[w]hen it is time-consuming or 
costly for consumers to evaluate complex information about products or 
services (e.g., medical therapies), they may expect government to 
ensure that minimum quality standards are met'' (Ref. 15). OMB 
continues, however, that ``the mere possibility of poor information 
processing is not enough to justify regulation. If you think there is a 
problem of information processing that needs to be addressed, it should 
be carefully documented.'' Therefore, the following discussion: (1) 
Addresses the percentage of recent television and radio advertisements 
that do not include clear, conspicuous, and neutral presentations of 
risk information, (2) describes the effects of unclear presentations on 
consumer understanding of product risks, and (3) explores the health 
consequences that may result from these misunderstandings.

C. Baseline Practice

    To develop a baseline estimate of the percentage of major 
statements that were not presented in a clear, conspicuous, and neutral 
manner, FDA's Division of Drug Marketing, Advertising, and 
Communications (DDMAC) in CDER examined a randomly selected sample of 
35 television and radio drug advertisements disseminated in 2008. As 
shown in table 1 of this document, this survey found that approximately 
one-third of the reviewed advertisements could be judged in violation 
of a clear, conspicuous, and neutral standard. Such results clearly 
suggest that current regulatory and statutory requirements have not 
adequately prevented the broadcast of a significant number of 
potentially misleading or deceptive discussions of product risk.

  Table 1.--DDMAC's Review of Radio and Television Advertisements from
                                  2008
------------------------------------------------------------------------
                             Radio ads    Television ads      Overall
         Outcome               (n=5)           (n=30)         (n=35)
------------------------------------------------------------------------
Violates existing fair                 2               7               9
 balance regulations and
 violates clear,
 conspicuous, and
 neutral (CCN) statute
------------------------------------------------------------------------
Violates only existing                 1               1               2
 fair balance
 regulations
------------------------------------------------------------------------
Does not violate                       0               3               3
 existing fair balance
 regulations but
 violates CCN statute
------------------------------------------------------------------------
Does not violate                       2              19              21
 existing fair balance
 regulations and does
 not violate CCN statute
------------------------------------------------------------------------
Does not violate CCN             3 (60%)        20 (67%)        23 (66%)
 statute
------------------------------------------------------------------------
Violates CCN statute             2 (40%)        10 (33%)        12 (34%)
------------------------------------------------------------------------


[[Page 15382]]

    We understand, however, that this survey may not be indicative of 
present and future television and radio promotions. First, television 
advertisements have a relatively short life and typically run for about 
3 months to a year (Ref. 16). The affected firms will have had several 
years since the 2007 enactment of FDAAA to refine later broadcast 
advertisements. Moreover, the Pharmaceutical Research and Manufacturers 
of America's (PhRMA's) publication of voluntary guidelines regarding 
DTC advertisements was revised in December 2008, to (among other 
things) specify that risks and safety information in DTC advertising 
should be presented in a ``clear, conspicuous and neutral manner, and 
without distraction from the content'' (Ref. 17). This guideline may 
influence industry performance and thereby decrease the number of 
television and radio advertisements that fail to present risk 
information in a clear, conspicuous, and neutral manner. Therefore, we 
expect that industry compliance would improve significantly over the 
sample in table 1 of this document by the time a final rule takes 
effect. Those DTC television and radio advertisements that do not 
comply with the new standards at the time a final rule takes effect 
would, however, need to be revised or removed. To refine this baseline 
for analysis, FDA seeks public comment and industry data on pertinent 
trends in pharmaceutical television and radio promotions.

D. Effects on Consumer Understanding

    The preceding discussion demonstrates that a significant number of 
recent broadcast advertisements have failed to present a clear, 
conspicuous, and neutral discussion of prescription drug risks. These 
omissions may be at least partially responsible for a lack of consumer 
comprehension of product hazards. When risk messages are presented in a 
vague or difficult to understand manner, they are easily misinterpreted 
and consumers are more likely to be misled. For example, 60 percent of 
the responding physicians in one large survey believed that DTC 
advertisements for prescription drugs provided patients with little or 
no understanding about the risks and negative effects of the products 
(Ref. 18). Over 65 percent of these physicians observed that DTC 
advertisements may lead patients to confuse the relative risks and 
benefits of advertised drugs. The proposed rule would help address this 
lack of understanding by providing standards for the major statement in 
television or radio advertisements for prescription drugs.

E. Health Consequences

    To the extent that risk information in current DTC advertisements 
is not presented in a clear, conspicuous, and neutral manner, this 
proposed rule could potentially have a positive effect on health 
outcomes through better communication of the risk information in 
prescription drug television and radio advertisements. The magnitude of 
these potential health benefits would vary with the influence of these 
promotions on consumer health decisions.
    The growing body of research on the influence of DTC advertisements 
on public health has generated mixed results. The agency contracted 
with Eastern Research Group (ERG) in 2008 to review and summarize the 
relevant peer-reviewed literature on DTC advertising published between 
2004 and 2008 (Ref. 19). This review was an extension of work already 
published by FDA in 2004 summarizing its survey research results on the 
public health impacts of DTC advertising (Ref 18). Highlights of some 
of the research findings in the ERG report are described as follows. 
See the ERG report for a comprehensive discussion of the literature 
covered by the review.
    The purpose of DTC prescription drug advertising is to increase the 
demand for the advertised prescription drugs, and researchers have 
generally found that to have happened. In addition, some research has 
shown that DTC advertising for a particular drug increased the demand 
for the entire therapeutic class. Other effects include increased rates 
of drug therapy compliance, although the size of this effect may be 
small. DTC advertising has also been shown to produce indirect, or 
spillover, effects on consumer behavior, such as increasing the number 
of physician visits that detect treatable disease (Ref. 20).
    On the other hand, positive outcomes are less probable when drug 
promotions are biased and provide an incomplete or confusing account of 
the drug's likely effects. Some analysts find that DTC ads cause 
physicians to waste valuable time responding to patient requests (Ref. 
21) and can encourage an increased and sometimes inappropriate demand 
for the advertised products (Ref. 21 and 22).
    This proposed rule could potentially improve the communication of 
risk information, thereby resulting in the audience receiving a more 
accurate net impression of the product's benefits and risks. We cannot 
quantify the magnitude of the health impact resulting from a potential 
improvement in risk communication because of the absence of studies 
that analytically assess the full range of advantages and disadvantages 
of DTC advertising for prescription drugs. One survey of the 
literature, for example, explains that ``no studies have examined the 
impact of direct to consumer advertising on either health outcomes or 
examined the costs and health and social consequences of DTCA [DTC 
advertising]'' (Ref. 23). Likewise, FDA has identified no authoritative 
research on the overall health consequences of DTC advertising. Without 
a measure of the overall impact of DTC ads, we cannot reasonably 
develop a quantifiable estimate of the incremental consequences of 
requiring more understandable risk discussions in DTC advertising. 
Nevertheless, it is plausible that providing standards for presenting 
risk information in DTC drug advertisements in a clear, conspicuous, 
and neutral manner could generate positive health benefits.

F. Costs of Compliance

    FDA regulations currently require that broadcast advertisements 
present information relating to the major side effects and 
contraindications of the product, and the 2007 FDAAA requires that such 
information be presented in a clear, conspicuous, and neutral manner. 
The proposed regulation would provide standards for what would be 
considered clear, conspicuous, and neutral to further consumer 
comprehension. Once the rule is in effect, manufacturers would have to 
take these standards into account when developing advertising materials 
for television or radio.
    This proposed rule would lead to the one-time cost to advertisers 
of setting up new guidelines or standard operating procedures for 
meeting the clear, conspicuous, and neutral criteria. FDA estimates 
that from one-third (17) to all of approximately 50 firms who submitted 
advertisements would bear these one-time costs. We tentatively estimate 
that these revisions would require 10 to 20 hours of upper management 
time at $134 per hour, 40 to 80 hours of marketing management time at a 
cost of $88 per hour, and 80 to 120 hours of technical writing time at 
a cost of $42 per hour.\5\ The cost per revision would range from 
$8,220 to $14,760. We estimate the total one-time costs of the 
revisions to range from $140,000 (17 x $8,220) to $740,000 (50 x 
$14,760). FDA requests comments on

[[Page 15383]]

this estimated range of costs and its components.
---------------------------------------------------------------------------

    \5\ Bureau of Labor Statistics, ``Occupational Employment 
Statistics: May 2008 National Industry-Specific Occupational 
Employment and Wage Estimates, NAISC 325400--Pharmaceutical and 
Medical Manufacturing,'' Wages were increased by 40 percent to 
include fringe benefits. Downloaded January 2009. http://www.bls.gov/oes/2008/may/naics4_325400.htm
---------------------------------------------------------------------------

    FDA assumes that this proposed rule will not increase the length of 
broadcast time for radio and television ads. The requirement to present 
risk information in a clear, conspicuous, and neutral manner is already 
in effect in accordance with section 502(n) as amended. The proposed 
standards for determining clear, conspicuous, and neutral will provide 
guidance that should reduce regulatory uncertainty in developing major 
statements. Advertising agencies take great pains to create promotional 
programs that portray product attributes in the most favorable way. For 
the most part, advertising messages are crafted to be as persuasive as 
possible, while complying with applicable regulatory restrictions. In 
the design stage, ad developers consider and evaluate a variety of 
facts, features, layouts, and formats before making a final decision. 
The proposed rule would not require ads to be more intricate or 
exhaustive; on the contrary, the standards would encourage ads that are 
simpler and less dramatically charged. Thus, although the standards for 
clear, conspicuous, and neutral might constrain some design choices, 
the creation of compliant broadcasts would not require the use of a 
greater quantity of productive resources.
    For the most part, key advertising agencies would be aware of the 
pertinent rules and would tailor their compositions accordingly. While 
in the short term, some additional draft submissions might occur as 
industry became familiar with the new standards, this incremental 
effort would be minimal. Indeed, because the requirement to present 
risk information in a clear, conspicuous, and neutral manner is already 
in effect in accordance with section 502(n) as amended, the issuance of 
defined standards should reduce regulatory uncertainty, which in turn 
could reduce regulatory costs.
    To account for any additional burdens associated with third party 
disclosure attributable to section 901(d)(3)(A) and (d)(3)(B) of FDAAA, 
the agency estimates an additional 5 hours per television or radio 
advertisement would be required for about 420 ads per year, or a total 
burden of 2,100 hours per year (see table 2 of this document). The 
total cost for this burden is $184,800 per year assuming a wage rate of 
$88 per hour. Although most of this cost is associated with section 
901(d)(3)(A) of FDAAA, a small fraction of this cost would be 
attributed to this proposed rule (section 901(d)(3)(B) of FDAAA).
    Because the time period between issuance of any final rule based on 
this proposed rule and effective date of the final rule should be 
longer than the life cycle of most DTC television and radio 
advertisements, future advertisements should cost about the same to 
produce once the firm's guidelines (standard operating procedures) for 
clear, conspicuous, and neutral risk statements are incorporated. If 
the time period is not sufficient to encompass the life cycle of an 
advertisement, the likely response would be for the firm to revise the 
advertisement. Industry sources indicate that these revisions would on 
average cost $100,000 to $150,000 per television advertisement and 
$10,000 to $20,000 per radio advertisement. The agency seeks comments 
on this assessment of costs of compliance.
    In summary, the incremental costs of compliance with this proposed 
rule include the following:
     a one-time cost to establish new guidelines or standard 
operating procedures of from $140,000 to $740,000;
     annual costs amounting to a small fraction of the total 
third party disclosure burden of $184,800; and
     a one-time cost of from $100,000 to $150,000 per 
television advertisement and from $10,000 to $20,000 per radio 
advertisement to revise any advertisement with a life cycle extending 
beyond the compliance date of the final rule.

G. Distributional Effects

    It is also possible that some individual firms would lose market 
share if forced to make their risk information more understandable. 
Should the provision of more understandable risk information lead to 
reduced demand for particular products, the proposed rule could lead to 
lost revenue and reduced producer surplus for individual firms. The 
reduced demand for particular products, however, may lead to increased 
demand for substitute products. Losses for firms whose products 
experience reduced demand could be offset by gains accruing to firms 
whose products experience increased demand. The effect of such changes 
in demand could be a net benefit to society, depending on the magnitude 
of any positive health outcomes associated with changes in the 
consumption of prescription drugs, if any. To the extent that some lost 
revenues are not transferred to substitute drug products, these losses 
would not be offset.

H. Alternatives Considered

    As directed by FDAAA, the agency is proposing standards for 
determining whether the major statement in television and radio 
prescription drug advertisements is presented in a clear, conspicuous, 
and neutral manner. FDA considered the following alternatives to this 
proposed rule.
    We considered, as an alternative, relying on guidance rather than 
regulation for providing the standards for determining clear, 
conspicuous, and neutral. See, for example, FDA's draft guidance for 
industry entitled ``Presenting Risk Information in Prescription Drug 
and Medical Device Promotion'' (Ref. 4). Guidance documents, however, 
are not legally enforceable. Even if most firms would comply 
voluntarily, FDA needs to ensure that standards would be implemented 
for all important risk messages in prescription drug television and 
radio ads. In addition, because section 901(d)(3)(B) of FDAAA requires 
that FDA establish standards by regulation, this alternative would not 
conform to the statute.
    We also considered requiring specific standards for how audio and 
visual disclosures should be formatted in advertisements, such as 
specific font sizes, contrast colors, placement of textual information, 
and language. We concluded, however, that this level of detail was 
unnecessary because there is more than one way to present risk 
information in a clear, conspicuous, and neutral manner.
    We also considered requiring that the major statement in television 
advertisements be included in both the audio and visual parts of the 
presentation. This approach is similar to the FTC standard, which 
states that for disclosures in a television advertisement to be clear 
and conspicuous, they should be presented simultaneously in both the 
audio and video (Ref. 2). Research has shown that presenting the same 
information in both the audio portion and as visual superimposed text 
increases the comprehension of that information compared with 
information presented in only one of those modes. This has been called 
dual-mode processing and has been shown in multiple studies on 
advertising to improve recall of the communicated information over and 
above that seen in audio mode alone (Refs. 24 and 25). In addition to 
these specific studies on the use of superimposed text in ads, the 
literature suggests that a dual mode presentation of information 
results in greater recall and comprehension of information in a

[[Page 15384]]

wide variety of situations (Refs. 26 through 30). The theories to 
support this finding stem from theories of basic memory processing 
(Ref. 31). To learn and use knowledge, information first must be 
encoded in memory by being attended to or noticed, then stored in 
memory, and then retrieved from memory. When people attend to 
information in two modes (visual and audio), they may form two separate 
codes for that same information, resulting in greater elaboration of, 
or thinking about, the information than they might have with only one 
code (Ref. 32). It is also possible that presenting the information in 
two modes reduces possible interference from other messages that might 
be present on the screen at the time of the ad. Thus, presenting the 
major statement in both the audio and visual portions of television ads 
could enhance the clarity, conspicuousness, and neutrality of this 
information. FDA is specifically requesting comments on this 
alternative.
    To estimate the costs of this alternative, we assume that none of 
the affected firms would be compliant. Therefore, based on 2008 
submissions, approximately 50 firms would incur one-time costs to 
modify their standard operating procedures. We calculated the range of 
one-time costs for the proposed rule as $140,000 to $740,000. Because 
all 50 firms would bear these costs, the one-time costs for this 
alternative would be in the upper end of the range, from $410,000 to 
$740,000.
    In addition, existing television ads, or television ads in the 
final stages of production, may need to be modified to include 
superimposed text and other adjustments. The agency estimates that 
modifications of existing advertisements to comply with this 
alternative may cost approximately $100,000 to $150,000 per television 
advertisement. We cannot predict the number, if any, of existing 
advertisements that would be revised. If all of the 281 television ads 
from 2008 required these changes, however, the additional one-time 
costs would be $28.1 to $42.2 million. The agency requests detailed 
data on these cost estimates.

I. Small Business Impact

    FDA finds that the proposed regulation would not have a significant 
impact on a substantial number of small entities. The Small Business 
Administration (SBA) defines as small any pharmaceutical preparations 
manufacturing entity (NAICS 325412) with fewer than 750 employees and 
any biologics product manufacturing entity (NAICS 325414) with fewer 
than 500 employees. Among the 48 companies submitting television or 
radio advertisements to FDA in 2008, only about 5 would meet the SBA 
definition of small entity. Thus, we estimate that only a few of the 
manufacturers affected by the proposed rule would be a small business. 
We estimate the one-time cost to revise procedures for meeting the 
clear, conspicuous, and neutral criteria would range from $8,228 to 
$14,760 per firm. Because the time period between issuance of any final 
rule based on this proposed rule and the effective date of the final 
rule should be longer than the life cycle of most DTC television and 
radio advertisements, future advertisements should cost about the same 
to produce once the guidelines for clear, conspicuous, and neutral risk 
statements are incorporated. If the time period is not sufficient to 
encompass the life cycle of an advertisement, the likely response would 
be for the firm to revise the advertisement. Using the cost of revising 
television advertisements as an upper bound, industry sources indicate 
that these revisions would on average cost $100,000 to $150,000 per 
advertisement.
    Because there is wide variation in the revenues of small firms, the 
agency cannot assess the impact of the one-time compliance costs as a 
percent of average firm revenues for those small businesses that 
produce television ads. However, firms spend on average about $1 
million to produce a single television ad. The one-time compliance 
costs for adjusting procedures represents about 1 percent of the cost 
of a single ad. If a company needed to revise its existing advertising, 
the upper bound of compliance costs would range from 11 percent to 16 
percent of the production cost of a single advertisement, which would 
be a small fraction of the firm's revenues.
    Advertising agencies would not experience significant adverse 
economic impacts because the cost of producing compliant work products 
should be no greater than the cost of producing less informative 
advertisements. The agency seeks comments on this assessment.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains collections of information that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 3520) (the PRA). ``Collection of information'' includes any 
request or requirement that persons obtain, maintain, retain, or report 
information to the agency, or disclose information to a third party or 
to the public (44 U.S.C. 3502(3) and 5 CFR 1320.3(c)). The title, 
description, and respondent description of the information collection 
are shown under this section with an estimate of the annual reporting 
burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    We invite comments on these topics: (1) Whether the collection of 
information is necessary for proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Direct-to-Consumer Prescription Drug Advertisements; 
Presentation of the Major Statement in Television and Radio 
Advertisements in a Clear, Conspicuous, and Neutral Manner
    Description: Under Sec.  202.1, FDA establishes requirements for 
advertisements for human and animal prescription drug products and 
biological products. The regulations apply to advertisements published 
in journals, magazines, other periodicals, and newspapers, and 
advertisements broadcast through media such as radio, television, and 
telephone communication systems. Under Sec.  202.1(e)(1), FDA's 
regulations describe when a true statement of information in brief 
summary relating to side effects, contraindications, and effectiveness 
is required. In this proposed rule, the agency is proposing to amend 
these regulations. Specifically, under proposed Sec.  202.1(e)(1)(ii), 
FDA would implement section 502(n) as amended, which requires that the 
major statement in a DTC television or radio advertisement for a 
prescription drug intended for human use be presented in a clear, 
conspicuous, and neutral manner. The rule also includes proposed 
standards for determining whether the major statement is presented in a 
clear, conspicuous, and neutral manner. Television and radio 
advertisements subject to the requirements at proposed Sec.  
202.1(e)(1)(ii) are subject to the PRA because these advertisements 
disclose information to the public.
    According to FDA data, CDER estimates that approximately 300 
television advertisements for prescription drugs would be prepared

[[Page 15385]]

by approximately 30 companies under proposed Sec.  202.1(e)(1)(ii) 
annually and CBER estimates that approximately 15 of these 
advertisements would be prepared by approximately 5 companies annually. 
FDA anticipates that this estimate will moderately increase in the near 
future. The estimated total number of television advertisements under 
proposed Sec.  202.1(e)(1)(ii) would be 315. Based on its experience 
reviewing television advertisements, FDA estimates that approximately 5 
hours on average would be needed per advertisement to comply with the 
proposed requirement that the major statement in DTC television 
advertisements be presented in a clear, conspicuous, and neutral manner 
(proposed Sec.  202.1(e)(1)(ii)).
    Further, according to FDA data, CDER estimates that approximately 
100 radio advertisements for prescription drugs would be prepared by 
approximately 20 companies under proposed Sec.  202.1(e)(1)(ii) 
annually and CBER estimates that approximately 5 of these 
advertisements would be prepared by approximately 3 companies annually. 
FDA anticipates that this estimate will moderately increase in the near 
future. The estimated total number of radio advertisements under 
proposed Sec.  202.1(e)(1)(ii) would be 105. Based on its experience 
reviewing radio advertisements, FDA estimates that approximately 5 
hours on average would be needed per advertisement to comply with the 
proposed requirement that the major statement in DTC radio 
advertisements be presented in a clear, conspicuous, and neutral manner 
(proposed Sec.  202.1(e)(1)(ii)).
    FDA estimates the burden of this collection of information as 
follows:

                           Table 2.--Estimated Annual Third Party Disclosure Burden\1\
----------------------------------------------------------------------------------------------------------------
   21 CFR         Type of          No. of       Annual Frequency   Total Annual      Hours per
   Section       Submission      Respondents     per Disclosure     Disclosures    Disclosure\3\    Total Hours
----------------------------------------------------------------------------------------------------------------
202.1(e)(1)(  Television                   35                  9             315               5           1,575
 ii)2          Advertisements
             ---------------------------------------------------------------------------------------------------
              Radio                        23                  5             105               5             525
               Advertisements
----------------------------------------------------------------------------------------------------------------
Total         ...............              58                 14             420               5           2,100
----------------------------------------------------------------------------------------------------------------
\1\ FDA assumes that this proposed rule will not increase the length of broadcast time for radio and television
  ads.
\2\ In accordance with section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)), and 5 CFR 1320.12(b), FDA has
  published in the Federal Register a 60-day notice soliciting public comment on the collections of information
  that result from current Sec.   202.1, including the estimated burden of current requirements for third party
  disclosures in television and radio advertisements. See 75 FR 12756, March 17, 2010.
\3\ The estimated hours represent the burden of complying with sections 901(d)(3)(A) and (d)(3)(B) of FDAAA as
  implemented by this proposed rule.

    We specifically request comment on the burden hour estimates 
described previously in this document and in table 2 of this document.

Costs

    In addition to the burden hours in table 2 of this document, FDA 
estimates the following costs associated with the information 
collection. Although the proposed rule neither requires nor recommends 
the creation of guidelines or standard operating procedures for meeting 
the clear, conspicuous, and neutral requirement, if implemented, it may 
lead some companies to incur a one-time cost for revising guidelines or 
standard operating procedures for ensuring compliance with the 
underlying requirement (see also section V.F of this document). We 
estimate that from 17 to 50 companies would bear these one-time costs, 
and that these revisions would require 10 to 20 hours of upper 
management time at $134 per hour, 40 to 80 hours of marketing 
management time at a cost of $88 per hour, and 80 to 120 hours of 
technical writing time at a cost of $42 per hour. The cost per revision 
would range from $8,220 to $14,760. We estimate the total one-time 
costs of the revisions to range from $140,000 (17 x $8,220) to $740,000 
(50 x $14,760).
    Finally, although future advertisements should cost about the same 
to produce once the companies' guidelines (standard operating 
procedures) for clear, conspicuous, and neutral risk statements are 
adopted, if the time period is not sufficient to encompass the life 
cycle of an advertisement, the likely response would be for the company 
to revise the advertisement. Based on industry sources, we estimate 
that these revisions would on average cost $100,000 to $150,000 per 
television advertisement and $10,000 to $20,000 per radio advertisement 
(see also section V.F of this document).
    Description of Respondents: Manufacturers, packers, and 
distributors, and applicants with approved new drug applications 
(NDAs), abbreviated new drug applications (ANDAs), and biologics 
licensing applications (BLAs) and those that market prescription drugs 
for human use without an approved application.
    The information collection provisions of this proposed rule have 
been submitted to OMB for review. Interested persons are requested to 
fax comments regarding information collection by (see DATES section of 
this document), to the Office of Information and Regulatory Affairs, 
OMB. To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should reference the title of this rule and include the FDA 
docket number found in brackets in the heading of this document.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
the agency has concluded that the proposed rule does not contain 
policies that have federalism implications as defined in the Executive 
order and, consequently, a federalism summary impact statement is not 
required.

VIII. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that

[[Page 15386]]

individuals may submit one paper copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
    1. FDA guidance for industry, ``Consumer-Directed Broadcast 
Advertisements,'' available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070065.pdf.
    2. CCH Trade Regulation Reporter, Paragraph 7569.09 ``Clear and 
Conspicuous Disclosure,'' October 21, 1970.
    3. H. Rept. No. 102-839, August 11, 1992.
    4. FDA draft guidance for industry, ``Presenting Risk 
Information in Prescription Drug and Medical Device Promotion,'' 
available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf (May 
2009).
    5. Adams, A.S. and J. Edworthy, ``Quantifying and Predicting the 
Effects of Basic Text Display Variables on the Perceived Urgency of 
Warning Labels: Tradeoffs Involving Font Size, Border Weight, and 
Colour,'' Ergonomics, 38:2221-2237, 1995.
    6. Arditi, A. and J. Cho, ``Serifs and Font Legibility,'' Vision 
Research, 45:2926-2933, 2005.
    7. Baker, S., ``Provision of Effective Information,'' British 
Dental Journal, 201:100, 2006.
    8. Sheedy, J.E., M.V. Subbaram, A.B. Zimmerman, et al., ``Text 
Legibility and the Letter Superiority Effect,'' Human Factors, 
47:797-815, 2005.
    9. Tantillo, J., J. Di Lorenzo-Aiss, and R.E. Mathisen, 
``Quantifying Perceived Differences in Type Styles: An Exploratory 
Study,'' Psychology and Marketing, 12:447-457, 1995.
    10. Wogalter, M.S. and W.J. Vigilante, ``Effects of Label Format 
on Knowledge Acquisition and Perceived Readability By Younger and 
Older Adults,'' Ergonomics, 46:327-344, 2003.
    11. Winstein, K.J. and S. Vranica, ``Drug Firms' Spending on 
Consumer Ads Fell 8% in '08, a Rare Marketing Pullback,'' Wall 
Street Journal, April 16, 2009.
    12. IMS Health, Total U.S. Promotional Spend By Type, 2008, 
available at http://www.imshealth.com/deployedfiles/imshealth/Global/Content/StaticFile/Top_Line_Data/U.S._Promo_Spend_Data_2008.pdf, downloaded September 2009.
    13. IMS Health, Integrated Promotional Services\TM\, Year 2008, 
Data Extracted on September 2009.
    14. IMS Health, ``IMS Health Reports U.S. Prescription Sales 
Grew 1.3 Percent in 2008 to $291 Billion,'' (www.imshealth.com, News 
Releases, March 19, 2009).
    15. Office of Management and Budget, Circular A-4, September 17, 
2003.
    16. General Accounting Office, ``Prescription Drugs: FDA 
Oversight of Direct-to-Consumer Advertising Has Limitations,'' GAO-
03-177, p. 23, October 2002.
    17. PhRMA, ``PhRMA Guiding Principles; Direct to Consumer 
Advertisements About Prescription Medicines,'' revised December 
2008.
    18. Aikin, K., J. Swasy, and A. Braman, ``Patient and Physician 
Attitudes and Behaviors Associated With DTC Promotion of 
Prescription Drugs--Summary of FDA Survey Research Results, Final 
Report,'' November 19, 2004.
    19. Eastern Research Group, Inc., ``Scientific Literature on 
Direct-to-Consumer Advertising of Prescription Pharmaceuticals, 
2004-2008: Literature Review,'' January 2009.
    20. Weissman, J.S., D. Blumenthal, A.J. Silk, et al., 
``Consumers' Reports on the Health Effects of Direct-to-Consumer 
Drug Advertising,'' Health Affairs, W3-82-W3-95, posted February 26, 
2003, http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w3.82v1.
    21. Murray, E., B. Lo, L. Pollack, et al., ``Direct-to-Consumer 
Advertising: Physicians' Views of Its Effects on Quality of Care and 
the Doctor-Patient Relationship,'' Journal of the American Board of 
Family Practice, 16(6):513-524, 2003.
    22. Mintzes, B., M. Barer, R.L. Kravitz, et al., ``Influence of 
Direct to Consumer Pharmaceutical Advertising and Patients' Requests 
on Prescribing Decisions: Two Site Cross Sectional Survey,'' British 
Medical Journal, 324:278-279, 2002.
    23. Gilbody, S., P. Wilson, and I. Watt, ``Benefits and Harms of 
Direct to Consumer Advertising: A Systematic Review,'' Quality and 
Safety in Health Care, 14:246-250, 2005.
    24. Morris, L.A., M.B. Mazis, and D. Brinberg, ``Risk 
Disclosures in Televised Prescription Drug Advertising to 
Consumers,'' Journal of Public Policy & Marketing, 8:64-80, 1989.
    25. Murray, N.M., L.A. Manrai, and A.K. Manrai, ``How Super Are 
Video Supers? A Test of Communication Efficacy,'' Journal of Public 
Policy & Marketing, 17(1):24-34, 1998.
    26. Brewer, N., S. Harvey, and C. Semmler, ``Improving 
Comprehension of Jury Instructions With Audio-Visual Presentation,'' 
Applied Cognitive Psychology, 18(6):765-776, 2004.
    27. Chung, K.K.H., ``What Effect Do Mixed Sensory Mode 
Instructional Formats Have on Both Novice and Experienced Learners 
of Chinese Characters?'' Learning and Instruction, 18(1):96-108, 
2008.
    28. Frick, R.W., ``Using Both an Auditory and a Visual Short-
Term Store to Increase Digit Span,'' Memory & Cognition, 12:507-514, 
1984.
    29. Lang, A., ``Defining Audio/Video Redundancy From a Limited-
Capacity Information Processing Perspective,'' Communication 
Research, 22(1):86-115, 1995.
    30. Walma van der Molen, J.H., and M.E. Klijn, ``Recall of 
Television Versus Print News: Retesting the Semantic Overlap 
Hypothesis,'' Journal of Broadcasting & Electronic Media, 48(1):89-
107, 2004.
    31. Galotti, K.M., Cognitive Psychology: In and Out of the 
Laboratory (3rd Ed)., pp. 129-207, Belmont, CA: Wadsworth/Thomson 
Learning, 2004.
    32. Paivio, A., ``The Empirical Case for Dual Coding,'' In 
Yuille, J. (Ed.), Imagery, Memory, and Cognition: Essays in Honor of 
Allan Paivio, pp. 307-332, Hillside, NJ: Lawrence Erlbaum 
Associates, 1983.

List of Subjects in 21 CFR Part 202

    Advertising, Prescription drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 202 be amended as follows:

PART 202--PRESCRIPTION DRUG ADVERTISING

    1. The authority citation for 21 CFR part 202 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 352, 355, 360b, 371.
    2. Section 202.1 is amended by revising paragraph (e)(1) to read as 
follows:


Sec.  202.1   Prescription-drug advertisements.

* * * * *
    (e) True statement of information in brief summary relating to side 
effects, contraindications, and effectiveness:
    (1) When required. All advertisements for any prescription drug 
(``prescription drug'' as used in this section means drugs defined in 
section 503(b)(1) of the act and Sec.  201.105, applicable to drugs for 
use by man and veterinary drugs, respectively), except advertisements 
described in paragraph (e)(2) of this section, must present a true 
statement of information in brief summary relating to side effects, 
contraindications (when used in this section ``side effects, 
contraindications'' include side effects, warnings, precautions, and 
contraindications and include any such information under such headings 
as cautions, special considerations, important notes, etc.), and 
effectiveness.
    (i) Broadcast advertisements. Advertisements broadcast through 
media such as radio, television, or telephone communications systems 
must include information relating to the major side effects and 
contraindications (``major statement'') 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

[[Page 15387]]

connection with the broadcast presentation, must contain a brief 
summary of all necessary information related to side effects and 
contraindications.
    (ii) Clear, conspicuous, and neutral manner. Advertisements for 
prescription drugs intended for use by humans presented directly to 
consumers in television or radio format must present the major 
statement in a clear, conspicuous, and neutral manner. A major 
statement is clear, conspicuous, and neutral if:
    (A) Information is presented in language that is readily 
understandable by consumers;
    (B) Audio information is understandable in terms of the volume, 
articulation, and pacing used;
    (C) Textual information is placed appropriately and is presented 
against a contrasting background for sufficient duration and in a size 
and style of font that allows the information to be read easily; and
    (D) The advertisement does not include distracting representations 
(including statements, text, images, or sounds or any combination 
thereof) that detract from the communication of the major statement.
* * * * *

    Dated: March 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6996 Filed 3-26-10; 8:45 am]
BILLING CODE 4160-01-S