[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
[email protected].
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 [email protected]. 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