[Federal Register Volume 88, Number 223 (Tuesday, November 21, 2023)]
[Rules and Regulations]
[Pages 80958-80984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25428]


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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 a Clear, Conspicuous, and Neutral Manner in 
Advertisements in Television and Radio Format

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing a final rule to amend its regulations concerning direct-to-
consumer (DTC) advertisements (ads) for human prescription drugs 
presented in television or radio format and stating the name of the 
drug and its conditions of use (DTC TV/radio ads). Specifically, the 
final rule implements a requirement of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), added by the Food and Drug Administration 
Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the 
major statement relating to side effects and contraindications must be 
presented in a clear, conspicuous, and neutral manner. As directed by 
FDAAA, FDA is establishing standards to determine whether the major 
statement in DTC TV/radio ads is presented in a clear, conspicuous, and 
neutral manner.

DATES: This rule is effective May 20, 2024. The compliance date of this 
rule is November 20, 2024.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: 
    With regard to human drug products: Suzanna Boyle, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1200, [email protected].
    With regard to human biological products: Anne Taylor, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.
    With regard to the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Overview of Direct-to-Consumer Prescription Drug Advertising 
and Its Regulation
    B. History of the Rulemaking
    C. Summary of Comments to the Proposed Rule
    D. General Overview of Final Rule and Changes to the Proposed 
Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. General Comments
    C. Research Studies--Comments and FDA Response
    D. The Major Statement--Comments and FDA Response
    E. Standards To Determine a Clear, Conspicuous, and Neutral 
Manner--General Comments and FDA Response
    F. Consumer/Audience--Comments and FDA Response
    G. Proposed Standard #1 (Final Standard #1) (Language)--Comments 
and FDA Response
    H. Proposed Standard #2 (Final Standard #2) (Audio)--Comments 
and FDA Response
    I. Proposed Standard #3 (Final Standard #4) (Presentation of 
Text)--Comments and FDA Response
    J. Proposed Standard #4 (Final Standard #5) (Elements That 
Interfere)--Comments and FDA Response
    K. Dual Modality (Final Standard #3)--Comments and FDA Response
    L. First Amendment Freedom of Speech--Comments and FDA Response
    M. Role of Healthcare Professional--Comments and FDA Response
    N. Costs--Comments and FDA Response
    O. Enforcement--Comments and FDA Response
VI. Effective/Compliance Dates
VII. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Final Rule

    This final rule implements a statutory requirement that in human 
prescription drug advertisements presented directly to consumers in 
television or radio format and stating the name of the drug and its 
conditions of use (DTC TV/radio ads), the major statement relating to 
side effects and contraindications (major statement) (Ref. 1) must be 
presented in a clear, conspicuous, and neutral manner. (As used in this 
document, unless specifically stated otherwise, references to DTC ads 
and similar terms encompass ads for human prescription drugs only.) In 
enacting that requirement, Congress directed FDA to issue regulations 
establishing standards for determining whether a major statement is 
presented in a clear,

[[Page 80959]]

conspicuous, and neutral manner. The final rule establishes five 
standards that, independently and collectively, help ensure that the 
major statement is presented in a clear, conspicuous, and neutral 
manner. This rule does not change the content of the major statement.
    This rule is an incremental addition to a longstanding body of 
prescription drug advertising regulations. The statute and regulations 
regarding DTC ads have long required that, with limited regulatory 
exceptions, prescription drug ads include information about the 
advertised drug's risks as well as its effectiveness. This final rule 
complements the longstanding requirements for including risk 
information in prescription drug ads, setting standards for the manner 
of presentation of the major statement of side effects and 
contraindications in DTC TV/radio ads to help ensure that this risk 
information is presented effectively--that is, in a way that helps 
consumers notice, attend to, and understand the drug's risks.
    By helping consumers notice, attend to, and understand a drug's 
risks, the final rule directly advances two substantial Government 
interests. First, the measures required by the final rule help ensure 
that DTC TV/radio ads convey a truthful and non-misleading net 
impression about the advertised drug, including its risks. Second, 
these measures help ensure that consumers are better informed when they 
participate in healthcare decision making. Although prescription drugs 
must be prescribed by a healthcare provider (HCP) and cannot be 
accessed by consumers directly, consumers make decisions that have a 
critical effect on health and well-being, such as whether to fill a 
prescription, whether to initiate taking the prescribed drug, and 
whether to continue taking the drug in adherence to a prescribed 
regimen. The clear, conspicuous, and neutral presentation of risk 
information in DTC TV/radio ads, in addition to benefit information, 
helps ensure that these ads convey a truthful and non-misleading net 
impression about the advertised drug and that consumers are better 
informed when they participate in healthcare decision making.

B. Summary of the Major Provisions of the Final Rule

    This final rule specifies five standards that, independently and 
collectively, help ensure that the major statement is presented in a 
clear, conspicuous, and neutral manner. The final rule establishes that 
the information must be presented in consumer-friendly language and 
terminology that is readily understandable. The audio information in 
the major statement must be at least as understandable as the audio 
information presented in the rest of the ad. In ads in TV format, the 
information presented in the audio portion of the major statement must 
also be presented concurrently in text for a sufficient duration to 
allow it to be read easily. In ads in TV format, the information in 
text must be formatted such that the information can be read easily. 
The ad must not include audio or visual elements during the 
presentation of the major statement that are likely to interfere with 
comprehension of the major statement.

C. Legal Authority

    This final rule amends FDA's prescription drug advertising 
regulations to be consistent with the current requirements of the FD&C 
Act, as amended by FDAAA, that in human prescription drug ads 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. In addition, FDAAA directed FDA 
to establish standards for determining whether the major statement in 
DTC TV/radio ads is presented in a clear, conspicuous, and neutral 
manner--and does so in this rule. Furthermore, this rule is authorized 
by various provisions of the FD&C Act.

D. Costs and Benefits

    The benefits of this final rule stem from and include helping 
consumers notice, attend to, and understand the major statement in DTC 
TV/radio ads. The standards in the final rule help to ensure that DTC 
TV/radio ads convey a truthful and non-misleading net impression about 
the advertised drug and help ensure that consumers are better informed 
when they participate in healthcare decision making. We discuss the 
benefits qualitatively.
    The costs of this final rule include the cost to read and 
understand the rule, to revise a firm's \1\ standard operating 
procedures, and to revise TV and radio ads during the transition period 
leading up to the compliance date. We also expect there to be modest 
ongoing costs for industry to review future DTC TV/radio ads to ensure 
that these advertisements comply with this final rule and an ongoing 
opportunity cost related to a potential change in the relative 
allocation of time within the ad between the presentation of the major 
statement and the presentation of other content. The total present 
value of costs over a 10-year time horizon ranges from $104.8 million 
to $331.8 million, with a primary estimate of $218.3 million, at a 7 
percent discount rate; the present value ranges from $123.8 million to 
$393.0 million, with a primary estimate of $258.4 million, at a 3 
percent discount rate. Annualized costs over a 10-year time horizon 
range from $14.9 million to $47.2 million, with a primary estimate of 
$31.1 million, at a 7 percent discount rate; annualized costs over a 
10-year time horizon range from $14.5 million to $46.1 million, with a 
primary estimate of $30.3 million, at a 3 percent discount rate.
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    \1\ In this document, ``firm'' refers to manufacturers, packers, 
and distributors of prescription drugs and all of their 
representatives, including both individuals and corporate entities.
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II. Table of Abbreviations/Commonly Used Acronyms in This Document

------------------------------------------------------------------------
     Abbreviation/acronym                    What it means
------------------------------------------------------------------------
CBER.........................  Center for Biologics Evaluation and
                                Research.
CDER.........................  Center for Drug Evaluation and Research.
CFR..........................  Code of Federal Regulations.
CMP..........................  Civil Monetary Penalties.
DTC..........................  Direct-to-Consumer.
FDA..........................  United States Food and Drug
                                Administration.
FDAAA........................  Food and Drug Administration Amendments
                                Act of 2007.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FR...........................  Federal Register.
FTC..........................  Federal Trade Commission.
HCP..........................  Healthcare provider, healthcare
                                professional, healthcare practitioner.

[[Page 80960]]

 
OMB..........................  Office of Management and Budget.
SUPERs.......................  Superimposed text.
TV...........................  Television.
U.S.C........................  United States Code.
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III. Background

A. Overview of Direct-to-Consumer Prescription Drug Advertising and Its 
Regulation

    American consumers encounter ads for an enormous variety of goods 
and services, each ad seeking to attract their attention, pique their 
interest, and ultimately drive demand for the advertised product or 
service. But few ads provide information about products as important as 
prescription drugs. Prescription drugs are integral to healthcare, and 
decisions about their use can have critical effects on health and well-
being. These decisions about prescription drug use not only impact each 
individual patient's health and well-being but also affect others, 
including family, friends, and caregivers.
    Of course, by definition, prescription drugs cannot be accessed 
directly by consumers; they must be prescribed by a practitioner 
licensed by law to administer such drugs (commonly referred to as a 
healthcare professional, provider, or practitioner, here referred to as 
HCPs). But the billions of dollars drug manufacturers spend annually to 
promote their prescription drugs directly to consumers through TV ads 
and other media demonstrate recognition that consumers make critical 
choices related to treatment with prescription drugs. For example, 
consumers decide whether to make an initial appointment with an HCP, 
whether to ask the HCP about a particular drug, whether to fill a 
prescription, whether to take the drug, and whether to continue taking 
it in adherence to the prescribed regimen.
    These decisions are informed by what consumers know about a drug, 
starting with the most basic awareness of the drug's availability and 
the health condition(s) for which it is approved. For U.S. consumers, 
that knowledge is often derived from DTC ads, a major source of 
information about human prescription drugs (Refs. 2 to 6). Analysis of 
submissions by firms to FDA's Center for Drug Evaluation and Research 
(CDER) of ads that the firms identify as DTC radio or TV ads, together 
with spending data, illustrates the widespread use of these formats for 
prescription drug advertising. For example, in 2007, when the clear, 
conspicuous, and neutral manner requirement was enacted, firms 
identified 74 new DTC radio ads in submissions to FDA's CDER, spending 
$30 million on all prescription drug DTC radio ads in that year (Ref. 
7). In 2020, firms identified 56 new DTC radio ads in submissions to 
FDA's CDER, while spending on all prescription drug DTC radio ads 
increased to $57.4 million for that same year (Ref. 8).
    TV ads for prescription drugs are even more prevalent, and attract 
enormous absolute and relative spending. In 2007, firms identified 434 
new DTC TV ads in submissions to FDA's CDER, and the reported 
expenditure for all prescription drug DTC TV ads in that year was $2.87 
billion of a total of $4.77 billion spent on DTC advertising (Ref. 7). 
In 2020, firms identified 564 new DTC TV ads in submissions to FDA's 
CDER, and the reported expenditure for all prescription drug DTC TV ads 
that year was $4.58 billion of a total of $6.58 billion spent on DTC 
advertising (Ref. 9). While the number of TV ads has increased, a 
published analysis of DTC TV ads found that ads in 2016 presented many 
of the same elements (e.g., use of emotional appeals, focus on drug 
benefits over health information) as ads in a 2004 analysis, indicating 
a general consistency in such ads over time (Ref. 10).
    Prescription drug firms have long maintained that their DTC ads 
respond to consumer desire for information about prescription drugs 
(Ref. 11). However, in light of their pervasiveness, consumers are 
likely to be exposed to DTC TV/radio ads even if they are not actively 
seeking information about any prescription drug.
    Evidence shows that DTC ads inform important consumer decisions 
about healthcare. For example, surveys indicate that DTC advertising 
influences whether consumers seek more information about a drug, decide 
to visit and discuss an advertised drug with an HCP, or decide not to 
see an HCP (Refs. 12 to 17). This is one reason why Congress enacted 
the requirement in section 502(n) of the FD&C Act addressed by this 
final rule, requiring the major statement of side effects and 
contraindications in DTC TV/radio ads to be presented in a clear, 
conspicuous, and neutral manner. As one lead sponsor explained during 
Senate floor consideration, a motivation for the legislation was 
``[r]esearch . . . show[ing] that people are more likely to go to the 
doctor, ask thoughtful questions, and discuss sensitive health issues 
with their doctors as a result of DTC ads.'' See 153 Cong. Rec. S5631 
(May 7, 2007) (statement of Sen. Roberts).
    Like all advertisers, prescription drug firms have ample business 
incentives to present their products in a positive light to potential 
consumers. But those business incentives do not assure clear 
communication of the advertised drug's negative attributes to 
consumers. Firms' lack of business incentives, combined with DTC ads' 
ability to inform and influence consumer participation in healthcare 
decision making, points to the need for Government regulation of 
prescription drug ads in particular. Ensuring that DTC ads that provide 
benefit information about prescription drugs also effectively 
communicate risk information is particularly important because the 
effective presentation of risk information is critical to helping to 
ensure that DTC TV/radio ads convey a truthful and non-misleading net 
impression about the advertised drug, including its risks, and that 
consumers are better informed when they participate in healthcare 
decision making, as described elsewhere in this document. Further, the 
consumer is uniquely positioned to know about particular, personal 
circumstances or limitations (e.g., other medicines and supplements 
being taken, constraints on time or other resources, allergies, 
preferences) that are important factors in decision making about 
prescription drug treatments. See Ref. 18 noting the changing role of 
consumer as processor of health information. When taking into account 
their own specific circumstances and what they know about a 
prescription drug, a consumer decides whether they will accept 
undesirable side effects in light of health benefits, whether they will 
devote the necessary ongoing attention to monitoring and management to 
optimize net outcomes, or even whether they need to avoid or prefer to 
avoid a drug completely because the risks for that individual are too 
great. As further explained below, the measures in this rule join other 
longstanding

[[Page 80961]]

requirements that help remedy the lack of business incentive for 
prescription drug firms to effectively communicate the risks of their 
products to consumers, and thus, the standards established in this 
rule, independently and collectively, advance the substantial 
Government interests in helping to ensure that DTC TV/radio ads convey 
a truthful and non-misleading net impression about the advertised drug 
and that consumers are better-informed when they participate in 
healthcare decision making.
1. Government Interests in This Regulation
    For DTC TV/radio ads, the measures in this rule enhance the manner 
of presentation of risk information to increase the likelihood that 
consumers will notice, attend to, and understand the major statement in 
these ads, which conveys the drug's major side effects and 
contraindications. Improving consumer understanding of these risks 
helps ensure that an ad conveys a truthful and non-misleading net 
impression about the advertised drug. And improving consumer 
understanding also helps ensure that consumers are better-informed when 
they participate in healthcare decision making.
    As the Supreme Court has recognized, ``there is no question that 
[the Government's] interest in ensuring the accuracy of commercial 
information in the marketplace is substantial'' (Edenfield v. Fane, 507 
U.S. 761, 769 (1993)). Consistent with this overall interest for all 
advertising, this rule helps ensure that DTC TV/radio ads communicate 
risk so that they convey a truthful and non-misleading net impression 
about the advertised drug. This purpose was also identified by an 
author of the statutory provision underlying this regulation. See 153 
Cong. Rec. S5631 (May 7, 2007) (statement of Sen. Roberts during floor 
consideration) (``My amendment requires that major statements about a 
drug's side effects, contraindications, and effectiveness in television 
or radio ads be presented in a clear and conspicuous manner so as not 
to mislead the public.''). In addition, although Federal law does not 
prohibit DTC advertising of any legally marketed drug, research 
indicates that some consumers erroneously believe that drugs that have 
serious side effects cannot be advertised to consumers (Ref. 19). While 
this rule does not change the content of the major statement in 
prescription drug ads, presenting the major statement in a clear, 
conspicuous, and neutral manner will help consumers understand if there 
are serious risks associated with a drug. Thus, this rule seeks to help 
ensure that DTC ads communicate risk information in a manner that helps 
consumers notice, attend to, and understand the drug's risks.
    The Government also has a substantial interest in promoting 
consumer understanding of a prescription drug's risks in order to help 
ensure that consumers are better informed when they participate in 
healthcare decision making at each of the many important healthcare 
decision points already described, taking account of their individual 
circumstances. See, e.g., American Hosp. Ass'n v. Azar, 983 F.3d 528, 
538 (D.C. Cir. 2020) (``providing consumers with factual price 
information to facilitate more informed health care decisions''); 
CTIA--The Wireless Ass'n v. City of Berkeley, 928 F.3d 832, 846 (9th 
Cir. 2019) (informing consumers regarding radiation emissions from cell 
phone and methods of avoiding excessive exposure); Discount Tobacco 
City & Lottery, Inc. v. United States, 674 F.3d 509, 567 (6th Cir. 
2012) (``effectively communicat[ing] the associated health risks [of 
tobacco products] so that consumers possess accurate, factual 
information when deciding whether to buy tobacco products''); Nat'l 
Elec. Mfrs. Ass'n v. Sorrell, 272 F.3d 104, 115 (2d Cir. 2001) 
(``increasing consumer awareness of the presence of mercury in a 
variety of products'').
    Ensuring that a drug's specific risks are effectively communicated 
in DTC TV/radio ads helps inform consumers--another purpose identified 
by an author of the legislation underlying this rulemaking. See 153 
Cong. Rec. S5645 (May 7, 2007) (statement of Sen. Harkin) (stating that 
the amendment seeks ``to help the FDA and the companies to provide 
better information so that consumers can make real choices''). This 
regulation, by helping to assure that ads that address a prescription 
drug's benefits also facilitate understanding of risks, helps consumers 
when they are exploring healthcare options.
    Improving consumer understanding of an advertised prescription 
drug's risks to better inform those consumers when they participate in 
healthcare decision making is especially important in the American 
healthcare environment. Evidence indicates that HCPs have limited time 
with patients (Refs. 20 to 23) and discussions with patients are only 
one among varied HCP duties that may include clinical care, research, 
mentoring, teaching, electronic health recordkeeping, and other 
administrative duties (Refs. 24 and 25). Moreover, as previously noted, 
consumers have information about their individual circumstances that 
may be relevant, or even critical, to any decision about use of a 
particular prescription drug. Helping ensure consumers have the 
information they need to formulate appropriate questions or bring up 
relevant information about their personal circumstances during 
interactions with HCPs helps consumers make productive use of those 
interactions.
2. Consistency With Longstanding Statutory and Regulatory Measures 
Regarding Prescription Drug Risk Presentation
    The basic concepts of the rule continue the approach taken in many 
longstanding measures applicable to prescription drug advertising and 
labeling. For example, since 1938 (for labeling) and 1976 (for 
advertising), section 201(n) of the FD&C Act has reflected the 
principle that disclosing material facts that include the 
``consequences'' of using the drug to which labeling or advertising 
relates is key to ensuring that such communications are not misleading.
    Moreover, the more precise principle that when drug manufacturers 
choose to advertise prescription drugs, those ads must provide risk 
information was recognized with the 1962 enactment of section 502(n) of 
the FD&C Act, specifying that prescription drug ads must include ``a 
true statement of. . .other information in brief summary relating to 
side effects, contraindications and effectiveness as shall be required 
in regulations . . . .'' Accordingly, a specific regulatory requirement 
to convey a prescription drug's risks in its advertising has been in 
place since 1963. See 28 FR 6375 at 6376 (June 20, 1963). And since 
1969, the prescription drug advertising regulations have specifically 
addressed the use of a statement of the advertised drug's major side 
effects and contraindications in TV and radio advertising. See 34 FR 
7802 (May 16, 1969). Similarly, many drug firms have also long 
acknowledged that DTC ads that convey benefit information should also 
contain risk information (Ref. 11).
    After industry's initial forays into DTC prescription drug 
advertising in the early 1980s, FDA confirmed that DTC advertising was 
likewise subject to these established prescription drug advertising 
regulations. See 50 FR 36677 at 36678 (September 9, 1985) and Sec.  
202.1(e)(1) (1985). This was the regulatory framework that was in place 
in 2007, when Congress amended the

[[Page 80962]]

underlying statutory provision in section 502(n) of the FD&C Act to 
codify the importance of ads effectively communicating risk to 
consumers by further specifying that this ``major statement relating to 
side effects and contraindications'' in human prescription drug 
advertisements presented directly to consumers in television or radio 
format and stating the name of the drug and its conditions of use, be 
presented in a clear, conspicuous, and neutral manner.
    The specific ``clear, conspicuous, and neutral manner'' provision 
that this regulation addresses is also part of a longstanding line of 
statutory and regulatory provisions that help ensure that an inadequate 
manner of presentation does not undermine required disclosures about 
prescription drugs. See, e.g., 21 U.S.C. 352(c) (enacted by Pub. L. 75-
717 (June 25, 1938)), establishing misbranding if prominence, 
conspicuousness, and terms used to present required elements of 
labeling for drugs and devices are not sufficient to ``render it likely 
to be read and understood by the ordinary individual under customary 
conditions of purchase and use.'' In fact, provisions for presenting 
required information clearly and prominently have been a part of 
requirements for prescription drug advertising since the first such 
regulations were issued. See 28 FR 6375 at 6377 (initial regulations 
issued under section 502(n) of the FD&C Act, including 21 CFR 1.105(i), 
requiring information concerning side effects and contraindications to 
appear ``in reasonably close association with the information 
concerning effectiveness'' with ``the same relative degree of 
prominence as the information concerning effectiveness, taking into 
account all pertinent factors, including typography, layout, contrast, 
and other printing features.''); see also current Sec.  
202.1(e)(7)(viii).
    This rulemaking complements these longstanding prescription drug 
advertising requirements. This rule brings additional clarity to 
existing provisions about the major statement in DTC TV/radio ads by 
providing information on how that major statement must sound and (in 
the case of TV ads) look.
    In sum, this rulemaking is an important incremental measure, adding 
to a longstanding body of legal requirements addressing effective 
communication of risk information about prescription drugs in consumer-
directed promotional communications. The rule helps ensure that DTC TV/
radio ads convey a truthful and non-misleading net impression about the 
advertised drug and helps ensure that consumers are better informed 
when they participate in healthcare decision making.

B. History of the Rulemaking

    In the proposed rule (Federal Register of March 29, 2010 (75 FR 
15376)), we proposed to amend our regulations regarding DTC TV/radio 
ads in accordance with section 901(d)(3) of FDAAA (see 21 U.S.C. 
352(n)). Specifically, we proposed to implement provisions of FDAAA 
requiring that in human prescription drug advertisements 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.
    We proposed the following four standards for determining whether 
the major statement in these ads is presented in the statutorily 
required manner:
    #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.
    #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.
    We also solicited comment on a potential fifth standard to require 
that in TV ads, the major statement be presented simultaneously in both 
audio and visual portions of the ad--a practice known as dual modality.
    In developing these proposed standards, FDA considered standards 
developed by other Federal Agencies, including the Federal Trade 
Commission (FTC), the Department of the Treasury, the Commodity Futures 
Trading Commission, and the Securities and Exchange Commission, for 
determining whether disclosures in TV/radio ads, as well as disclosures 
in other contexts, are ``clear and conspicuous'' (75 FR 15376 at 15377-
15379). Then, as now, the Agency considered these standards to be 
highly relevant because they aim to ensure that required disclosures 
are effectively presented so that consumers are not misled about the 
attributes of the product or service that is the subject of the 
communication. As discussed in section III.A.1 of this document, FDA 
has a similar interest in ensuring that DTC TV/radio ads convey a 
truthful, non-misleading net impression about the advertised drug.
    FDA noted in the preamble of the proposed rule that these other 
Federal standards revealed the widespread incorporation of common 
themes, which FDA in turn incorporated in its own proposed standards, 
and now incorporates in its final standards, because they are all 
factors that contribute to whether the audience will notice, attend to, 
and understand the risk information in the major statement (75 FR 15376 
at 15378-15379). These themes were: ``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'' (75 FR 15376 at 15378). The language 
of the standards from other Federal Agencies cited in the proposed rule 
and the themes incorporated by those other Federal standards remain 
unchanged.\2\
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    \2\ The definition of ``clear and conspicuous'' in one 
regulation cited in the proposed rule, 12 CFR 40.3, is now part of 
12 CFR 1016.3.
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    In the proposed rule, FDA also noted that its proposed standards 
were consistent with factors described and discussed in its draft 
guidance entitled ``Presenting Risk Information in Prescription Drug 
and Medical Device Promotion'' (May 2009) (draft Risk Guidance; Ref. 
26) (available at https://www.fda.gov/media/76269/download) (75 FR 
15376 at 15379). That draft guidance reflects consideration of a broad 
body of social science research into human cognition and factors that 
impact attention and comprehension.
    The Agency also noted in the proposed rule that it was unaware of 
any previous standards or regulations concerning the definition of 
``neutral manner'' in the context of required disclosures but 
considered ``neutral manner'' to mean ``unbiased manner'' of 
presentation and thus proposed standards accordingly. The Agency 
suggested, ``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'' (75 FR 15376 at 15380). As 
part of the overall

[[Page 80963]]

establishment of standards for effectively communicating necessary risk 
information in a clear, conspicuous, and neutral way, we requested 
comments on standards to establish what is ``neutral'' (75 FR 15376 at 
15380).
    In the proposed rule (75 FR 15376 at 15379), we noted that FDA had 
conducted a study on the impact of certain types of visual distraction 
on consumer understanding of risk and benefit information in DTC TV ads 
for prescription drugs (referred to in this document as the Distraction 
Study), the results of which were at that time still undergoing 
analysis (and, consequently, were not the basis of any specific 
provision in the proposed rule). FDA acknowledged the limitations of 
this study, but because FDA believed it could be relevant to the 
rulemaking, announced plans to place the report of the results into the 
docket for the proposed rule with opportunity for comment. Accordingly, 
in the Federal Register of January 27, 2012 (77 FR 4273), we announced 
the addition of the Distraction Study report to the docket (Ref. 27), 
and we reopened the rulemaking comment period until February 27, 2012, 
to provide an opportunity for interested parties to comment on the 
study as it relates to the proposed standards (Docket No. FDA-2009-N-
0582). In the Federal Register of March 29, 2012 (77 FR 16973), we 
reopened the comment period for the rulemaking proceeding again until 
April 9, 2012, in response to a request for more time to submit 
comments to the Agency on the Distraction Study report as it related to 
the proposed standards.
    The Distraction Study examined three factors that might influence 
viewers' understanding of the risk information presented in the audio 
portion of a TV ad. This research evaluated the effects of:
     Presence or absence of superimposed text (SUPERs) that 
concurrently presented verbatim, key words and phrases from the audio 
presentation of risk;
     Variations in the positive (affective) tone of visual 
images; and
     Visual information that was either inconsistent or 
consistent with the audio risk information.
    The results of the Distraction Study indicate that presenting the 
same risk information visually (i.e., in SUPERs) and in audio at the 
same time (dual modality) improves consumers' understanding of the risk 
information. The Distraction Study did not find support for the 
hypotheses that understanding of the risk information is adversely 
influenced by concurrently presenting positively toned visual images or 
by concurrently presenting information in visuals that is inconsistent 
with the risk information presented in audio (Ref. 27). While the 
Distraction Study and its results were a consideration during the 
formulation of the standards in this final rule, they were neither the 
sole justification for, nor the only information considered in, the 
development of any of the proposed or final standards.
    FDA based the standards in the proposed rule on scientific 
research, literature, and existing Government standards, all of which 
continue to be relevant for the final rule. Research findings 
supporting the proposed rule's standards--including research findings 
on dual modality and distraction--were available during the public 
comment periods and have been subsequently corroborated by additional 
research, including research supporting that comprehension and recall 
is increased when information is provided in both audio and text and 
also when information is presented without distraction. In this final 
rule, the fundamental concepts remain the same as those articulated in 
the proposed rule. Evolving technologies have allowed for DTC TV/radio 
ads to be presented on a broader range of devices and disseminated via 
a broader range of platforms since the issuance of the proposed 
rule.\3\ However, from an informal review of ads firms recently 
submitted to FDA in accordance with regulatory requirements (21 CFR 
314.81(b)(3)(i) and 601.12(f)(4)), FDA observes that firms have not 
developed distinct ads for dissemination on these new devices and 
platforms and that DTC TV/radio ads remain essentially the same. 
Moreover, fundamental attributes of communication that impact the 
likelihood that audiences will notice, attend to, and comprehend 
information, which the standards in the proposed and final rules 
concentrate on, do not turn on the delivery technology.
---------------------------------------------------------------------------

    \3\ See, e.g., Ipsos, ``Half of American TV viewers watch 10 or 
more hours of TV during the week,'' Report, July 28, 2021, available 
at https://www.ipsos.com/en-us/news-polls/american-tv-viewing-habits-2021, accessed September 7, 2023; Leiner, D.J. and N.L. 
Neuendorf, ``Does Streaming TV Change Our Concept of Television?'' 
Journal of Broadcasting & Electronic Media, 66(1):153-175, 2022. 
doi:10.1080/08838151.2021.2013221; Radioworld, ``How Technology 
Helps Radio and Its Listeners,'' April 9, 2019, available at https://www.radioworld.com/columns-and-views/guest-commentaries/rab-audio-technology-helps-radio, accessed September 7, 2023.
---------------------------------------------------------------------------

    We recognize the passage of time between the closure of the last 
comment period on the proposed rule and the issuance of this final 
rule, which resulted in large part from competing demands for limited 
Agency resources, such as repeated redirection of personnel into 
emergency operations for natural disasters, the opioid epidemic, and 
infectious disease outbreaks including Ebola, Zika, and the COVID-19 
pandemic. Despite this passage of time, FDA concludes that this 
rulemaking is both procedurally and substantively sound. A central 
purpose of notice-and-comment rulemaking is to obtain public input, see 
Make the Rd. N.Y. v. Wolf, 962 F.3d 612, 634 (D.C. Cir. 2020) and 
United States v. Cain, 583 F.3d 408, 420 (6th Cir. 2009). The Agency 
has provided three public comment periods, offering meaningful 
opportunities for any interested persons to comment on the rulemaking 
and the bases for the standards laid out in this rulemaking.\4\ Indeed, 
no parties have requested additional opportunity for comment since 
closure of the last comment period, even though the Agency's plans to 
issue a final rule have been consistently made public through the 
Unified Agenda since 2017. Moreover, as noted above, the Agency has 
determined that there are no material changes in the fundamental 
concepts, relevant facts (including evolving technologies), scientific 
research, literature, or existing Government standards underlying the 
rule. For these reasons, FDA concludes that it is appropriate to issue 
this final rule without offering a fourth opportunity for public 
comment.
---------------------------------------------------------------------------

    \4\ See also Little Sisters of the Poor Saints Peter & Paul Home 
v. Pennsylvania, 140 S. Ct. 2367, 2385, (2020) (The Administrative 
Procedure Act (APA) prescribes the ``maximum procedural requirements 
that an agency must follow in order to promulgate a rule.'') 
(internal quotation marks omitted); Sanofi-Aventis US LLC v. HHS, 58 
F.4th 696, 706 (3d Cir. 2023) (``all the APA requires of an agency 
before publishing a final rule is (1) putting a notice of proposed 
rulemaking in the Federal Register, (2) accepting comments on that 
proposal, and (3) considering those comments. See 5 U.S.C. 553(b)-
(c).'')
---------------------------------------------------------------------------

C. Summary of Comments to the Proposed Rule

    There were three public comment periods for the proposed rule. In 
total, FDA received over 70 submissions from consumers, public interest 
or consumer groups, trade and industry associations, healthcare 
providers, and drug firms. Overall, the majority of comments express 
support for the proposed rule. Several comments request that FDA edit 
the proposed rule, provide clarification, or provide more detail. 
Several comments suggest that FDA undertake additional research before 
finalizing the rule. We address these and other comments throughout 
this document.

[[Page 80964]]

D. General Overview of Final Rule and Changes to the Proposed Rule

    This final rule implements a FDAAA requirement (codified in 21 
U.S.C. 352(n)) that in human prescription drug advertisements 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. This statutory requirement has 
been in effect since March 25, 2008. In line with other Government 
standards, findings from scientific research and literature, and the 
proposed rule, this final rule establishes standards for determining 
whether the major statement in these ads is presented in a clear, 
conspicuous, and neutral manner.
    We discuss the following:
     In the final rule, we do not address ``neutral'' 
separately from the overall concept of a ``clear, conspicuous, and 
neutral manner'' of presentation, nor do we associate that attribute 
exclusively with any single standard. Rather, we conclude that the 
final standards, independently and collectively, contribute to a clear, 
conspicuous, and neutral manner of presentation.
     Proposed standard #1 (final standard #1; Sec.  
202.1(e)(1)(ii)(A)): ``Information is presented in language that is 
readily understandable by consumers.'' The final standard specifies 
that the major statement must be presented in consumer-friendly 
language and terminology that is readily understandable.
     Proposed standard #2 (final standard #2; Sec.  
202.1(e)(1)(ii)(B)): ``Audio information is understandable in terms of 
the volume, articulation, and pacing used.'' The final rule clarifies 
that the audio information in the major statement must be at least as 
understandable as the audio information presented in the rest of the ad 
in terms of the volume, articulation, and pacing used.
     Proposed potential standard #5 (final standard #3; Sec.  
202.1(e)(1)(ii)(C)): The final rule includes a standard requiring that 
for ads in TV format, the major statement be presented concurrently 
using both audio and text (dual modality). To achieve dual modality: 
(1) either the text displays the verbatim key terms or phrases from the 
corresponding audio, or the text displays a verbatim complete 
transcript of the corresponding audio; and (2) the text is displayed 
for a sufficient duration to allow it to be read easily. For the 
purposes of this standard, the duration is considered sufficient if the 
text display begins at the same time and ends at approximately the same 
time as the corresponding audio.
     Proposed standard #3 (final standard #4; Sec.  
202.1(e)(1)(ii)(D)): ``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.'' The final rule removes the duration requirement from this 
standard, including it instead in final standard #3, and clarifies that 
this standard applies to the text portion of the major statement in ads 
in television format. For clarity, we also reorganized the phrasing of 
this standard.
     Proposed standard #4 (final standard #5; Sec.  
202.1(e)(1)(ii)(E)): ``The advertisement does not include distracting 
elements (including statements, text, images, or sounds or any 
combination thereof) that detract from the communication of the major 
statement.'' The final rule revises the standard to specify that, in 
order to satisfy it, during presentation of the major statement, the ad 
does not include audio or visual elements, alone or in combination, 
that are likely to interfere with comprehension of the major statement.
    We also made the following non-substantive editorial changes on our 
own initiative:
     Section 202.1: Relocated text that defines prescription 
drug for purposes of this section (previously included in Sec.  
202.1(e)(1)). Within this definition, replaced the phrase ``drugs for 
use by man'' with the phrase ``drugs intended for use by humans.''
     Section 202.1(e): Divided information into subordinate 
paragraphs for clarity, ease of reading, and plain language.
     Section 202.1(e)(1)(i): Added subparagraphs for ease of 
reading and reference to Sec.  202.1(e)(1)(ii)(C) for clarity. Replaced 
``approved or permitted package labeling'' with ``approved or permitted 
product labeling.''
     Section 202.1(e)(1)(ii): Revised introductory language to 
reflect that it is the manner of presentation of the major statement 
that is ``clear, conspicuous, and neutral,'' if the standards that 
follow are met.

IV. Legal Authority

    This final rule amends Sec.  202.1 to be consistent with the 
current requirements of section 502(n) of the FD&C Act, as amended by 
section 901(d)(3) of FDAAA, which establishes a requirement that in 
human prescription drug ads 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. In addition, FDA was directed by FDAAA (see section 
901(d)(3)(B)) to establish standards for determining whether the major 
statement in DTC TV/radio ads is presented in a clear, conspicuous, and 
neutral manner--and does so in this rule. Furthermore, this rule is 
authorized by various statutory provisions, including sections 201, 
301, 502, 505, 512, and 701 of the FD&C Act.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    During the initial comment period (March 29 to June 28, 2010), FDA 
received more than 30 submissions on the proposed rule from consumers, 
public interest groups, trade associations, and the drug industry. When 
we reopened the comment period to allow for comment on the Distraction 
Study report as it relates to the proposed standards (January 27 to 
February 27, 2012, and March 29 to April 9, 2012), we received nearly 
40 additional submissions.
    In sections V.B through V.O of this document, we describe the 
comments received on the proposed rule and provide our responses. To 
make it easier to identify the comments and our responses, the word 
``Comment,'' in parentheses, appears before the comment's description, 
and the word ``Response,'' in parentheses, appears before our response. 
We have numbered each comment to help distinguish between different 
comments. We have grouped similar comments together under the same 
number and, in some cases, we have separated different subjects 
discussed in the same comment and designated them as distinct comments 
for purposes of our responses. The number assigned to each comment or 
comment topic is purely for organizational purposes and does not 
signify the comment's value or importance or the order in which 
comments were received. We reviewed all comments and carefully 
considered all points and perspectives. However, comments not directly 
relevant to this rulemaking were read and considered but are not 
discussed in this document.

B. General Comments

    The majority of comments, including input from industry, support 
the proposed rule, while only a few comments oppose the rule. Several

[[Page 80965]]

comments indicate that the proposed rule was an important first step, 
but even more needs to be done, and some suggest that FDA needs 
additional information or research results before the regulation is 
finalized. Various other comments request clarification on certain 
issues in the proposed rule. We address these and other comments 
throughout this document.

C. Research Studies--Comments and FDA Response

    In the proposed rule, FDA referenced a number of research studies 
relevant to the proposed standards generally and to dual modality 
specifically, and also referenced the Agency's draft Risk Guidance, 
which itself describes a well-established body of social science 
research relevant to the standards in the proposed and final rule. As 
previously described, FDA also mentioned the Distraction Study in the 
proposed rule, although its results were still undergoing analysis at 
that time, and indicated that FDA intended to add the study report to 
the docket for the rulemaking when available and provide opportunity 
for public comment, as FDA believed those study results might provide 
helpful information to consider in the rulemaking. FDA subsequently 
provided two opportunities for the public to comment on the results and 
FDA's analyses of the study and how it related to the proposed 
standards (77 FR 4273 and 77 FR 16973). Many of the comments discuss 
how the Distraction Study relates to the proposed standards. Several 
comments conclude that the results of the study directly support the 
proposed rule. However, several other comments argue that the study 
design was flawed or did not support the proposed rule. Several 
comments suggest that additional research should be conducted regarding 
distraction and the understanding of risk information by consumers.
    Comments on the results of the Distraction Study as it relates to 
proposed standard #4 regarding distracting elements that detract from 
the communication of the major statement are addressed in section V.J 
of this document (final standard #5).
    Comments pertaining to the use of dual modality in the Distraction 
Study are addressed in section V.K of this document.
    However, we briefly address several general comments related to the 
Distraction Study and other research here.
    (Comment 1) Several comments suggest that the Distraction Study did 
not examine a sufficient number of factors regarding consumers' 
understanding of risk information. One comment notes that the 
Distraction Study did not examine all four proposed standards to 
determine what would be considered clear, conspicuous, and neutral. 
Another comment points out that there are many factors beyond those 
studied that affect the assessment of risk. This comment suggests that 
FDA should examine how individual perception of risk is influenced by 
personal experiences, education level, race, gender, age, and knowledge 
of the agent creating the risk.
    Another comment states that the Distraction Study failed to address 
the full context in which the benefits and risks of prescription drugs 
are actually considered, specifically with respect to the doctor-
patient relationship. The comment argues that doctor-patient 
interaction is an integral part of the communication of benefits and 
risks for prescription drugs and thus must be considered in any 
assessment regarding risk communication. The comment suggests 
additional studies be conducted, including: (1) studies that measure 
the effect of DTC ads on the quality of any subsequent discussions 
between the patient and physician and (2) studies that measure 
comprehension of benefits and risks only after consultation with a 
physician.
    One comment suggests that FDA should consider additional research 
to determine the elements of advertising that may distract a viewer's 
attention from the major statement. Another comment notes that no study 
can account for all possible distractions consumers might face.
    (Response 1) Many of these comments appear to overstate the role of 
the Distraction Study with regard to the development of the standards 
for a clear, conspicuous, and neutral presentation of the major 
statement. We conclude that there is a strong basis for the final rule 
without the Distraction Study or the additional research that some 
comments suggest be conducted.
    The Distraction Study was designed only to examine the effects of 
three particular, pre-defined factors: the presence or absence of 
SUPERs that concurrently presented verbatim, key words and phrases from 
the audio presentation of risk; variations in the positive (affective) 
tone of visual images; and visual information that was either 
inconsistent or consistent with the audio risk information. Consistent 
with the limitations of the Distraction Study, which FDA acknowledged 
in the proposed rule (see 75 FR 15376 at 15379), neither the proposed 
nor final standards for ``clear, conspicuous, and neutral manner'' of 
presentation of the major statement are contingent on its results.
    Indeed, a much larger body of social science research, together 
with disclosure standards of other Federal agencies and ordinary 
experience with situations where multiple factors compete for attention 
and may affect comprehension, informs the proposed and final standards 
for a clear, conspicuous, and neutral manner of presentation of the 
major statement. For example, the Agency's draft Risk Guidance, 
referenced in the proposed rule as describing factors consistent with 
the proposed rule's standards (75 FR 15376 at 15379), included 
cognitive science research that predated the Agency's Distraction Study 
and demonstrated that, while there is some variation based on 
expertise, all people have limits on the amount of information they can 
think through and process at one time (see draft Risk Guidance, at p. 6 
and fn. 20 (in this rule, Refs. 28-30)). Further, the draft guidance 
notes that to process information, a person must first pay attention to 
it. The guidance then goes on to discuss multiple factors (with 
underlying research) that contribute to whether people will pay 
attention to information, including formatting factors. Among other 
things, the draft guidance points to the well-established body of 
research that existed at the time of the proposed rule--and has been 
further corroborated since that time--that various elements can 
interfere with attention and comprehension. See, e.g., draft guidance 
p. 18, fn. 47 (in this rule, Refs. 31-33); p. 19, fns. 54 to 56 (in 
this rule, Refs. 34-36); and p. 20, fn. 61 (in this rule, Ref. 37). 
References cited in the Distraction Study report that was added to the 
docket for this rulemaking and made available for public comment 
include additional research on well-documented distracting effects of 
certain other elements. (See Distraction Study report, p. 3, fn. 1, 
citing research on scene changes (in this rule, Ref. 38) and music (in 
this rule, Ref. 39).) Similar information about social science research 
relevant to other aspects of proposed standards #1 through #4 also 
appears in the draft Risk Guidance, which the proposed rule itself 
references. The public had the opportunity to comment on the rule and 
the Agency's use of the guidance and research to inform the proposed 
standards. That research remains relevant to this final rule. The 
proposed and final standards also have a basis in disclosure standards 
of other Federal agencies (cited in the proposed rule and unchanged 
since) and ordinary

[[Page 80966]]

experience with situations where multiple factors compete for attention 
and may affect comprehension. As to dual modality, the proposed rule 
summarized a substantial body of research supportive of the utility of 
this technique, predating the Distraction Study (75 FR 15376 at 15383). 
As discussed in section V.K of this document, findings of this research 
regarding the positive impact of dual modality have been corroborated 
subsequently by the Distraction Study and other research.
    Other comments submitted to the docket for the final rule discuss 
technical details of the Distraction Study's methodology and analyses, 
rather than the standards in the rule. Sections V.J and V.K of this 
document address non-technical comments related to the Distraction 
Study's methodology as it relates to final standard #3 (section V.J) 
and final standard #5 (section V.K). However, because the Distraction 
Study was only one of many pieces of information FDA considered when 
formulating the standards for this rule, technical comments on the 
study methodology are not further discussed here.
    (Comment 2) One comment recommends that FDA develop strategies to 
ensure consumer understanding of the information contained in DTC ads, 
such as using patient focus groups to pre-approve the most common risk 
statements. Additionally, the comment suggests that other elements, 
such as font size, color, and placement, should be tested with 
consumers. The comment further suggests that FDA should conduct 
research to provide an evidence-based assessment of the proposed 
standards to ensure that they result in consumer-directed ads that 
effectively communicate risk in a clear, conspicuous, and neutral way. 
The comment concludes that this research would allow FDA to use 
quantitative, documented evidence, rather than relying on the consensus 
of expert opinion.
    Two comments also suggest that FDA should consider conducting 
research and a further analysis on how individual elements combined and 
presented together would affect the overall communication of the 
advertised drug's potential benefits and associated risks. A separate 
comment suggests that the communication of benefits and risks in DTC 
ads should be tested on an ad-to-ad basis against quantitative 
standards for evaluating comprehension and understanding among the 
intended audience.
    (Response 2) As part of the rulemaking process culminating in the 
standards in this final rule, FDA considered many resources, including 
the many comments submitted during the multiple comment periods, and 
the literature, research, and other Government standards described 
elsewhere in this document. In light of the consistency of findings in 
the research evaluating the presentation of risk information in DTC ads 
for prescription drugs from the time of the proposed rule through now, 
as well as the other Federal Government standards for clear and 
conspicuous disclosures of information cited in the proposed rule and 
still in place today, we conclude that we have sufficient information 
to finalize this regulation without additional research.

D. The Major Statement--Comments and FDA Response

    In proposed Sec.  202.1(e)(1)(i), FDA proposed to add the term 
``major statement'' in parentheses after the phrase ``major side 
effects and contraindications'' to reflect the Agency's interpretation 
that this is the meaning of the terminology used in section 502(n) of 
the FD&C Act as amended, an interpretation consistent with previous 
usage (see 75 FR 15376 and 15379; Ref. 1). We did not receive comments 
directly on this proposal and our final rule includes this provision 
for the same reasons we proposed it. We did receive comments and 
questions about the major statement in general.
    (Comment 3) One comment suggests that FDA should incorporate the 
concept of ``net impression'' (the message communicated by all elements 
of the piece as a whole) by adding the following language to the end of 
proposed Sec.  202.1(e)(1)(i): ``The adequacy of the major statement 
will be determined not just in relation to risk-related statements, but 
by the net impression of the advertisement as a whole.''
    (Response 3) We disagree with adding the suggested language. 
Although both the major statement and other components of the ad 
collectively contribute to the overall net impression, under section 
502(n) of the FD&C Act, the requirement that certain information be 
presented in a ``clear, conspicuous, and neutral manner'' applies 
specifically to ``the major statement relating to side effects and 
contraindications''--not to the ad as a whole. Because this requirement 
is specific to the presentation of the major statement, a failure to 
satisfy this requirement cannot be remedied by the presentation of 
statements in other portions of the ad. For this reason, we decline to 
add the proposed language, which would allow for the interpretation 
that an inadequately presented major statement can be made adequate by 
statements in other parts of the ad.
    FDA will, however, continue to evaluate the net impression created 
by a DTC TV/radio ad in determining whether that ad is false or 
misleading. FDA considers net impression as well as evaluates specific 
risk-related statements in these ads. It is consistent with this 
approach to issue regulations that recognize the need for the major 
statement to satisfy, on its own, specific statutory requirements. 
Furthermore, presenting the major statement in a clear, conspicuous, 
and neutral manner should help ensure DTC TV/radio ads convey a 
truthful and non-misleading net impression about the advertised drug.
    (Comment 4) One comment recommends that the rule specify the 
location of the major statement in the ad. This comment suggests that 
the major statement should not appear in the middle of the ad ``where 
it can be bookended by benefit information and is least likely to be 
retained by consumers.''
    (Response 4) We decline to include in the final rule a provision 
specifying exactly where the major statement must appear in the ad. 
This final rule's standards for presenting the major statement in a 
clear, conspicuous, and neutral manner complement, rather than 
displace, FDA's longstanding approach to assessing whether the ad as a 
whole complies with other requirements. To ensure that the ad provides 
fair balance between information relating to side effects and 
contraindications and information relating to effectiveness of the 
drug, and to assess whether it conveys a truthful and non-misleading 
net impression about the advertised drug, FDA already considers the 
placement of risk information together with many other elements of the 
piece, including framing, signaling, themes, and other risk 
presentation factors.

E. Standards To Determine a Clear, Conspicuous, and Neutral Manner--
General Comments and FDA Response

    In this final rule, as directed by FDAAA, FDA establishes standards 
for determining whether the major statement in DTC TV/radio ads is 
presented in a clear, conspicuous, and neutral manner as required by 
section 502(n) of the FD&C Act. (Of five final standards, two apply 
only to ads in television format.)

[[Page 80967]]

    Although we believe that the five standards established by this 
rule, when applied collectively, will best help ensure that the major 
statement in a DTC TV/radio ad is presented in a clear, conspicuous, 
and neutral manner, each standard independently enhances the manner of 
presentation to increase the likelihood that consumers will notice, 
attend to, and understand the advertised drug's major side effects and 
contraindications. In the event of a stay or invalidation of any 
standard(s), those that remain in effect would continue to function 
sensibly \5\ to advance these statutory objectives and provide useful 
standards for firms to meet their existing statutory obligation. For 
example, invalidation of a standard that addresses visual aspects of 
presentation would have no effect on standards addressing audio aspects 
or terminology. Likewise, in the absence of final standard #3 (dual 
modality) or final standard #5 (audio or visual elements that are 
likely to interfere with comprehension), each of the other standards 
would continue to contribute to a clear, conspicuous, and neutral 
manner of presentation of the major statement. Therefore, it is FDA's 
intent to preserve each of the rule's standards to the fullest possible 
extent, to help advance the important Government interests described in 
section III.A.1.
---------------------------------------------------------------------------

    \5\ See, e.g., Belmont Mun. Light Dep't v. FERC, 38 F.4th 173, 
188 (D.C. Cir. 2022) (finding severability of a portion of an 
administrative action, applying the principle that severability is 
appropriate where ``the agency prefers severability to overturning 
the entire regulation'' and where the remainder of the regulation 
``could function sensibly without the stricken provision'') 
(citations omitted).
---------------------------------------------------------------------------

    As noted in section III.B of this document, in the proposed rule, 
FDA stated that it was unaware of any previous standards or regulations 
concerning the definition of ``neutral manner'' in the context of 
required disclosures and requested comment on this topic. In addition, 
in conjunction with proposed standard #4, FDA stated, ``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'' (75 FR 15376 at 15380). However, FDA did not 
intend to suggest that the ``neutral'' element of the statutory 
requirement is only explained by or only relates to proposed standard 
#4, nor did we intend to foreclose the possibility that the other 
standards contribute to achieving a manner of presentation that is 
neutral as well as clear and conspicuous. We received comments 
suggesting ways in which ``a neutral manner'' could be explained 
through the other standards. To the extent that comments discuss 
neutrality specifically with respect to any of the five final 
standards, we discuss the comments within the sections that address 
those standards.
    (Comment 5) One comment supports the maintenance of a neutral tone 
in DTC ads to ensure that consumers are able to glean as much 
information about risk as possible. One comment asks FDA to confirm 
that ``neutral'' relates to the way in which the ad presents the major 
statement as opposed to the substantive content of the major statement. 
Another comment suggests that neutrality means that the major statement 
should only include FDA-approved uses and some measure of the risks of 
potential side effects.
    One comment argues that neutrality has nothing to do with 
distraction and suggests that Congress intended to incorporate a 
different meaning of neutrality because it had the opportunity to 
require that the major statement be totally devoid of all potentially 
distracting information by mandating that it be in plain black-and-
white or ``tombstone'' format. This comment also notes that the 
definition of ``neutral'' from Black's Law Dictionary is ``indifferent; 
unbiased; impartial; not engaged on either side; not taking an active 
part with either of the contending sides.'' The comment states that a 
DTC ad in TV/radio format is qualitatively neutral if it neither under-
warns consumers about the major risks nor overly deters consumers from 
using a beneficial product. Thus, the comment concludes that neutral 
should relate to the content or substance of an ad and not the style or 
manner in which the content is presented.
    Furthermore, within a discussion about neutrality, the same comment 
notes that a DTC TV/radio ad that overemphasizes risks is potentially 
as misleading as one that overemphasizes benefits. Several other 
comments express similar views. One of these comments states that how 
consumers feel about prescription medications and the impressions they 
have regarding the safety of these products can affect appropriate use 
of the products. The comment also notes that the company's research 
suggests that adherence to a prescribed medication is based on three 
factors: (1) concerns about the drug (i.e., short- and long-term 
risks), (2) perceived need for the drug, and (3) concerns about drug 
cost. Another comment encourages FDA to further consider issuing 
standards to clarify what could be a subjective concept open to issues 
of interpretation and meaning. This comment encourages FDA to evaluate 
through research with target audiences whether an ad is balanced in the 
presentation of benefits and risks and whether serious risk information 
in ads is understood.
    Another comment suggests that a broad definition of ``neutral'' 
should be adopted. The comment proposes that to present information 
``neutrally'' DTC advertisements should compare the advertised 
product's risks with the expected benefits (including considerations 
relating to consumer convenience, comfort, cost, and expected 
benefits); compare the safety and efficacy of the advertised product 
with other products for the same indication (e.g., existing products 
both under patent and generic); and compare the safety and efficacy of 
the advertised product with non-pharmaceutical approaches for the same 
indication (e.g., lifestyle modifications). This comment claims that 
including this information will result in a more neutral presentation 
by giving consumers a balanced picture of the benefits and risks of the 
advertised product. A separate comment expresses its support of these 
views.
    In response to those comments, another comment says that FDA should 
not reconstruct the substantive contours of the major statement 
requirement in the guise of defining neutrality, for example, by 
requiring such concepts as comparative safety and effectiveness versus 
other pharmacologic and non-pharmacologic approaches to treatment, 
including lifestyle modifications.
    (Response 5) We agree with the general principle that it is in the 
interest of the public health that the risk information in an ad is 
presented in an engaging manner and is neither overstated nor 
understated. However, several of these comments focused in some way on 
a perceived requirement that neutrality apply to DTC TV/radio ads 
generally and were mistaken as to what information is required to be 
included in the major statement or thought that FDA might change the 
content of the major statement through this rulemaking. DTC TV/radio 
ads, like all prescription drug ads, are required to contain a fair 
balance of risk and benefit information (Sec.  202.1(e)(5)(ii)). 
However, the requirement of a clear, conspicuous, and neutral manner of 
presentation, as laid out in the statute, relates to the manner of 
presentation of the major statement and not to the manner of 
presentation of the ad as a whole. Further, FDA is not using this 
rulemaking and the requirement of a

[[Page 80968]]

``clear, conspicuous, and neutral manner'' of presentation to change 
the content of the major statement (e.g., the risk information 
provided). Thus, this rulemaking, which addresses the manner of 
presentation of the major statement, does not require that the major 
statement include benefit information in comparison to risks, 
quantitative information, or information about other pharmacologic or 
non-pharmacologic approaches for the same indications.
    FDA agrees that neutral means unbiased, and to provide more 
specific direction to firms, we establish final standards that, 
independently and collectively, help to ensure that the major statement 
is presented in a neutral, as well as clear and conspicuous manner. We 
acknowledge the research cited by the comment that describes how 
patients' beliefs about prescription drugs relate to patient propensity 
to adhere to certain prescription drugs. We agree that consumers' 
beliefs and understanding about a prescription drug informs their 
participation in important healthcare decision making, including 
decisions about whether to take the prescription drug. This rule, by 
establishing standards for the clear, conspicuous, and neutral 
presentation of the major statement in DTC TV/radio ads, helps ensure 
that consumers are better informed when they participate in healthcare 
decision making and helps ensure that DTC TV/radio ads convey a 
truthful, non-misleading net impression about the advertised drug.
    (Comment 6) One comment makes two suggestions to overcome what it 
described as biases held by manufacturers and consumers. First, it asks 
that the rule require inclusion of the statement that ``The FDA has not 
approved this ad'' to correct misleading beliefs that FDA approves all 
ads and that only drugs that are proven to be very safe can be 
advertised on TV. This comment argues that this required disclosure 
would make the major statement more neutral by disassociating the ad 
from any Government imprimatur regarding the safety of the drug or 
whether such safety is adequately described by the ad the consumer is 
seeing. Second, it asks that the rule require that the MedWatch hotline 
statement be included in DTC TV/radio ads to communicate that, overall, 
the drug being advertised is not known to be risk-free.
    (Response 6) FDA has decided that we will not require through this 
rulemaking the additional language requested by this comment addressing 
FDA non-approval of the ad and the MedWatch hotline. As explained more 
fully throughout this document, this rulemaking does not change the 
content of the major statement, but rather establishes standards that 
address the statutory requirement that the major statement be presented 
in a clear, conspicuous, and neutral manner.
    (Comment 7) Another comment states that the Distraction Study did 
not provide helpful information for FDA to consider in determining 
whether a major statement is presented in a neutral manner or provide 
evidence that a neutral presentation of the major statement is 
essential for the consumer to fully understand the risk and benefit 
information.
    (Response 7) The results of the Distraction Study are not the sole 
justification for any part of this rule; rather, the results of that 
study constitute one of many pieces of information FDA considered when 
formulating the final standards for this rule. Furthermore, to the 
extent the comment suggests that it may be unnecessary to present the 
major statement in a ``neutral'' manner, we note that Congress has 
established the requirement that the major statement be presented in a 
``clear, conspicuous, and neutral'' manner, and this rule is being 
issued consistent with that statutory requirement (21 U.S.C. 352(n)).

F. Consumer/Audience--Comments and FDA Response

    The clear, conspicuous, and neutral statutory requirement applies 
to ads for human prescription drugs that state the name of the drug and 
its conditions of use that are presented directly to consumers in TV or 
radio format (21 U.S.C. 352(n)). So, this final regulation applies to 
such ads directed toward consumers. FDA proposed in standard #1 that to 
be considered clear, conspicuous, and neutral, the major statement must 
be ``presented in language that is readily understandable by 
consumers.'' In the final rule, the language of ``by consumers'' is not 
included within this standard, for reasons explained below.
    (Comment 8) One comment suggests that FDA add the word 
``reasonable'' before ``consumer'' in proposed standard #1 to be 
consistent with FDA's draft Risk Guidance. A second comment suggests 
adding more substance to the standard by requiring the firm to take 
into account its audience either by adding ``reasonable consumer'' or 
``consumer[s] to who[m] the ad is directed'' to the end of proposed 
standard #1. Another comment, citing Sims v. GC Services, L.P., 445 
F.3d 959, 963 (7th Cir. 2006), suggests that FDA use the standard that 
the FTC adopted in relation to debt collection practices, i.e., a 
``least sophisticated consumer'' standard--someone who is ``uninformed, 
na[iuml]ve, or trusting'' but who has a ``rudimentary knowledge [about 
the subject] and who is capable of making logical deduction[s] and 
inferences.''
    (Response 8) Because this regulation applies only to DTC TV/radio 
ads, it is inherent that the audience for these ads is consumers, and 
it is unnecessary to specify a consumer audience in the codified text 
of individual standards. Accordingly, although the proposed regulatory 
text for standard #1 included the words, ``by consumers'', we do not 
include ``by consumers'' in the text of standard #1 as finalized. It is 
FDA's position that the ``consumer'' audience for a DTC TV/radio ad is 
an ordinary consumer and that the ordinary consumer acts reasonably--a 
position that is consistent with the Agency's longstanding approach in 
evaluating DTC prescription drug advertising, including the approach 
reflected in the 2009 draft Risk Guidance (Ref. 26), an approach which 
remains unchanged since the proposed rule. For the purposes of this 
rulemaking, FDA declines to adopt the ``least sophisticated consumer'' 
standard used by FTC for debt collection practices, which primarily 
focuses on specific content related to such practices. The ordinary 
consumer better aligns with FDA's interests in addressing the 
presentation of risk in DTC ads.

G. Proposed Standard #1 (Final Standard #1) (Language)--Comments and 
FDA Response

    FDA proposed in standard #1 (proposed Sec.  202.1(e)(1)(ii)(A)) 
that to be considered clear, conspicuous, and neutral, the major 
statement must be ``presented in language that is readily 
understandable by consumers.'' The concept of using language tailored 
to the consumer audience is consistent with other approaches for 
consumer disclosures (Refs. 40 and 26) (75 FR 15376 at 15378). We 
retain this concept in the final rule but, as further explained in this 
section, we modified this standard (final standard #1) to require that 
the major statement ``is presented in consumer-friendly language and 
terminology that is readily understandable.'' We have made these 
changes in response to comments we received.
    (Comment 9) Several comments suggest that the terminology of the 
major statement, as well as the language used, should be readily 
understandable by consumers. Some comments say that

[[Page 80969]]

the risk language in DTC ads is often cumbersome, confusing, and 
difficult for most consumers to understand. One comment says that most 
people will not really listen to this information, and a different 
comment says that ambiguous terms are problematic. One comment also 
notes that using scientific language in ads may mislead consumers by 
creating a false impression that the drug has been more rigorously 
tested and is thus safer than has actually been shown. Another comment 
requests that the proposed standards mimic FTC phone ad requirements, 
which require that the disclosure of risk information use the same 
language (e.g., Spanish) as the presentation of benefit or other parts 
of the ad.
    (Response 9) We generally agree with these comments--both the 
language and terminology used in the major statement should be readily 
understandable by consumers. We note that there seemed to be some 
confusion regarding the meaning of the word ``language'' in the 
proposed rule. FDA did not intend to focus on foreign language 
requirements through this rulemaking. To help clarify our intent, we 
added ``consumer-friendly'' and ``terminology'' to this standard. These 
revisions are intended to clarify that the major statement must use 
consumer-friendly language and terminology that is readily 
understandable, rather than medical or technical jargon or terms 
usually more familiar to HCPs.
    (Comment 10) One comment states that the neutrality requirement 
should mean that the risks and benefits presented in DTC ads in TV/
radio format are presented at a uniform literacy level with minimum 
technical jargon and that the information is relayed in a uniform 
typeface and uniform speed of speaking to minimize the under-
comprehension of risks and the distortion of benefits.
    Several comments request that FDA define specific criteria for 
assessing whether the major statement is ``readily understandable by 
consumers,'' such as in terms of a standard acceptable reading level. 
The comments suggest a variety of standards: (1) the Flesch-Kincaid 
Grade Level readability score; (2) the Agency for Healthcare Research 
and Quality's Effective Health Care Program guides, which are written 
at a sixth-grade literacy level; (3) the least informed person of 
limited literacy likely to view and be influenced by an ad; or (4) a 
general sixth-grade reading level.
    (Response 10) FDA agrees that final standard #1 is part of the 
evaluation of whether a major statement is presented in a neutral (as 
well as clear and conspicuous) manner. As discussed above, the 
regulation requires consumer-friendly language and terminology that is 
readily understandable. However, FDA declines to limit this standard 
through this rulemaking to language associated with a particular grade 
level of reading or similar criterion as it may be necessary to include 
certain terms (e.g., reference a disease like ``tuberculosis'') in the 
major statement that could result in a relatively high grade level 
rating. This final standard requires that the language used to provide 
the major statement's risk information is understandable to the 
ordinary consumer while providing manufacturers with flexibility in 
designing their ads.
    (Comment 11) Several comments seem to respond to our suggestion in 
the proposed rule that vague terms subject to more than one 
interpretation should be avoided (e.g., say ``more than half'' rather 
than ``some patients'') (75 FR 15376 at 15379). One comment suggests 
that safety information should be described in ways that are similar to 
the full FDA-approved product labeling. Another comment expresses 
concern about the potential for the example used in the proposed rule 
to evolve toward a general requirement to use more quantitative 
descriptors (e.g., frequency of risk, such as ``more than half'') and 
the impact it might have on comprehension of risk information. Instead 
of a general requirement to use more quantitative descriptors, the 
comment requests a more case-specific approach applied on an ad-by-ad 
basis that could be objectively tested with the target audience to 
assess whether risk information is comprehended and understood.
    Another comment recommends that FDA include clarification of 
appropriate threshold levels for quantifying risks for bothersome, 
significant, serious, or life-threatening risks attributable to the 
drug. The comment suggests that these thresholds be based on research 
in the field of risk communication to ensure that patients can 
interpret risk at the optimal level. The comment also notes that 
describing risks in quantitative terms may increase the conspicuousness 
of the risk information by drawing a consumer's attention to the 
reality of the risk described and may provide consumers with an 
evidence-based presentation that is scientifically justifiable, 
increasing the neutrality of the ad.
    (Response 11) We did not intend to propose, and have not included 
in the final rule, a general requirement that the major statement use 
quantitative descriptors. As we stated in the preamble of the proposed 
rule, ``The major statement should also avoid the use of vague terms or 
explanations that are readily subject to different interpretations,'' 
such as ``some'' (emphasis in original) (75 FR 15376 at 15379). 
Although this example involved quantitative terminology (``more than 
half''), we did not intend to require that the major statement always 
include quantitative descriptors but rather to clarify that to be 
``readily understandable,'' the major statement must avoid language or 
terminology that is so vague as to be readily subject to different 
interpretations.

H. Proposed Standard #2 (Final Standard #2) (Audio)--Comments and FDA 
Response

    FDA proposed in Sec.  202.1(e)(1)(ii)(B) that audio information in 
the major statement must be understandable in terms of the volume, 
articulation, and pacing used. This standard remains important for 
consumers to notice, attend to, and understand a drug's risk and 
benefits. We modified this standard in the final rule to clarify that 
the audio information presented during the major statement, in terms of 
the volume, articulation, and pacing used, must be at least as 
understandable as the audio information presented in the rest of the ad 
(standard #2).
    (Comment 12) We received several comments supporting this proposed 
standard but also containing suggestions for improvement. One comment 
notes that proposed standard #2 is especially important to older adults 
or to consumers who, as a result of their literacy level or of visual 
or other limitations, may rely more heavily on the audio portions of an 
ad. Several comments note that the speed at which risk information in 
the major statement is presented in broadcast ads often makes it 
difficult to understand the information. One comment states that it is 
unacceptable for risk information to be ``raced through as if being 
uttered by an auctioneer'' and suggests that the pace of risk 
information should be identical to the pace of benefit information.
    Two comments express concern that the proposed standards would 
increase the length of ads. One of these comments states that proposed 
standards #2 (audio information) and #3 (textual information) could 
impact the duration of an ad for a drug with substantial risk 
information.
    (Response 12) We agree with the comments stating that this standard 
is especially important to consumers who may rely on the audio portion 
of an ad to understand the major statement,

[[Page 80970]]

particularly older adults, as older adults watch more television (Ref. 
41) and are more likely to take prescription drugs (Refs. 42 and 43). 
As such, this standard in the final rule clarifies that the audio 
information presented during the major statement, in terms of the 
volume, articulation, and pacing used, must be at least as 
understandable as the audio information presented in the rest of the 
ad. The intention of this final standard is to ensure that the volume, 
pacing, and articulation of risk information presented in audio allow 
the information to be understood. Firms have an incentive to present 
the benefits of a drug in audio using volume, articulation, and pacing 
that ensure that those benefits are understood. Therefore, requiring 
that, in terms of these same attributes, the audio presentation of the 
major statement must be at least as understandable as the rest of the 
ad, will help ensure that the risk information in the major statement 
is similarly likely to be understood. This final standard provides a 
concrete way for firms to help meet the requirement that the major 
statement be presented in a clear, conspicuous, and neutral manner.
    We disagree with the comments that assert that the rule will 
necessarily lengthen DTC TV/radio ads. As discussed in section V.K of 
this document (see comment 21), no comments, including those from 
industry, provided specific data, information, or examples of how the 
rule would require an increase in the length of these ads. FDA 
concludes that the rule will not require DTC TV/radio ads to be longer.
    (Comment 13) One comment notes that the focus on volume, 
articulation, and pacing is important but overlooks the existing 
regulatory framework for the disclosure of risk information in DTC ads 
that results in a long disclosure of numerous risks, some of which are 
more relevant to the physician and to the patient-physician interaction 
once the decision has been made by the physician to prescribe a 
prescription drug product. This comment requests that FDA consider how 
much information is appropriate for the format.
    (Response 13) The manner of presentation of the major statement is 
the focus of this rule. Neither the proposed rule nor this final rule 
changes the content of the major statement.

I. Proposed Standard #3 (Final Standard #4) (Presentation of Text)--
Comments and FDA Response

    The third proposed standard for presenting the major statement in a 
clear, conspicuous, and neutral manner includes requirements for 
``[t]extual information [to] be placed appropriately and . . . 
presented against a contrasting background for sufficient duration and 
in a size and style of font that allows the information to be read 
easily.'' (See proposed Sec.  202.1(e)(1)(ii)(C)). We revised proposed 
standard #3 (named final standard #4 in this final rule, codified as 
revised in Sec.  202.1(e)(1)(ii)(D)) in response to comments, to 
clarify that the standard applies to the text portion of the major 
statement in TV ads and not to textual information in the TV ad 
generally. We have also removed the requirement for duration of display 
of text from this standard and address that topic in final standard #3, 
the dual modality standard. We also reorganized the remaining 
information in this standard for clarity. Like the corresponding 
standard of the proposed rule, final standard #4 is informed by 
relevant social science research as well as by the common themes seen 
in standards of other Federal agencies for ``clear and conspicuous'' 
disclosures (see Refs. 40, 44-50; 75 FR 15376 at 15377-15379).
    (Comment 14) One comment is concerned that proposed standard #3 
(final standard #4) could be interpreted to require that all major 
statements in all DTC ads in TV format include textual information. The 
comment recommends that FDA clarify the proposed standard for the 
manner of presentation of text in the major statement by inserting ``if 
included'' after ``[t]extual information.'' If information from the 
major statement is presented visually in text, the comment also 
questions how it should be presented with other information, such as 
``Available by prescription'' or ``See our ad in. . . .''
    (Response 14) Proposed standard #3 (final standard #4) addressed 
how to present textual information as part of the major statement, 
without requiring that any textual information be included. However, in 
this final rule, we require a dual modality presentation of the major 
statement for ads in TV format, through a separate standard. See 
section V.K of this document and Sec.  202.1(e)(1)(ii)(C). We therefore 
decline to add the suggested phrase, ``if included.'' We agree that 
this final standard #4 does not alone create an obligation to present 
the major statement using text, but we consider it applicable to any 
text used to present the major statement. We also revised language to 
clarify that this standard applies only to the text portion of the 
major statement in TV ads and not to other text. (Regarding the 
presentation of other information, see also section V.J of this 
document discussing final standard #5 (proposed standard #4) and 
addressing other audio or visual elements during the presentation of 
the major statement.)
    (Comment 15) One comment says that the standard should take into 
account that many patients seeing broadcast ads, such as older adults 
and those with diseases that affect vision, may need larger letters or 
other accommodations. Two comments state that text placed in the lower 
portion of the TV screen is so small and rapidly displayed as to make 
information illegible. A few other comments request that FDA require 
firms to present risks in large, clear text, while another comment 
quantifies the preferred size of the text to be at least as large as 7 
percent of the screen.
    (Response 15) We agree that text used in presenting the major 
statement, including the font used, should allow the information to be 
read easily. We disagree that it is necessary to dictate a specific 
font size or other similar criterion. After considering comments, we 
conclude that this level of detail is unnecessary because there is more 
than one way to present the textual information that will allow the 
text to be read easily. Different presentational elements may interact 
and must be considered together, with more than one combination 
allowing for the textual information to be read easily. For example, 
increasing the amount of contrast between the font and the background 
may improve readability. And, even at a smaller size, some styles of 
font are more easily read compared to others. Duration of text is 
addressed in the final rule as an aspect of dual modality. (See 
discussion in section V.K of this document.)
    (Comment 16) One comment expresses concern that proposed standard 
#3 is overly prescriptive and does not adequately take into account the 
limitations of using text in audio-visual media such as TV. The comment 
recommends that textual information be used as secondary support to 
audio disclosure for the purpose of emphasizing particular risks when 
necessary. The comment further recommends a more objective, data-
oriented approach to determine if information is understood and when 
text information might be useful to emphasize a specific point, rather 
than ensuring compliance with a specified text format.
    (Response 16) We disagree with the portion of the comment stating 
that proposed standard #3 is ``overly prescriptive.'' Like its 
counterpart in the proposed rule, this standard in the final rule does 
not dictate particular font

[[Page 80971]]

colors, sizes, placements, or backgrounds but instead requires that 
these aspects of text together result in an easily readable 
presentation. As suggested in comments, FDA intends these regulations 
to be flexible enough to allow for a variety of techniques firms may 
choose.
    We disagree with the comment's suggestion that text should be used 
to emphasize only particular risks rather than all risks contained in 
the major statement. We note that the major statement, to which the 
standards in this rule apply, is a selected presentation of the major 
side effects and contraindications of the drug and not a listing of 
every risk. In this final rule, we require a dual modality presentation 
(audio and text) of the major statement for ads in TV format, for 
reasons explained in section V.K of this document.
    (Comment 17) One comment states that the proposed language about 
textual information being placed appropriately and being presented 
against a contrasting background is not consistent with the draft Risk 
Guidance. The comment asserts that the draft guidance recommends that 
risk information have a ``comparable background.'' The comment also 
requests alignment with the draft Risk Guidance or clarification 
regarding why there is a difference in opinion between the draft 
guidance and the proposed rule for presenting risk information in TV/
radio ads versus through other media.
    (Response 17) We conclude that the final rule's requirement (that 
placement on the screen and contrast with the background, as well as 
size and style of font, enable the text portion of the major statement 
to be read easily) provides better assurance that the manner of the 
presentation is clear, conspicuous, and neutral than the comment's 
proposed requirement of a ``comparable background.'' Furthermore, 
contrary to the comment, we believe these aspects of the standard are 
consistent with the draft Risk Guidance, which was cited in the 
proposed rule as describing factors and supportive research consistent 
with the proposed rule's standards. Specifically, with respect to the 
recommendations for non-print promotion such as TV ads and video, the 
draft Risk Guidance discusses the comparable presentation of risk and 
benefit information, not ``comparable background'' (Ref. 26, p. 15, 
line 528). In fact, in its specific discussion of visual elements in 
non-print promotions, the draft guidance also recommends that risk 
disclosures presented in SUPERs contrast with background visuals (Ref. 
26, p. 20, line 676).
    With regard to the comment's question about distinctions in 
presentation based on the medium used for the promotional 
communication, we note that the draft Risk Guidance addresses 
communications in the whole range of media; whereas, this rule is 
specific to DTC TV/radio ads. Characteristics of effective 
communication, including how consumers receive and understand 
information, can be impacted by different factors for each type of 
media, as reflected in the draft Risk Guidance recommendations and the 
research that guidance cites, as well as in the final standards 
established by this rule.

J. Proposed Standard #4 (Final Standard #5) (Elements That Interfere)--
Comments and FDA Response

    FDA proposed in Sec.  202.1(e)(1)(ii)(D) that for a major statement 
to be presented in a clear, conspicuous, and neutral manner, the major 
statement must not include distracting representations (including 
statements, text, images, or sounds or any combination thereof) that 
detract from the communication of the major statement.
    As described in section III.B of this document, in proposing this 
standard, FDA noted that the presence of distracting elements during 
the disclosure was one of several common themes addressed by standards 
of other Federal agencies to ensure that disclosures were ``clear and 
conspicuous'' (75 FR 15376 at 15378). FDA also noted that this standard 
(and the other proposed standards) was consistent with the factors 
described and discussed in the draft Risk Guidance (75 FR 15376 at 
15379). The standard we finalize in this rule is generally consistent 
with these approaches. We have modified this standard slightly from the 
proposed rule as a result of the comments received (and to help ensure 
effective communication).
    In this final rule, we revised proposed standard #4, now final 
standard #5 (codified as revised in Sec.  202.1(e)(1)(ii)(E)), to 
clarify that the standard is intended to preclude the use of audio or 
visual elements during the presentation of the major statement that are 
likely to interfere with comprehension of the major statement, but the 
standard does not address elements during other portions of the ad. 
Audio or visual elements may include, for example, music or other 
sounds, statements, text, and images. The standard does not 
categorically prohibit particular types of elements during the major 
statement but will be applied by considering the facts and 
circumstances presented by specific ads.
    (Comment 18) Several comments support limiting distractions during 
the presentation of the major statement. One comment states that 
presenting the major statement without distraction is the key to 
improving audience understanding. Another comment says that distracting 
images or sounds can seriously undermine the clarity and 
conspicuousness of the presentation of risk information. One comment 
goes further and states that the major statement cannot be allowed to 
compete with distracting text, images, or sounds because it disrupts 
comprehension.\6\
---------------------------------------------------------------------------

    \6\ The comment provided reference to Sorqvist, P., et al., 
``Individual Differences in Susceptibility to the Effects of Speech 
on Reading Comprehension,'' Applied Cognitive Psychology 24: 67-76, 
2010, which concluded that irrelevant speech presented in audio 
disrupted reading comprehension.
---------------------------------------------------------------------------

    Several comments say that implementing proposed standard #4 is 
particularly important because the visual depiction of benefits 
distracts from any simultaneous verbal presentation of risks, 
especially when the risk information is listed in a monotone or 
reassuring tone of voice. One comment argues that allowing positive 
scenes to be shown while presenting risk information has an adverse 
effect on a consumer's perception of the drug's risks. The comment 
suggests that FDA require a more restrictive standard limiting drug 
manufacturers from inserting the ads in an overly positive environment 
or cheery setting and instead require that the text be displayed 
simultaneously with visual scenes that reinforce the risk.
    Other comments express reservations about proposed standard #4. One 
comment states that proposed standard #4 could be misinterpreted to 
suggest that all representations are ``distracting'' and detract from 
communication of the major statement. The comment suggests that FDA 
revise this standard to clarify that it does not intend to prohibit all 
``representations,'' including text, images, or sounds, during 
communication of the major statement. The comment suggests adding 
``certain'' before ``statements'' and adding ``significantly'' before 
``detract.''
    One comment states that it does not generally oppose the proposed 
standard but seeks clarification. In general, the comment interprets 
the proposed standard as intending to require ``neutral'' imagery. The 
comment opines that the concept of image neutrality is vaguely defined 
and subjective,

[[Page 80972]]

requiring further definition in a final standard to avoid the risk it 
could be interpreted in an unnecessarily restrictive manner that would 
make DTC advertising impractical for pharmaceutical firms. More 
specifically, the comment understands the proposed standard to be 
intended to limit visuals that may be distracting during the major 
statement and interprets this to include specifically the types of 
positive images tested in the Distraction Study; however, it concludes 
that the study did not support the position that such images would 
impede the understanding of the safety information presented during the 
major statement. The comment also says that a restriction on positive 
imagery during the major statement could lead to a sterile ``public 
service'' style presentation of the messaging and limit its efficacy. 
The comment says that patient retention of messaging and motivation to 
learn more could be decreased because, the comment asserts, such 
messages would be less engaging and be ignored. The comment also says 
it is unclear to what degree ``positive'' imagery before and after the 
major statement would be allowable.
    Another comment similarly expresses concern that proposed standard 
#4 could require firms to begin presenting risk information in a very 
bland manner that would be inconsistent with the overall flow and tone 
of an ad, such that viewers may become disengaged with the ad when risk 
information is being communicated. The comment encourages FDA to study 
the impact of removing creative elements employed during communication 
of risk information and how it affects comprehension. This comment 
opposes including proposed standard #4 because, the comment opines, it 
is too subjective and likely inadequate as a surrogate for whether the 
target audience understands the risks communicated. The comment 
expresses concern that FDA would apply an overly prescriptive approach 
to evaluating proposed standard #4 and suggests instead an objective, 
science-based approach to evaluating audience understanding and 
comprehension of risk information.
    (Response 18) We agree with comments that support the proposal to 
limit distractions during presentation of the major statement. Final 
standard #5 requires that during the presentation of the major 
statement, the ad does not include audio or visual elements (music, 
sounds, text, images, etc.) that, alone or in combination, are likely 
to interfere with comprehension of the major statement of risk 
information.
    Several of the comments suggest a desire for clarification of the 
focus or scope of proposed standard #4 (final standard #5). Some are 
concerned that this standard precludes any elements during the 
presentation of the major statement at all, while others appear to 
equate this standard narrowly with the specific topics of study in the 
Distraction Study or the concept of ``neutral'' alone--none of which 
aligns with FDA's intention. In response, in the final rule, we revised 
the wording to emphasize that in order to be presented in a clear, 
conspicuous, and neutral manner, during the presentation of the major 
statement, the ad must not include audio or visual elements that, alone 
or in combination, are likely to interfere with comprehension of the 
major statement. We conclude that the revised wording of this provision 
better captures the standard for determining whether an element or a 
combination of elements distracts from the mandatory presentation of 
the major statement. The changes to the wording of final standard #5 
also clarify that this requirement applies during the limited part of 
the ad that presents the major statement, not to other portions of the 
ad. This standard independently contributes to achieving a clear, 
conspicuous, and neutral manner of presentation of the major statement, 
adding to the effect of other standards in this rule.
    We do not conclude that all audio or visual elements are likely to 
interfere with comprehension of the major statement. In fact, as 
addressed in section V.K of this document, in the final rule, by 
requiring dual modality--the concurrent use of both text (a visual 
element) and audio to present the major statement in ads in TV format--
we acknowledge that multiple elements can actually be used to reinforce 
risk information.
    This standard does not categorically prohibit use of other creative 
elements during the major statement, nor does it prohibit narrower 
categories of such elements (e.g., it does not bar music, sound 
effects, or drawings). The standard does not even categorically 
prohibit any subtypes of elements (e.g., it does not bar upbeat music 
or amusing drawings). Notably, the standard does not categorically 
prohibit visual depictions of benefits or positive imagery during 
presentation of the major statement in TV ads.
    It is not our intent that the major statement be presented in a 
bland manner such that the audience becomes disengaged during this part 
of the ad, nor do we intend to require a ``tombstone'' presentation of 
the major statement. Rather, final standard #5 is a common-sense 
measure that adds to the others to help ensure that consumers notice, 
attend to, and understand the major statement by prohibiting the 
simultaneous presentation of other audio or visual elements, alone or 
in combination, that are likely to interfere with comprehension of the 
major statement. This requirement applies only during the limited 
portion of the ad that presents the major statement and places no 
restrictions on any other part of the ad.
    (Comment 19) Several comments discuss what effect the results of 
the Distraction Study should have on FDA policy regarding proposed 
standard #4 (final standard #5). One comment argues that design flaws 
resulted in the failure of the Distraction Study to detect any 
significant effects upon risk comprehension resulting from various 
forms of distraction; therefore, the results must be disregarded. 
Another comment states that the Distraction Study did not appear to 
provide an adequate factual or rational basis upon which FDA can rely 
to augment FDA's authority with respect to final standard #5 and the 
entire rule. One comment states that certain design characteristics of 
and results from the Distraction Study raise significant questions 
about its utility to support regulatory decision making. Another 
comment states that after reviewing the results of the Distraction 
Study, any additional restrictions imposed on the clear, conspicuous, 
and neutral standard would only ``muddy the waters'' and that a broad 
requirement, with as little nuance as possible, would enable the Agency 
to determine, unhindered, that a particular ad committed a violation of 
the clear, conspicuous, and neutral requirement. One comment says that 
in light of the results of the Distraction Study, it seems that the 
only way to present the risk information is to require a standard 
format for conveying risks. Experts could then continuously evaluate 
the standard format and determine whether it was the most effective 
method to convey the risk information.
    (Response 19) Final standard #5 rests on a well-established 
principle that presenting more than one element during the same period 
of time, in some cases, interferes with comprehension of information. 
This is often referred to as ``distraction.'' As manifested in numerous 
other Federal disclosure standards (see 75 FR 15376 at 15377), in order 
to support the effective presentation of required disclosures, it is 
important to avoid distractions.
    Addressing this concern is especially important in the ads in TV/
radio format

[[Page 80973]]

that are subject to this rule because these ads are fleeting--appearing 
for a brief interval in the midst of other content--and within each 
ad's overall running time, consumers typically do not control how much 
time they have to absorb the information from the major statement. For 
example, the average length of ads in TV format is between 30 and 60 
seconds overall.\7\ In prescription drug ads, the presentation of the 
major statement occupies only a part of the ad, so in a 30- or 60-
second ad, consumers are not given much time to notice and understand 
that important information. If, during the presentation of the major 
statement, the consumer's attention is instead focused on other 
elements of the ad, the major statement may be relayed without being 
understood.
---------------------------------------------------------------------------

    \7\ A 5-year study by DRMetrix included data from 2015 to 2018 
and captured a total of 50 million DTC TV ad presentations. The 
study evaluated the frequency with which different lengths of TV ads 
were run. Ads of 30 seconds in length were run the most. See ``5 x 5 
Industry Study,'' DRMetrix, 2019, available at https://www.drmetrix.com/public/5_x_5_Industry_Study_Oct_2019.pdf.
---------------------------------------------------------------------------

    The possibility of distraction interfering with comprehension is 
apparent from ordinary experience, and it is also amply supported by 
social science research. For example, visual and auditory elements that 
have been shown to detract from or interfere with the communication of 
information and viewer comprehension include noise, loud music, and 
rapid scene changes (Refs. 34, 35, 38, 39, 51-53). The reasonable 
approach embodied by final standard #5 is to assess, case-by-case, the 
particulars of a specific ad to determine whether, during the 
presentation of the major statement, it includes audio or visual 
elements that, alone or in combination, are likely to interfere with 
comprehension of the major statement.
    We rely on the existing substantial body of literature regarding 
distraction as the basis for final standard #5, not FDA's Distraction 
Study, contrary to the implication of some comments. As previously 
addressed (see section V.C of this document), FDA's Distraction Study 
was not an investigation of all elements or factors that can contribute 
to distraction. The Distraction Study was designed only to examine the 
effects of three particular, pre-defined factors: (1) the presence or 
absence of SUPERs that concurrently presented verbatim, key words and 
phrases from the audio presentation of risk; (2) variations in the 
positive (affective) tone of visual images; and (3) visual information 
that was either inconsistent or consistent with the audio risk 
information. With regard to factor 2, this research investigated a 
hypothesis that the visual depiction of positively toned imagery during 
the simultaneous audio presentation of risk information would interfere 
with comprehension of the risk information. Although study participants 
in the strongly positive tone conditions showed lower risk 
comprehension than participants in the mildly positive tone conditions, 
this difference was not statistically significant. As a result, the 
Distraction Study did not find support for the hypothesis that the 
visual depiction of positively toned imagery interferes with the 
comprehension of risk information in the major statement. Therefore, 
conclusions about the effect of positively toned imagery on risk 
comprehension cannot be drawn from this study.
    Nonetheless, FDA's Distraction Study did not call into question the 
substantial body of literature on different and more obvious types of 
distractions (e.g., noise, loud music, rapid scene changes); this study 
did not include and was not designed to test these well-known types of 
interferences. Thus, we rely on the existing substantial body of 
literature on this topic to support standard #5 in the final rule.
    We also disagree with the comment that suggests FDA might use the 
Distraction Study to ``augment'' its authority. Congress passed a law 
requiring that the major statement relating to side effects and 
contraindications in DTC TV/radio ads be presented in a ``clear, 
conspicuous, and neutral'' manner, and Congress directed FDA to issue 
standards for determining whether a major statement is presented in 
this manner. Final standard #5 (as well as the other final standards in 
this regulation) is consistent with this grant of statutory authority.

K. Dual Modality (Final Standard #3)--Comments and FDA Response

    In the proposed rule, FDA solicited public comment on whether to 
require that the major statement in ads in TV format be included in 
both the audio and visual parts of the presentation (dual modality) (75 
FR 15376 at 15380). We referenced the FTC standard for determining 
whether an affirmative disclosure in a television commercial is clear 
and conspicuous, 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 (75 FR 15376 at 15377, 
15380). In addition, we referenced research specifically conducted on 
the subject of dual modality in advertising that supported the use of 
simultaneous presentations of key words or full sentences in text with 
the corresponding key words or full sentences in audio to aid in 
processing (75 FR 15376 at 15383), as well as a broader body of 
research that supports the use of dual modality in a wide variety of 
situations (75 FR 15376 at 15383-15384).\8\ We also reopened the docket 
in 2012 to include the report of the Distraction Study that 
investigated dual modality presentation of the major statement in TV 
ads (among other things) and we requested comments on the results of 
that study as those results related to the proposed standards. As 
summarized in the document reopening the comment period--and further 
detailed in the study report in the docket--the study indicated that 
presenting the same risk information at the same time in text and in 
audio improves consumer understanding of the risk information (see 77 
FR 4273-74; Ref. 27). Thus, the results of FDA's Distraction Study 
regarding the effects of dual modality on comprehension of risk 
information were in line with the studies described in the 2010 
proposed rule. Not only did the Distraction Study find that presenting 
the same risk information at the same time in text and in audio 
improved risk comprehension, but it also found that presenting risk 
information in dual modality was not associated with any reduction in 
comprehension of benefits (Ref. 27). Subsequent research (Refs. 53-56) 
corroborates the evidence--originally discussed in the proposed rule 
and again in the Distraction Study report that was made available for 
public comment--that presenting information in both audio and visual 
(dual modality) improves comprehension of the information provided. The 
comments we received helped inform our decision to require dual 
modality in this final rule, supported by the Distraction Study 
research and subsequent research and literature.
---------------------------------------------------------------------------

    \8\ For additional corroboration, also see Murray, N.M., L.A. 
Manrai, and A.K. Manrai, ``Public Policy Relating to Consumer 
Comprehension of Television Commercials: A Review and Some Empirical 
Results,'' Journal of Consumer Policy, 16(2):145-170, 1993; Tindall-
Ford, S., P. Chandler, and J. Sweller, ``When Two Sensory Modes Are 
Better Than One,'' Journal of Experimental Psychology: Applied, 
(3):257-287, 1997.
---------------------------------------------------------------------------

    The majority of comments on this topic support dual modality, while 
a few comments opposed it.
    (Comment 20) Overall, the comments addressing dual modality favor 
the implementation of this standard. Comments note that dual modality 
will

[[Page 80974]]

help improve consumer understanding of the risk information and help 
make a lasting impression on consumers. Comments also noted that dual 
modality would account for consumers with different learning styles and 
pointed out that research supports dual modality. Additionally, 
comments noted that FTC has a similar standard and that including the 
dual modality standard would provide firms with direction on how to 
properly adhere to the ``clear, conspicuous, and neutral'' 
requirements. One comment gives certain critiques of the Distraction 
Study's methodology but ultimately supports a dual modality 
requirement.
    Comments that oppose dual modality assert that it is unnecessary 
and could distract consumers or have potentially negative consequences. 
One of these comments states that presenting complex clinical risk 
information simultaneously in both the audio and text could prevent 
consumers from effectively receiving this crucial information from 
either mode of communication. This comment says that viewers who focus 
on the audio component might assume that the text qualifies the audio 
message, leaving them to question the veracity of whatever portion of 
the major statement they processed and understood.
    One comment says that even though the Distraction Study suggests 
that in some contexts it may be possible to improve comprehension of 
benefit and risk information through a dual modality requirement, there 
are significant questions regarding the interpretability of that data. 
Consequently, the comment claims that the Distraction Study was not 
robust enough to support imposing a dual modality requirement in FDA's 
regulation. The comment argues that although the difference in risk 
comprehension between the no SUPERs cohort and the combined large and 
small SUPERs cohorts in the Distraction Study appears to be 
statistically significant, there is no indication that it is 
significant from a clinical or regulatory point of view. The comment 
states that even if FDA's study showed that consumers had better risk 
comprehension when SUPERs were used, it does not follow that ads that 
do not use SUPERs are: (1) false, misleading, or otherwise lacking in 
fair balance or (2) not clear, conspicuous, or neutral. The comment 
argues that ads both with and without SUPERs could be legally 
acceptable. Therefore, according to the comment, the Distraction Study 
may provide useful information regarding optimal advertising practices, 
but it does not provide information that is relevant from a regulatory 
perspective.
    The comment also states that the Distraction Study does not 
foreclose the possibility that other advertising techniques, either 
alone or in combination, may be as effective or even more effective 
than a dual modality requirement in optimizing comprehension of risks 
and benefits and rendering the major statement ``clear, conspicuous, 
and neutral.'' The comment states that advertisers should have 
regulatory flexibility in designing DTC TV ads in a manner that 
complies with applicable requirements to communicate risks, without FDA 
imposing a dual modality requirement.
    One comment opposes dual modality, arguing that it does not improve 
consumer recall or understanding of important risk information in DTC 
ads. The comment describes research that the submitting firm undertook 
in 2005, the results of which suggest that recall of risk and benefit 
information does not vary in consistent or systematic ways according to 
ad risk presentation or execution, including when dual modality is used 
to present major risk terms. The comment also states that the 
limitations of this study may have affected observed results. The same 
firm subsequently submitted the results of additional research it 
undertook several years later, described further in the response to 
this comment, which do support a dual modality requirement.
    (Response 20) We have included a dual modality requirement in this 
final rule (Sec.  202.1(e)(1)(ii)(C)) after consideration of comments 
we received, as well as research and literature supporting the positive 
impacts of dual modality on risk comprehension and recall that existed 
at the time of the proposed rule. Notably, as detailed further in 
section V.K of this document, subsequent research corroborates these 
earlier findings on the positive impact of dual modality on recall and 
comprehension of risk. Under this standard, for the major statement of 
an ad presented in TV format to be presented in a clear, conspicuous, 
and neutral manner, it must be presented concurrently using both audio 
and text (dual modality). To achieve dual modality, the regulation 
establishes further specific standards for the display of text. First, 
either the text displays the verbatim key terms or phrases from the 
corresponding audio, or the text displays the verbatim complete 
transcript of the corresponding audio. Second, the text must be 
displayed for a sufficient duration to allow it to be read easily. 
Under the final regulation, for purposes of this standard, duration of 
the text display is sufficient if it begins at the same time and ends 
at approximately the same time as the corresponding audio. These 
duration and display characteristics are supported by the research 
studies that evaluated concurrent text and audio presentations (dual 
modality), discussed in the proposed rule and in section V.C of this 
document. Moreover, as discussed in section V.K of this document, other 
research subsequently corroborated these research findings regarding 
the positive impact of dual modality on consumer recall and 
comprehension.
    We do not agree with the comment suggesting that dual modality 
could prevent consumers from effectively receiving risk information. No 
references were provided to support this assertion. To the contrary, as 
discussed in the preamble of the proposed rule (75 FR 15376 at 15383-
15384), research shows that using audio and visual presentations to 
present the same information at the same time increases comprehension 
compared to using only one mode (See also Refs. 57 and 58). Research 
demonstrates improved recall when reinforcing SUPERs are used, and 
suggests that a dual mode of presenting information results in greater 
recall and comprehension in a wide variety of situations (Refs. 53, 59, 
and 60-64). The positive impact of dual modality on recall and 
comprehension has been further demonstrated through subsequent research 
(Refs. 54-56).
    FDA's Distraction Study examined, in part, how an ad's SUPERs might 
influence understanding of the risk information in the audio portion of 
the ad. As summarized in the Federal Register document reopening the 
docket to solicit comments on the results of this study as related to 
the proposed standards (77 FR 4273-74) and further detailed in the 
study report in the docket (Ref. 27), we found that presenting the same 
risk information at the same time in text and in audio improves 
consumers' understanding of that risk information compared to audio 
alone. This finding is statistically significant and consistent with 
prior research. The Distraction Study also found that there was no 
tradeoff to the presentation of risk using dual modality in regard to 
comprehension of benefit; the increase in risk comprehension was not 
associated with any reduction in benefit comprehension (Ref. 27).
    As noted previously, research results submitted by a firm had 
similar findings about use of dual modality. The firm undertook 
research to determine how dual modality might affect consumers' recall 
and comprehension of

[[Page 80975]]

information in the major statement of prescription drug TV ads. The 
firm's research results demonstrated that dual modality increased risk 
recall and understanding of risks. The results also demonstrated that 
dual modality did not decrease consumer recall and understanding of 
product benefits. Whether the full text of the risk statement or 
keywords were presented visually did not affect recall and 
comprehension of risk information. This submitted research corroborates 
other research in the record.
    (Comment 21) One comment asserts that the proposed rule was unclear 
regarding ``what specific information from the major statement should 
be presented visually or how that visual information should be 
presented with other information, such as `Available by prescription' 
or `See our ad in Health magazine.' '' The same comment questions 
whether FDA would require ``a simultaneous, verbatim presentation'' of 
the major statement in the audio and video or only require the firm to 
use each mode to present the major statement at some point in the ad. 
It further asserts that regardless of whether dual modality requires 
simultaneous presentation of the major statement in both audio and 
text, a visual presentation of the major statement would need to appear 
on screen for a significant portion of many ads to allow consumers of 
all abilities sufficient time to read and absorb the risk information, 
which in turn might overemphasize risk information and thus result in 
the non-neutral presentation of that risk information. That comment 
also suggests that to meet a dual modality requirement, TV ads would 
necessarily grow in length to accommodate required additional text. 
However, another comment says that fulfilling a dual modality 
requirement would not require more ad time, and in fact, requiring 
audio and visual presentation of the major statement to occur at the 
same time might even reduce ad length. A third comment expresses the 
view that, to improve consumer risk awareness, the regulation should 
require that the major statement be presented in dual modality, using 
text that is either identical to the audio track or an abbreviated, 
easily processed bullet point type of text, using only words that occur 
in the audio track.
    (Response 21) To reinforce the presented risk information and 
consequently help improve its comprehension, the final rule requires 
the concurrent presentation of the major statement in the audio and in 
text. This is consistent with the proposed rule, which reflected the 
expectation that where text was used, it would appear ``concurrently 
with any directly related audio information'' (75 FR 15376 at 15379) as 
well as with the research cited in the proposed rule (75 FR 15376 at 
15383). This is also consistent with the FTC standard, cited in the 
proposed rule, for determining whether an affirmative disclosure in a 
television commercial is clear and conspicuous, 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. 65) (75 FR 15376 at 15377 and 15380). Further, the final rule 
provides additional clarity on how to achieve a dual modality 
presentation of the major statement regarding what text must appear, 
when the text must appear in relation to the audio, and for what 
duration--consistent with research cited in the proposed rule (75 FR 
15376 at 15383) and the approach used in the Distraction Study, the 
report of which was placed in the docket and the comment period 
reopened expressly to solicit comment on the results of that study in 
relation to the proposed standards (77 FR 4273-74; Ref. 27). The 
provisions in the final rule collectively provide considerable 
flexibility to firms and do not necessitate that the textual 
presentation of the major statement remain on screen throughout the ad.
    We agree with the comment noting that the text used to achieve dual 
modality should present words that the corresponding audio uses, rather 
than synonyms, and also agree that dual modality can be achieved using 
text in an abbreviated form. This is consistent with the approaches 
used in research that was cited in the proposed rule and that supported 
dual modality (75 FR 15376 at 15383), as well as the approach used in 
the Distraction Study (Ref. 27). Accordingly, the final rule specifies 
that dual modality can be achieved either by displaying the verbatim 
key words or phrases from the corresponding audio or by displaying the 
verbatim complete transcript of the corresponding audio. This provides 
firms flexibility to choose from various presentation options. For 
example, if the audio states, ``The most common side effects of DRUGX 
are dry mouth, headache, and heartburn,'' instead of presenting a 
complete verbatim transcript of that statement, the accompanying text 
could present bullets stating `` dry mouth  headache 
 heartburn.''
    The final rule also addresses the duration of text display. Like 
proposed standard #3 (which alone would not have required text, but 
addressed how to present text if it were used in addition to the 
already-required audio to present the major statement), the final rule 
requires that text used to present the major statement be displayed for 
a duration that allows it to be read easily. Discussion of proposed 
standard #3 also indicated our intention to require that visually-
presented text information from the major statement appear 
``concurrently with any directly related audio information'' (75 FR 
15376 at 15379). These elements of proposed standard #3 regarding the 
display of text are now picked up as part of the dual modality 
requirement (final standard #3). Final standard #3 clarifies their 
relationship to each other and to the audio presentation requirements 
of the rule, stating that the duration of display of text is sufficient 
if it starts at the same time and ends at approximately the same time 
as the corresponding audio. This approach is similar to that required 
for the presentation of closed captioning under Federal Communication 
Commission regulations. See 47 CFR 79.1(j)(2)(ii). In turn, the pace of 
the audio component of the major statement is determined by the 
requirement that the audio information be at least as understandable as 
the audio information presented in the rest of the ad--something that 
the firm chooses. (See final standard #2 (Sec.  202.1(e)(1)(ii)(B)) and 
section V.H of this document.) With this flexibility, we believe the 
presentation of risk information will not be overemphasized. None of 
the standards of the final rule that impact duration of text display, 
including the dual modality standard, either separately or together, 
require that the textual presentation of the major statement remain on 
screen throughout the ad or generally require increasing the length of 
ads in order to present the major statement. At the same time, we think 
the methods of achieving dual modality described by the rule will 
contribute to presenting the major statement in a clear, conspicuous, 
and neutral manner.

L. First Amendment Freedom of Speech--Comments and FDA Response

    Two comments question whether the proposed rule is consistent with 
First Amendment protections for freedom of speech. One addresses the 
major statement's requirement to disclose side effects generally; the 
other focuses on the proposal for presenting the major statement using 
dual modality.
    (Comment 22) One comment asserts that the overall requirement for 
the major statement to disclose side effects is unconstitutional under 
the Supreme Court's decision in Central Hudson Gas & Elec. Corp. v. 
Pub. Serv. Comm'n, 447 U.S. 557 (1980), regarding commercial

[[Page 80976]]

speech restrictions, but the comment does not address any specific 
elements of the proposed manner of presentation that are the subject of 
this rulemaking. This comment asserts that, for the Government to 
restrict advertising, among other things, the advertising must be 
misleading, and the comment states without elaboration that ``lack of 
disclosure or lack of clarity'' of side effects does not make 
advertising misleading. The comment also asserts that the Government 
has no substantial interest in mandating disclosure of risk information 
in DTC ads in TV/radio format and, consequently, that no requirements 
for a major statement in a DTC ad could satisfy the First Amendment. 
The comment states that the Government interest implicated by requiring 
disclosure of side effects in DTC prescription drug advertising is one 
intended to protect consumer safety but that this interest ``cannot be 
proven as substantial'' because it is already addressed by the 
requirement to obtain a prescription to access a prescription drug. The 
comment further suggests that the information is unnecessary in ads 
because all prescription orders explain drug side effects.
    Another comment raises concerns that a dual modality requirement 
would violate the First Amendment. The comment suggests that the 
proposed dual modality requirement is subject to First Amendment 
analysis under Central Hudson and under Thompson v. Western States 
Medical Center, 535 U.S. 357 (2002), and also suggests that ``a 
regulatory scheme that formats the style and content of advertising in 
advance of its presentation to the public'' might impose an unlawful 
prior restraint on advertising. In addition, the comment asserts that 
to hold a firm liable for failing to use dual modality, FDA would have 
to prove that absent dual modality, the ad would be false or misleading 
to the consumer, noting that a consumer cannot obtain a prescription 
for an advertised drug without consulting a physician. The comment 
suggests that, unless FDA can establish in advance that all ads that 
lack dual modality would be false or misleading, the dual modality 
requirement is not constitutional.
    (Response 22) We disagree that the major statement requirement as a 
whole, the dual modality requirement in particular, or any other aspect 
of this rule's standards for presenting the major statement in a clear, 
conspicuous, and neutral manner violates the First Amendment.
    As the Supreme Court has explained, Government mandates for 
``health and safety warnings'' have been ``long considered 
permissible,'' and these warnings as well as ``purely factual and 
uncontroversial disclosures about commercial products'' are legal under 
the First Amendment (Nat'l Inst. of Family and Life Advocates v. 
Becerra, 138 S. Ct. 2361, 2376 (2018)). The presentation of the major 
statement addressed in this rule, as well as the underlying requirement 
to provide the important side effects and contraindications of the 
drug, fall squarely within these categories.
    Specifically, the major statement is quintessential health and 
safety warning information, reflecting the contraindications and side 
effects of a prescription drug as described in the prescription drug's 
approved labeling. The content of the major statement is not changed by 
this rulemaking. As explained in section III of this document, there is 
a long history of requirements to provide health and safety warnings 
about a prescription drug's risks, including in its advertising, and to 
ensure that understanding of required disclosures about these products 
is not undermined by an inadequate manner of presentation of the 
information.
    More generally, the major statement is a factual disclosure about a 
commercial product to be included in its advertising. The Supreme Court 
examines factual disclosures about products and services in commercial 
speech under the analysis in Zauderer v. Office of Disciplinary 
Counsel, 471 U.S. 626 (1985). See Nat'l Inst. of Family and Life 
Advocates, 138 S. Ct. 2361, 2377-2378; Milavetz, Gallop & Milavetz, 
P.A. v. United States 559 U.S. 229, 250, 252-253 (2010). Under the 
approach articulated in Zauderer, courts have upheld required 
disclosures of factual and uncontroversial information about a product 
or service in commercial speech about that product or service. See, 
e.g., American Hosp. Ass'n, 983 F.3d 528, 540 (posting negotiated rates 
for hospital services); American Meat Inst. v. Dept. of Agric., 760 
F.3d 18 (D.C. Cir. 2014) (en banc) (country of origin labeling for 
meat); N.Y. State Restaurant Ass'n v. N.Y.C. City Bd. of Health, 556 
F.3d 114 (2d Cir. 2009) (calorie information on menus); Nat'l Elec. 
Mfrs. Ass'n, 272 F.3d 104 (labeling identifying presence of mercury in 
light bulbs). Where such disclosures are not unjustified or unduly 
burdensome, their imposition does not offend the First Amendment. See, 
e.g., Nat'l Inst. of Family and Life Advocates, 138 S. Ct. 2361, 2377-
2378; American Hosp. Ass'n, 983 F.3d 528, 541 (required publication of 
standard charges is not unduly burdensome in a way that chills 
commercial speech as it ``neither requires hospitals to endorse a 
particular viewpoint nor prevents them from adding their own message on 
the same website or even in the same file''; alleged financial burden 
of compliance with the disclosure requirement not established to be 
burden on speech); Spirit Airlines, Inc. v. United States Dep't of 
Transp., 687 F.3d 403, 414 (D.C. Cir. 2012) (requirement for airlines 
to make total price the most prominent cost figure does not 
significantly burden airlines' ability to advertise); Discount Tobacco 
City & Lottery, Inc., 674 F.3d 509, 524 (size of required tobacco 
warnings is not unduly burdensome where remaining portions of their 
packaging are available for other information).
    The provisions of this rule likewise satisfy the requirements of 
Zauderer and subsequent cases. First, the required information about 
the drug's side effects and contraindications presented in the major 
statement is factual and uncontroversial. As already noted, it is 
derived from the drug's FDA-approved labeling, which is based on data 
and information about the product submitted by the drug's sponsor and 
evaluated by FDA.
    Second, requiring that this information be presented in DTC TV/
radio ads in a clear, conspicuous, and neutral manner is justified by 
the interests described in section III of this document. Contrary to 
the implications of both comments, the substantial Government interests 
supporting these measures are not limited to preventing consumers from 
being misled or protecting consumer safety. Rather, the substantial 
Government interests underlying this rule also include helping to 
ensure consumers are better informed when they participate in 
healthcare decision making, including when no HCP is present (see 
discussion in section III.A). Communicating risk information in a 
manner that improves the likelihood that consumers notice, attend to, 
and comprehend that information is instrumental to advancing this 
purpose of including risk information in the first place. See Discount 
Tobacco City & Lottery, Inc., 674 F.3d 509, 561-564 (enhanced warnings 
on tobacco products advance the interests in promoting greater public 
understanding of the risks of those products; ``A warning that is not 
noticed, read, or understood by consumers does not serve its 
function'').
    Third, this rule is not unduly burdensome. The final rule's 
requirements for the manner of presenting the major statement--
including the requirement for dual

[[Page 80977]]

modality--do not threaten to drown out or chill the firm's other 
messages. Indeed, the firm not only remains free to present other 
messages in the ad; under this rule, it retains substantial ability to 
choose how to present the major statement.
    For example, the major statement has long been required to be 
presented in audio. This rule provides more direction on how to do so 
but leaves many implementation details up to the firm. With regard to 
this audio presentation, the final standard requires that the volume, 
articulation, and pacing make the audio presentation of the major 
statement ``at least as understandable as the audio presented in the 
rest of the advertisement'' (Sec.  202.1(e)(1)(ii)(B))--leaving it 
substantially up to the firm how it wants to use audio for all the 
content in the ad. To fulfill the dual modality requirement for ads in 
TV format, the display of text is sufficient if it begins at the same 
time and ends at approximately the same time as the corresponding audio 
and displays the verbatim key terms or phrases from the corresponding 
audio (Sec.  202.1(e)(1)(ii)(C)). Ultimately, then, this final rule, 
including dual modality, retains the firm's substantial control of the 
overall presentation and duration of the major statement and preserves 
the firm's opportunity to present the advertised drug's benefits or any 
other messages in other parts of the ad. And, as discussed in section 
V.K of this document, the use of dual modality does not decrease the 
recall or comprehension of benefit information even while it improves 
consumer comprehension and recall of the risk information, advancing 
the Government interests discussed in section III.A.1 of this document.
    While we conclude that Zauderer provides the relevant framework for 
analysis of the mandatory risk disclosure provisions of this rule and 
that its requirements are satisfied, we also conclude that this 
rulemaking is consistent with the First Amendment if analyzed under 
more exacting scrutiny, including Central Hudson, a case mentioned by 
both comments. Contrary to the implication of both comments, FDA's 
authority to regulate prescription drug advertising is not limited to 
cases in which that speech is misleading (or false). Rather, under the 
Central Hudson framework, even if commercial speech is truthful, is not 
inherently or actually misleading, and relates to lawful activity, the 
Government may impose restrictions that directly advance a 
``substantial'' Government interest and are no ``more extensive than is 
necessary to serve that interest'' (Central Hudson Gas & Elec. Corp., 
447 U.S. 557, 566).
    In cases examining limitations on commercial speech, the Supreme 
Court has endorsed ``the principle that disclosure of truthful, 
relevant information is more likely to make a positive contribution to 
decisionmaking than is concealment of such information'' (Peel v. 
Attorney Registration and Disciplinary Comm'n of Illinois, 496 U.S. 91, 
108 (1990)). As a result, the Court has favored use of disclosures over 
restrictions on speech to advance the substantial interests in 
preventing consumers from being misled and in making a positive 
contribution to informed decision making (id. at 109-110); Shapero v. 
Kentucky Bar Ass'n, 486 U.S. 466, 477-478 (1988); In re R.M.J., 455 
U.S. 191, 203 (1982); Bates v. State Bar of Arizona, 433 U.S. 350, 375 
(1977); Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer 
Council, 425 U.S. 748, 770 (1976).
    Similarly, the FD&C Act and FDA implementing regulations require 
disclosures of risk information where prescription drug ads promote the 
product's benefits to directly advance the substantial Government 
interests previously described in section III of this document. The 
requirements in this rule to ensure that important facts about the 
risks of an advertised drug are presented in a clear, conspicuous, and 
neutral manner in its DTC TV/radio ads are reasonable in proportion to 
these interests and thus present no constitutional infirmity under any 
potentially applicable First Amendment standard.
    Three of the standards for presenting the major statement address 
basic techniques for any communication targeting a broad consumer 
audience: that it uses consumer-friendly language and terminology, 
rather than technical language; that its audio be at least as 
understandable as other audio in the same ad; and that the visual 
aspects of text used to present the major statement allow that text to 
be read easily. (See Sec.  202.1(e)(1)(ii)(A), (B), and (D).) The two 
remaining standards likewise are appropriately tailored to the 
interests behind the rule and do not unreasonably burden speech. Dual 
modality has already been discussed, and as noted, research indicates 
that using this technique to present risk information improves consumer 
risk comprehension and recall--advancing the Government interest--
without decreasing the recall or comprehension of benefit information, 
thus reinforcing the reasonableness of this requirement. (See Sec.  
202.1(e)(1)(ii)(C).)
    The last standard, in Sec.  202.1(e)(1)(ii)(E), is a common-sense 
measure that adds to the others to help ensure that consumers notice, 
attend to, and understand the major statement by prohibiting the 
simultaneous presentation of other audio or visual elements, alone or 
in combination, that are likely to interfere with comprehension of the 
major statement. This requirement applies only during the limited part 
of the ad that presents the major statement, placing no restrictions on 
any other part of the ad. Even during the presentation of the major 
statement, it does not categorically prohibit other audio or visual 
elements. In sum, these measures to advance the substantial Government 
interests in communicating the major side effects and contraindications 
of a prescription drug advertised to consumers satisfy the framework 
for analysis described in Central Hudson and are consistent with the 
First Amendment.
    FDA has considered and rejects the suggestion in the comments that 
the Government interests that justify this rule are adequately advanced 
by the requirement to obtain a prescription from an HCP to access a 
prescription drug. The comments do not recognize consumers as active 
participants in their own healthcare, and do not address the Government 
interest in helping to ensure that consumers are better informed when 
they participate in healthcare decision making. This Government 
interest is not completely or sufficiently addressed by the requirement 
to obtain a prescription or visit an HCP before accessing a 
prescription drug. Both before and after contact with an HCP, consumers 
are frequently exposed to DTC TV/radio ads describing the drug's 
benefits. Requiring that such ads also convey the advertised product's 
risks better advances the substantial Government interests than 
reliance on the HCP alone. For example, for a patient already taking a 
prescribed drug, certain side effects may occur at any time, and 
presenting information about that drug's risks in DTC ads provides the 
patient with information about the side effects each time they 
encounter the ad. Providing this information helps ensure that 
consumers are better informed about side effects that they may 
experience in connection with their use of the drug. Furthermore, the 
assumption in comments that HCPs or ``prescription orders'' will 
communicate prescription drug risks to consumers does not dispute that 
consumers should be informed of those risks. Rather, it

[[Page 80978]]

appears to suggest that it is appropriate for a pharmaceutical firm to 
benefit from advertising its prescription drug's positive attributes 
directly to consumers while placing the entire burden of informing 
consumers about that advertised drug's risks on other members of the 
healthcare system. The First Amendment does not compel us to adopt that 
policy.
    One of the comments also cited Western States, in which the Court 
applied the Central Hudson test to evaluate the advertising restriction 
at issue (535 U.S. 375 at 368-77). In an analysis that broke no ``new 
ground'' (id. at 368), the Court explained that, in general, the 
Government should not restrict the communication of truthful and non-
misleading information for the sole purpose of preventing members of 
the public from making bad decisions with the information (id. at 374). 
That holding and rationale has no application to this rule, where 
formatting and presentation requirements help ensure the effective 
disclosure of information to the public.
    Finally, with regard to the mention of prior restraint in the 
context of the comment on dual modality, we disagree that this rule 
presents any constitutional infirmity under that analysis. The 
fundamental concern of the prior restraint doctrine is with Government 
censorship in advance of publication. See Southeastern Promotions, Ltd. 
v. Conrad, 420 U.S. 546, 553 (1975). Here, however, neither the dual 
modality requirement nor any other aspect of this rule requires a firm 
to seek any permission from FDA before running an ad or otherwise 
enjoins speech before it occurs, and therefore the regulation does not 
impose a prior restraint. See, e.g., Alexander v. United States, 509 
U.S. 544, 549-553 (1993).

M. Role of Healthcare Professional--Comments and FDA Response

    (Comment 23) One comment asserted that too much information in the 
major statement can make it difficult for the audience to comprehend 
the information and that the role of the prescribing HCP as a learned 
intermediary is an important consideration in determining the relevancy 
of risk information to be included in a DTC broadcast ad.
    Another comment says that because doctors are responsible for their 
patient's care and well-being, prescription drug ads should be required 
to include--``instead of a clear, conspicuous, and neutral statement of 
effects and contraindications''--a statement ``that only a patient's 
doctor can fully provide this vital information.''
    (Response 23) This rulemaking does not change the content of the 
major statement, but focuses on the manner of presenting it in DTC TV/
radio ads. Further, FDA acknowledges the role of HCPs regarding 
prescription drugs; however, as discussed in section III.A of this 
document, that role does not completely address the reasons to require 
prescription drug firms to communicate risk information about their 
products in a clear, conspicuous, and neutral manner in DTC TV/radio 
ads that communicate the benefits of such products.

N. Costs--Comments and FDA Response

    (Comment 24) One comment states that the specific dollar estimates 
to revise any ad with a life cycle extending beyond the compliance date 
of the final rule were optimistically low and questions how FDA or its 
industry sources arrived at these estimates. Furthermore, the comment 
requests that FDA revisit the cost estimates (and publish a more 
detailed analysis) to make certain that they accurately reflect the 
costs that firms will incur in bringing their existing campaigns into 
compliance. As part of addressing costs, the comment requests that FDA 
consider a longer effective date.
    (Response 24) No comments included quantified costs that firms will 
incur in bringing their existing campaigns into compliance. With regard 
to the request for an updated estimate of costs, we direct readers to 
the Regulatory Impact Analysis (Ref. 66), which evaluates the 
anticipated costs to firms for complying with this rule. In light of 
concerns regarding costs, FDA has agreed to a compliance date of 365 
days after the date of the final rule publication for all ads. (See 
section VI of this document.)

O. Enforcement--Comments and FDA Response

    (Comment 25) One comment suggests that FDA should enforce these 
standards through civil monetary penalties (CMPs) for misleading DTC 
advertising, as authorized under 21 U.S.C. 333(g)(1).
    (Response 25) Failure to follow this rule will render a drug 
misbranded under 21 U.S.C. 352(n). The Agency will have all compliance 
tools associated with its authority available to enforce these 
provisions; see generally the FD&C Act sections 301 (prohibited acts), 
302 (21 U.S.C. 332) (injunction proceedings), and 303 (penalties), 
including, as applicable, CMPs for false or misleading DTC ads 
authorized under section 303(g)(1) of the FD&C Act (21 U.S.C. 
333(g)(1)).

VI. Effective/Compliance Dates

    This rule is effective May 20, 2024. The compliance date is 
November 20, 2024.
    As described in the proposed rule, in accordance with FDAAA, the 
statutory requirement that the major statement in human prescription 
drug advertisements presented directly to consumers in television or 
radio format and stating the name of the drug and its conditions of use 
be presented in a clear, conspicuous, and neutral manner has been in 
effect since March 25, 2008 (75 FR 15376 at 15380). In the proposed 
rule, FDA proposed that the standards in the final rule would become 
effective 90 days after the publication of the final rule in the 
Federal Register.
    (Comment 26) One comment supports the 90-day proposal. Two comments 
request the earliest possible implementation of the proposed standards. 
Another comment agrees that 90 days is reasonable for DTC ads that have 
not already begun production. However, the comment suggests 180 days 
for ads that are already in production or circulation because it allows 
time for modifications if required.
    (Response 26) Based on comments, FDA agrees that it is appropriate 
to provide a longer period for implementation than originally proposed. 
We therefore make the effective date 180 days after publication. 
Affected firms are encouraged to comply as soon as possible after the 
effective date. However, we recognize that this rule could impact 
existing ads, ads in production, and distribution agreements. 
Accordingly, we now conclude that a compliance date of 365 days after 
the date of publication of the final rule is appropriate to enable 
firms to bring all ads subject to this rule into compliance without 
undue burden. One schedule of 365 days after publication of the final 
rule for compliance is clearer and easier to administer than having two 
different schedules depending on where the ad is in production or on 
other factors. While we did not receive data to support an alternative 
estimate of costs, given the complexities of distribution agreements 
and concerns raised with costs, we have also determined that a longer 
time for implementation is appropriate.

VII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional

[[Page 80979]]

Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 
801, Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4).
    Executive Orders 12866, 13563, and 14094, direct us to assess all 
benefits, costs and transfers 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). Rules are ``significant'' under Executive Order 12866, 
section 3(f)(1) (as amended by Executive Order 14094), if they ``have 
an annual effect on the economy of $200 million or more (adjusted every 
3 years by the Administrator of the Office of Information and 
Regulatory Affairs (OIRA) for changes in gross domestic product); or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, territorial, or tribal governments 
or communities.'' OIRA has determined that this final rule is not a 
significant regulatory action under Executive Order 12866, section 
3(f)(1).
    Because this rule is likely to result in an annual effect on the 
economy of $100 million or more or meets other criteria specified in 
the Congressional Review Act/Small Business Regulatory Enforcement 
Fairness Act, OIRA has determined that this rule does fall within the 
scope of 5 U.S.C. 804(2).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the estimated costs of compliance in the first year 
could exceed 1 percent of sales revenues for the smallest affected 
entities, we find that the final rule will have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
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 $177 
million, using the most current (2022) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    Under section 502(n) of the FD&C Act, as amended by section 
901(d)(3)(A) of FDAAA, Congress has mandated that the disclosure of the 
major side effects and contraindications of the advertised product 
(known as the ``major statement'') in human prescription drug ads 
presented directly to consumers in TV or radio format stating the name 
of the drug and its conditions of use 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 
accordance with this legislation, this final rule requires that the 
major statement in such ads be presented in a clear, conspicuous, and 
neutral manner and provides standards for determining whether this is 
the case.

B. Summary of Costs and Benefits

    The costs of this final rule include the cost to read and 
understand the rule, to revise a firm's standard operating procedures, 
and to revise DTC TV/radio ads during the transition period leading up 
to the compliance date. These activities and their associated costs 
will occur during the first year. We also expect there to be modest 
ongoing costs for industry to review future DTC TV/radio ads to ensure 
that these ads comply with this final rule and an ongoing opportunity 
cost related to a potential change in the relative allocation of time 
within the ad between the presentation of the major statement and the 
presentation of other content. The total present value of costs over a 
10-year time horizon ranges from $104.8 million to $331.8 million, with 
a primary estimate of $218.3 million, at a 7 percent discount rate; the 
present value ranges from $123.8 million to $393.0 million, with a 
primary estimate of $258.4 million, at a 3 percent discount rate. 
Annualized costs over a 10-year time horizon range from $14.9 million 
to $47.2 million, with a primary estimate of $31.1 million at a 7 
percent discount rate; annualized costs over a 10-year time horizon 
range from $14.5 million to $46.1 million, with a primary estimate of 
$30.3 million at a 3 percent discount rate.
    The benefits of this final rule stem from and include helping 
consumers notice, attend to, and understand the major statement in DTC 
TV/radio ads. The standards in the final rule help to ensure that DTC 
TV/radio ads convey a truthful and non-misleading net impression about 
the advertised drug and help ensure that consumers are better informed 
when they participate in healthcare decisionmaking.
    Table 1 summarizes the annualized costs and describes the benefits 
of this final rule.

                                      Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Units
                                                                                    ------------------------------------
                    Category                       Primary       Low        High                               Period                 Notes
                                                  estimate    estimate    estimate      Year      Discount     covered
                                                                                       dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year........  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
    Annualized Quantified......................  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
                                                --------------------------------------------------------------------------------------------------------
    Qualitative................................  Helping consumers notice, attend to, and understand the
                                                 major statement in DTC TV/radio ads
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year........        31.1        14.9        47.2        2020           7          10
                                                       30.3        14.5        46.1        2020           3          10
    Annualized Quantified......................  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
                                                --------------------------------------------------------------------------------------------------------
    Qualitative................................
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:

[[Page 80980]]

 
    Federal Annualized Monetized $millions/year  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
                                                --------------------------------------------------------------------------------------------------------
    From/To....................................  From:
                                                 To:
                                                --------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/year..  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
                                                --------------------------------------------------------------------------------------------------------
    From/To....................................  From:
                                                 To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None.............................................................................................................
    Small Business: Compliance costs in the first year may exceed 1 percent of revenues for the smallest affected entities..............................
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (docket number 
FDA-2009-N-0582) (Ref. 66) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We have 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.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title, 
description, and respondent description of the information collection 
provisions are shown in the following paragraphs with an estimate of 
the annual third-party disclosure 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 
each collection of information.
    Title: Prescription Drug Advertisements.
    Description: Under Sec.  202.1, FDA has established requirements 
for ads for human prescription drug and biological products and ads for 
animal prescription drugs. The regulations apply to ads including those 
published in journals, magazines, other periodicals, and newspapers and 
those broadcast through media, such as radio, TV, 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 final rule, the Agency amends these regulations. Specifically, 
under Sec.  202.1(e)(1)(ii), FDA implements section 502(n) as amended, 
which requires that in human prescription drug advertisements 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 must be presented in a 
clear, conspicuous, and neutral manner. The rule also includes 
standards for determining whether the major statement is presented in a 
clear, conspicuous, and neutral manner.
    General requirements for prescription drug ads to include a true 
statement of information in brief summary relating to side effects, 
contraindications, and effectiveness are located in the opening 
paragraph of Sec.  202.1(e), and specific provisions for prescription 
drug ads broadcast through media such as radio, TV, or telephone 
communications systems addressing inclusion of the major statement and 
adequate provision of the approved labeling are located in Sec.  
202.1(e)(1)(i). These provisions were already in effect and approved 
under OMB control number 0910-0686. The requirements of Sec.  
202.1(e)(1), including these existing requirements and new requirements 
imposed by this final rule in Sec.  202.1(e)(1)(ii)--which address only 
the manner of presentation of the major statement in certain ads while 
retaining the pre-existing content requirements--collectively mandate 
that ads disclose information to the public and thus are subject to the 
Paperwork Reduction Act of 1995.
    Description of Respondents: Respondents to the collection of 
information are manufacturers, packers, and distributors; application 
holders and their representatives with approved new drug applications 
(NDAs), abbreviated new drug applications (ANDAs), and biologics 
licensing applications (BLAs) for human prescription drugs; and those 
that market prescription drugs for human use without an approved 
application.
    Based on a recent review of data collected via FDA Form 2253 
advertisement submissions, we revised our previously estimated burden 
of this information collection. Specifically, relying on data from 
calendar year 2020 Form 2253 submissions, we increased the number of 
corresponding disclosures and recalculated the burden as an increase to 
the existing burden, using the most recent numbers for that burden 
estimate, under the approved OMB control number 0910-0686 collection 
covering the regulations under Sec.  202.1. The collections of 
information pertaining to FDA Form 2253 (``Transmittal of 
Advertisements and Promotional Labeling for Drugs and Biologics for 
Human Use,'' located on the FDA website at https://www.fda.gov/about-fda/reports-manuals-forms/forms) are approved under OMB control numbers 
0910-0001 and 0910-0338.
    FDA estimates the burden of the collections of information as 
follows:

[[Page 80981]]



        Table 2--Estimated Burden Resulting From Revising TV/Radio Ads To Comply With 21 CFR 202.1(e)(1)
----------------------------------------------------------------------------------------------------------------
                                                           Number of                         Hourly
   21 CFR 202.1--Prescription drug        Number of     disclosures per    Total annual    burden per    Total
              marketing                  respondents       respondent       disclosures    disclosure    hours
----------------------------------------------------------------------------------------------------------------
One-time activities: reading and                   57                  3             171          2.5      427.5
 understanding rule, revising company
 SOPs, modifying existing ads (if
 necessary)..........................
202.1(e)(1)(ii): Ongoing                           57              11.02             628            5      3,140
 implementation of revised
 requirements for future TV and radio
 ads.................................
                                      --------------------------------------------------------------------------
    Total............................  ..............  .................             799  ...........    3,567.5
----------------------------------------------------------------------------------------------------------------

    According to this 2020 submission data from the Center for Drug 
Evaluation and Research (CDER), we estimate 564 DTC TV ads for 
prescription drugs will be prepared by 37 firms under Sec.  
202.1(e)(1)(ii) annually. Likewise, based on data from the Center for 
Biologics Evaluation and Research (CBER), we estimate that six DTC TV 
ads will be prepared by three firms annually. Our total estimated 
number of DTC TV ads under Sec.  202.1(e)(1)(ii), then, is 570. Based 
on our experience with reviewing DTC TV ads, we believe an expenditure 
of approximately 5 hours per disclosure should be sufficient to ensure 
that the major statement in DTC TV ads is presented in a clear, 
conspicuous, and neutral manner in accordance with the requirements of 
this final rule.
    Also based on data from CDER, we estimate 56 DTC radio ads for 
prescription drugs will be prepared by 16 firms under Sec.  
202.1(e)(1)(ii) annually. Based on data from CBER, we estimate two DTC 
radio ads will be prepared by one firm annually. The total estimated 
number of DTC radio ads subject to disclosures under Sec.  
202.1(e)(1)(ii), then, is 58. Based on our experience reviewing DTC 
radio ads, we believe an expenditure of approximately 5 hours per 
disclosure should satisfy the requirements in Sec.  202.1(e)(1)(ii).
    In sum, as shown in table 2, FDA estimates that, annually, 57 
respondents will submit DTC TV or radio ads, resulting in 628 
disclosures. FDA estimates 5 hours per disclosure will satisfy the 
requirements, resulting in an estimated annual expenditure of 3,140 
hours. In addition, as noted in the table, FDA estimates that, for 
those 57 respondents, there will be a one-time burden of 427.5 hours.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

X. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the 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, we conclude that the 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.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive order and, consequently, a 
tribal summary impact statement is not required.

XII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

*1. FDA, Guidance for Industry, ``Consumer-Directed Broadcast 
Advertisements,'' August 1999, available at https://www.fda.gov/media/75406/download, accessed July 12, 2022.
*2. DeFrank, J.T., N. Berkman, L. Kahwati, et al., ``Direct-to-
Consumer Advertising of Prescription Drugs and the Patient-
Prescriber Encounter: A Systematic Review,'' Health Communication, 
35(6):739-746, 2020, doi:10.1080/10410236.2019.1584781.
3. Kornfield, R., J. Donohue, E.R. Berndt, et al., ``Promotion of 
Prescription Drugs to Consumers and Providers, 2001-2010,'' PLOS 
ONE, 8(3):e55504, 2013, doi:10.1371/journal.pone.0055504.
4. Kornfield, R., G.C. Alexander, D.M. Qato, et al., ``Trends in 
Exposure to Televised Prescription Drug Advertising, 2003-2011,'' 
American Journal of Preventive Medicine, 48(5):575-579, 2015, 
doi:10.1016/j.amepre.2014.12.001.
*5. Sullivan, H.W. and M. Campbell, ``Do Prescription Drug Ads Tell 
Consumers Enough About Benefits and Side Effects? Results from the 
Health Information National Trends Survey, Fourth Administration,'' 
Journal of Health Communication, 20(12):1391-1396, 2015, 
doi:10.1080/10810730.2015.1018635.
6. Koo, K. and R.L. Yap, ``Trends in Urological Direct-to-Consumer 
Advertising During Prime-Time Television News Programs,'' Urology 
Practice, 4(1):7-13, 2017, doi:10.1016/j.urpr.2016.03.005.
*7. U.S. Congressional Research Service, ``Direct-to-Consumer 
Advertising of Prescription Drugs,'' Report R40590, May 20, 2009. 
Available at https://crsreports.congress.gov/product/pdf/R/R40590.
8. Medical Marketing and Media, ``How DTC spending shifted in 
2020,'' March 25, 2021, available at https://www.mmm-online.com/home/channel/features/how-dtc-spending-shifted-in-2020/, accessed 
July 12, 2023.
9. Bulik, B., ``The Top 10 Ad Spenders in Big Pharma for 2020,'' 
Fierce Pharma, April 19, 2021, available at https://
www.fiercepharma.com/special-report/

[[Page 80982]]

top-10-ad-spenders-big-pharma-for-2020, accessed September 27, 2022.
*10. Applequist, J. and J.G. Ball, ``An Updated Analysis of Direct-
to-Consumer Television Advertisements for Prescription Drugs,'' 
Annals of Family Medicine, 16(3):211-216, 2018, doi:10.1370/
afm.2220.
11. PhRMA, ``PhRMA Guiding Principles: Direct to Consumer 
Advertisements About Prescription Medicines,'' 2008, revised October 
2018.
12. DiJulio, B., J. Firth, and M. Brodie, ``Kaiser Health Tracking 
Poll: October 2015,'' Kaiser Family Foundation, October 28, 2015, 
available at https://www.kff.org/health-costs/poll-finding/kaiser-health-tracking-poll-october-2015, accessed July 12, 2022.
13. Princeton Survey Research Associates International for PhRMA, 
``2017 Direct-to-Consumer Advertising Survey Results,'' July 18, 
2017, available at https://phrma.org/resource-center/Topics/Medicine-Safety/2017-Direct-to-Consumer-Advertising-Survey-Results, 
accessed July 12, 2022.
14. Lee, M., K.W. King, and L.N. Reid, ``Factors Influencing 
Consumers' Attitudinal and Behavioral Responses to Direct-To-
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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, 21 CFR part 
202 is amended as follows:

PART 202--PRESCRIPTION DRUG ADVERTISING

0
1. The authority citation for part 202 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 352, 355, 360b, 371.


0
2. In Sec.  202.1, add introductory text and revise paragraph (e)(1) to 
read as follows:


Sec.  202.1  Prescription-drug advertisements.

Prescription drug as used in this section means any drug defined in 
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or Sec.  
201.105 of this chapter, applicable to drugs intended for use by humans 
and to veterinary drugs, respectively.
* * * * *
(e) * * *
(1) When required. All advertisements for any prescription drug, 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:
(A) 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, unless required by 
paragraph (e)(1)(ii)(C) of this section to present the major statement 
using audio and text; and
(B) Contain a brief summary of all necessary information related to 
side effects and contraindications, unless adequate provision is made 
for dissemination of the approved or permitted product labeling in 
connection with the broadcast presentation.
(ii) Human drug advertisements in television or radio format--Clear, 
conspicuous, and neutral manner. For advertisements for prescription 
drugs intended for use by humans presented directly to consumers in 
television or radio format, the major statement must be presented in a 
clear, conspicuous, and neutral manner. The major statement is 
presented in a clear, conspicuous, and neutral manner if the following 
are met:
(A) It is presented in consumer-friendly language and terminology that 
is readily understandable.

[[Page 80984]]

(B) Its audio information, in terms of the volume, articulation, and 
pacing used, is at least as understandable as the audio information 
presented in the rest of the advertisement.
(C) In advertisements in television format, it is presented 
concurrently using both audio and text (dual modality). To achieve dual 
modality:
(1) Either the text displays the verbatim key terms or phrases from the 
corresponding audio, or the text displays the verbatim complete 
transcript of the corresponding audio; and
(2) The text is displayed for a sufficient duration to allow it to be 
read easily. For purposes of the standard in this paragraph 
(e)(1)(ii)(C)(2), the duration is considered sufficient if the text 
display begins at the same time and ends at approximately the same time 
as the corresponding audio.
(D) In advertisements in television format, for the text portion of the 
major statement, the size and style of font, the contrast with the 
background, and the placement on the screen allow the information to be 
read easily.
(E) During the presentation of the major statement, the advertisement 
does not include audio or visual elements, alone or in combination, 
that are likely to interfere with comprehension of the major statement.
* * * * *

    Dated: November 8, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-25428 Filed 11-20-23; 8:45 am]
BILLING CODE 4164-01-P