Document ID: FDA-2014-N-0168-0013
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Disclosure
Regarding Additional Risks in Directto-Consumer Prescription Drug
Television Advertisements
Posted Date: 2015-01-13T05:00Z

[Federal Register Volume 80, Number 8 (Tuesday, January 13, 2015)]
[Notices]
[Pages 1637-1643]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00269]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0168]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Disclosure Regarding 
Additional Risks in Direct-to-Consumer Prescription Drug Television 
Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit either electronic or written comments on the collection 
of information by February 12, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Disclosure Regarding Additional Risks in Direct-to-Consumer 
(DTC) Prescription Drug Television (TV) Advertisements (Ads).'' Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Disclosure Regarding Additional Risks in Direct-to-Consumer 
Prescription Drug Television

Advertisements--(OMB Control Number 0910-NEW)

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to 
conduct research relating to drugs and other FDA regulated products in 
carrying out the provisions of the FD&C Act.
    Prescription drug advertising regulations (21 CFR 202.1) require 
that broadcast (TV or radio) advertisements present the product's major 
risks in either audio or audio and visual parts of the advertisement; 
this is often called the ``major statement.'' There is concern that as 
currently implemented in DTC ads, the major statement is often too 
long, which may result in reduced consumer comprehension, minimization 
of important risk information and, potentially, therapeutic non-
compliance due to fear of side effects. At the same time, there is 
concern that DTC TV ads do not include adequate risk information or 
leave out important information. These are conflicting viewpoints. A 
possible resolution is to limit the risks in the major statement to 
those that are serious and actionable, and include a disclosure to 
alert consumers that there are other product risks not included in the 
ad. For example, the disclosure could be, ``This is not a full list of 
risks and side effects. Talk to your doctor and read the patient 
labeling for more information.'' The Office of Prescription Drug 
Promotion plans to investigate the effectiveness of this ``limited 
risks plus disclosure'' strategy through empirical research.
    Our primary hypothesis is that, relative to inclusion of the full 
major statement, providing limited risk information along with the 
disclosure about additional risks will promote improved consumer 
perception and understanding of serious and actionable drug risks. We 
will also investigate other questions such as whether overall drug risk 
and benefit perceptions are affected by these changes. To examine 
differences between experimental conditions, we will conduct 
inferential statistical tests such as analysis of variance. With the 
sample size described further in this document, we will have sufficient 
power to detect small-to-medium sized effects in the main study.
    Participants will be consumers who self-identify as having been 
diagnosed with one of three possible medical conditions: Depression, 
high cholesterol, or insomnia. All participants will be 18 years of age 
or older. We will exclude individuals who work in healthcare or 
marketing settings because their knowledge and experiences may not 
reflect those of the average consumer. Recruitment and administration 
of the study will take place over the Internet. Participation is 
estimated to take approximately 30 minutes.
    Within medical condition, participants will be randomly assigned to 
view one of four possible versions of a DTC ad, as depicted in table 1. 
One version will present the full major statement without the 
disclosure regarding additional risks (Conditions C, G, and K). This 
version will implement existing ads in the marketplace. Stimuli 
variations for the other three versions will be achieved by replacing 
the audio track of the original ad with the revised risk and disclosure 
statements described previously. Thus, a second version of the ad will 
include the full major statement plus the disclosure about additional 
risks (Conditions A, E, and I). A third version will include an 
abbreviated statement of risks without the disclosure about additional 
risks (Conditions D, H, and L). The fourth version will include an 
abbreviated statement of risks as well as the disclosure about 
additional risks (Conditions B, F, and J).
    After viewing the ad, participants will respond to questions about 
information in the ad. Measures are designed to assess perception and 
understanding of product risks and benefits; perception and 
understanding of the disclosure about additional risks; perceptions of 
product quality; intention to seek more information about the product; 
and perceptions of trust/skepticism regarding product claims and the 
sponsor. The questionnaire is available upon request.

[[Page 1638]]

                                              Table 1--Study Design
----------------------------------------------------------------------------------------------------------------
                                                                                         Major statement
              Medical condition                Disclosure regarding additional ---------------------------------
                                                            risks                  Version 1        Version 2
----------------------------------------------------------------------------------------------------------------
Depression...................................  Present........................               A                B
                                               Absent.........................                C               D
High Cholesterol.............................  Present........................               E                F
                                               Absent.........................               G                H
Insomnia.....................................  Present........................               I                J
                                               Absent.........................               K                L
----------------------------------------------------------------------------------------------------------------
Note. Version 1 = current major statement; Version 2 = abbreviated major statement.

    In the Federal Register of February 18, 2014 (79 FR 9217), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received comments from 26 groups or 
individuals in response to our Federal Register notice. This amounted 
to 55 comments that specifically referenced the study and were PRA-
related.
    FDA's specific responses to the comments are divided into sections. 
The first section addresses pharmaceutical industry comments from the 
Pharmaceutical Research and Manufacturers of America (PhRMA), Abbvie, 
Pfizer, and Eli Lilly and Company. The second section addresses 
comments from other organizations, including the Patient, Consumer, and 
Public Health Coalition, Washington Legal Foundation, Consumers Union, 
and Coalition for Healthcare Communication. The third section addresses 
comments from individuals (names indicated in-text when available). 
Many commenters indicated support for this research. We appreciate this 
support. Comments that are not PRA-relevant (e.g., ``Ban DTC'') or do 
not relate to the proposed study are not included in this document or 
addressed in our responses. For brevity, all public comments are 
paraphrased and therefore may not reflect the exact language used by 
the commenter. We assure commenters that the entirety of their comments 
was considered even if not fully captured by our paraphrasing in this 
document.

Responses to Comments From the Pharmaceutical Industry

PhRMA

1. Use of an existing drug ad could have confounding results due to 
consumer familiarity with medicines and drug classes used to treat 
their existing condition.
    Response: The decision to implement and modify existing ads was 
arrived at in an effort to balance the integrity of the research with 
cost considerations. It is significantly less expensive to implement 
and modify existing ads than it is to create and modify fictitious ads. 
Nonetheless, we appreciate this concern and in response, we have added 
questions to the survey to measure ad familiarity, which we can then 
control for in our analyses.
2. If FDA goes forward with the strategy to use existing ads, (a) avoid 
using a drug ad that has aired within the past 12 months or that 
contains any iconic images or marks, (b) alter the brand and 
established names of the drugs, (c) record a new voiceover for the 
major statement using fictionalized risk information, and (d) ensure 
that fictionalized risks are not similar to or associated with related 
drugs.
    Response: We do not intend to fictionalize the risks and side 
effects or brand and established names. Our goal in using existing 
information is to ensure external validity of study findings when we 
draw comparisons between consumers who view existing versus modified 
risk statements. We intend to control for familiarity by measuring ad 
familiarity.
3. Participant sample should consist of consumers who self-identify as 
having the disease the drug featured in the ad treats.
    Response: As stated in Federal Register Notice, ``participants will 
be consumers who self-identify as having been diagnosed with one of 
three possible medical conditions.'' The medical condition diagnosed 
will be consistent with the medical condition targeted by the 
advertising.

Abbvie

1. Ask participants to identify the name of the drug prior to asking 
about benefits and risks.
    Response: Participants in this research will see only one drug ad 
and therefore perceptions will necessarily be associated with that one 
drug. It is outside the scope of this project to investigate drug name 
recall and/or recognition. Therefore, to avoid unnecessarily burdening 
participants, we do not intend to include these questions.
2. Include patients across a wider range of ages and with acute 
conditions.
    Response: We proposed to recruit participants 18 years of age and 
older who self-identify as having been diagnosed with the medical 
condition being advertised. We considered many variables in choosing 
the conditions to test, including acute versus chronic conditions. We 
acknowledge that the type of condition (for example, acute, 
symptomatic, chronic, silent) may interact with the risk profile of the 
product (for example, very risky to less risky). With these variables 
in mind, we chose conditions that represent chronic and symptomatic 
diseases and a range of risk profiles.
3. Add a question to ascertain that participants can identify risks of 
the drug.
    Response: Risk recall is currently assessed by Q6. Risk recognition 
is currently assessed by Q7.
4. Regarding Q8, if a fact-based statement was presented, it would be 
valuable to word the question to see if respondents comprehend the 
statement.
    Response: Q8 (now Q9) reads, ``In your opinion, if [DRUG] did help 
a person's [condition], how much would it help?'' The purpose of this 
question is to assess anticipated efficacy magnitude of the drug based 
on the advertising. This question has been subject to cognitive testing 
and refinement in other FDA research, confirming that respondents 
understand and are able to respond to this question.
5. Regarding Q18 and Q19 (Q23 and Q24 in revised questionnaire):
    a. These questions assume that participants are knowledgeable about 
alternative treatments; if they are knowledgeable, it is unclear what 
treatment participants might select as a comparator.

[[Page 1639]]

    Response: We agree with this concern. In response, we have added 
language introducing these questions. The language reads, ``Please 
think about other medicines you know of that treat [condition]. If you 
are not aware of other medicines that treat [condition], please choose 
the answer [Neither disagree nor agree].'' Additionally, following Q23 
and Q24, we intend to inquire which drug(s) participants had in mind 
with an open-ended question.
    b. The focus of the questions should be on how to interpret the 
information when presented with all risks versus only major and most 
likely risks.
    Response: The purpose of these questions is to assess anticipated 
efficacy and risk relative to other medicines that treat the condition. 
By drawing comparisons between the experimental conditions, we will be 
able to assess if anticipated efficacy and risk relative to other 
medicines differs due to exposure to the existing set of risks versus 
an abbreviated set (Condition 1) and whether or not a disclosure is 
presented (Condition 2).
    c. A question should be added to ascertain if respondents can 
identify major risks of the drug.
    Response: Risk recall is currently assessed by Q6. Risk recognition 
is currently assessed by Q7.
    d. To assess participant ability to balance the risks of the drug 
with its benefits, respondent's knowledge of the effectiveness of the 
drug should be queried using a 5 or 7 point scale anchored from Not 
Effective to Very Effective.
    Response: The purpose of Q23 and Q24 is not to assess risk-benefit 
tradeoff. See response to comment 5b for the purpose of these 
questions. Note also that a number of questions already assess 
anticipated effectiveness of the drug (e.g., Q8 and Q9). Risk-benefit 
tradeoff is assessed by Q12 and Q13a-c.
6. Reword Q26 get the respondent to focus on the format of the 
information presentation versus how the study was executed.
    Response: The language of this question (now Q28) has been 
reformatted to include the specific disclosure language. The purpose of 
this question is to assess noticeability and understanding of the 
concept that not all risks were presented. Later questions (e.g., Q29a) 
assess understanding of the specific statement wording.
7. Add questions to assess how informative and actionable participants 
found the list of risks and side effects.
    Response: We agree with this suggestion and have now incorporated 
questions into the survey to assess these reactions.

Pfizer

1. It may prove difficult for respondents to quantify risk and benefit 
in Q7 and Q9 given that the ads will not explicitly quantify risk or 
benefit information; FDA should use these data only to assess relative 
differences across ad treatments.
    Response: The purpose of these questions (now Q8 and Q10) is to 
assess perceived benefit and risk based on the advertising shown. We do 
not expect participants to quantify benefits and risks as they were 
empirically measured.
2. Avoid asking participants how other people will react.
    Response: We agree with this suggestion and have revised the 
questionnaire accordingly.
3. Q18 and Q19 may prove difficult to interpret. Given that 
participants have not seen the revised major statements before, they 
may perceive drugs in the test ads to be more or less effective simply 
because other drugs advertised on TV are not using these formats. If 
implemented broadly, the comparative effect would likely go away.
    Response: We appreciate the possibility that findings obtained in 
this study may differ from outcomes once implemented broadly. Still, it 
is important to measure these constructs. Findings from this study are 
one of a number of factors that would be considered prior to broad 
implementation in broadcast advertisements. These questions are 
reflected in Q23 and Q24 in the revised questionnaire.
4. Add questions to assess how clear, confusing, and important 
participants found the list of risks and side effects; also assess 
whether participants felt too much risk information and not enough risk 
information was presented.
    Response: We agree with these suggestions and have incorporated 
questions into the survey that assess these constructs.
5. Delete Q11; the ads likely do not provide information about how easy 
or difficult it is to treat the condition with the drug.
    Response: We agree with this suggestion and have modified the 
questionnaire accordingly.
6. Delete Q17; persuasiveness of the ad is subjective and difficult for 
respondents to assess.
    Response: Our intention in asking this question (now Q26d) is to 
determine if displaying only serious and actionable risks along with a 
disclosure results in perceptions that the ad is more persuasive. We 
believe this is an important construct to measure and therefore will 
retain the question. Additionally, we have added Q17 (``I am interested 
in trying [DRUG]'') as an indirect measure of persuasion.
7. Delete Q23; it is not clear how respondents would be able to assess 
the quality of the drug.
    Response: Our intention in asking this question (now Q25) is to 
determine if displaying only serious and actionable risks along with a 
disclosure results in perceptions that the drug is of high quality. 
This perception is based exclusively on the advertising and not on 
quality as it might be measured empirically. To clarify this intention, 
we have added instructions indicating that judgments should be reached 
based on the information in the prescription drug ad. We believe 
perceived drug quality an important construct to measure and therefore 
will retain the question.
8. Delete Q29a-d; it is not clear how assessing skepticism is relevant 
to the study objectives.
    Response: Due to concerns about the length of the questionnaire, we 
have deleted these questions.

Eli Lilly and Company

1. Include a general population control group.
    Response: The decision not to include a general population sample 
was arrived at in an effort to balance the integrity of the research 
with cost considerations. Each medical condition, or general population 
sample, comes at significant cost. The medical conditions we chose were 
selected because they represent conditions that are both chronic, 
symptomatic, and have a range of risk profiles (see response to Abbvie 
Comment 2). Although we appreciate the value of collecting data on a 
general population sample, we do not intend to adopt this suggestion in 
the present research based on cost considerations.

[[Page 1640]]

2. Immediately following unaided recall (Q1b; now Q3) and category 
assignments (Q2 and Q3; Q2 now deleted, Q3 now Q4), it is advised that 
close-ended questions assessing respondents' perception of whether the 
information in the ad is easily understood (similar to Q20 battery; now 
Q13) be added.
    Response: We agree that these questions are important and central 
to the research objectives, and so we have placed these questions 
earlier in the revised questionnaire. However, we are unclear on the 
rationale for inquiring about these topics immediately following Q4. We 
plan to instead measure recall and recognition of benefits and risks 
before inquiring about the clarity in presentation of benefits and 
risks. We believe that involvement in answering recall and recognition 
questions first will allow consumers to provide a more accurate 
assessment of whether the information is easily understood.
3. Several questions (Q7, Q8, Q9, Q11, Q18, Q19, and Q23) appear to 
lack relevance to the research objectives and should be modified or 
deleted.
    Response: The purpose of Q7, Q8, and Q9 (now Q8 through Q11) is to 
assess perceived benefit and risk of taking the drug. The purpose of 
Q18 and Q19 (now Q23 and Q24) is to assess anticipated efficacy and 
risk relative to other medicines that treat the condition. The purpose 
of Q23 (now Q25) is to assess perceived quality of the drug. We have 
modified these questions to communicate that perceptions should be 
based on the impression participants received from the advertising. By 
drawing comparisons between the experimental conditions, we may 
determine that the risk and disclosure statements alter the previously 
mentioned perceptions. We agree that Q11 lacks direct relevance to the 
research objectives and therefore have deleted this item.
4. Q36 suggests that participants may be allowed to complete the study 
using a mobile device; pre-testing should be conducted to determine the 
appropriateness of this option.
    Response: We intend to restrict participants to using devices that 
allow full functionality of study procedures. We will retain a modified 
version of Q36 (now Q39) to ascertain that this requirement was 
followed.
5. Provide instructions to respondents regarding ad downloading/
buffering to ensure they can see and hear the stimuli.
    Response: We agree with this suggestion and intend to implement it.
6. Maintain consistent scale parameters throughout the survey to avoid 
confusion by participants and reduce bias in analysis.
    Response: We agree with this recommendation and have adopted it in 
cases where the specific scale has not been validated by prior 
research.
7. Terms in Q2 (e.g., over-the-counter drug) should be defined or 
presented in consumer friendly language.
    Response: Due to concerns about the length of the questionnaire, we 
have deleted this question.
8. In Q3, the response option ``High Blood Pressure'' may confuse 
participants who are diagnosed with both high cholesterol and high 
blood pressure; consider an alternative condition for high blood 
pressure.
    Response: We agree with this recommendation and have replaced 
``high blood pressure'' with ``seasonal allergies.'' Q3 is reflected in 
Q4 in the revised questionnaire.
9. Q13, Q14, and Q15 (Q18 through Q22 battery in revised questionnaire) 
should be modified so that the respondent would indicate intention or 
likelihood for themselves, without asking them to project to others.
    Response: We agree with this recommendation and have modified these 
questions accordingly.
10. Improve programming instructions to clarify which respondents are 
asked Q27 and Q28 versus those that are skipped to Q29.
    Response: Participants in conditions in which the risk disclosure 
is not shown are skipped to Q30 in revised questionnaire. We have 
clarified this intention in the programming language.

Responses to Comments From Other Groups and Organizations

Patient, Consumer, and Public Health Coalition (PCPHC)

1. Define ``serious and actionable.''
    Response: We define ``actionable'' as something the patient would 
know (e.g., pre-existing condition or allergy) or recognize (e.g., 
observable physical or mental symptom) and can act upon to help 
mitigate (e.g., get immediate medical help to prevent a bad outcome). 
For example, ``stop using the product and get immediate medical help if 
you have swelling of the face, lips, tongue, or throat.'' Serious risks 
would include those that appear in the warnings and precautions section 
of labeling and results in any of the following outcomes: Death, a 
life-threatening adverse drug experience, inpatient hospitalization or 
prolongation of existing hospitalization, a persistent or significant 
disability/incapacity, or a congenital anomaly/birth defect. Important 
medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered a serious adverse drug 
experience when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical 
intervention to prevent one of the outcomes listed previously.
2. Ensure a diverse participant sample: Internet recruitment may favor 
inclusion of younger, more affluent and Internet-adept populations; the 
medical conditions chosen may not adequately reflect the general U.S. 
consumer audience.
    Response: The rapid expansion of Internet access across the U.S. 
population has made panel participation feasible for an increasingly 
broader range of respondents. Still, there are some demographic groups 
that are more responsive than others; but that can be found across all 
research methodologies. For example, there is a natural skew on those 
that will take a research phone call and those that will attend a focus 
group. The same can be said for Internet research as well. To rectify 
those skews, we utilize the Research Now panel, which is recruited to 
match a natural distribution of all demographic groups. Research Now 
works with clients to set fixed quota expectations in the survey 
instrument itself to enforce the final distribution and work with the 
invitation mix to balance the outcome as needed during the field 
period. Research Now's panels are recruited through a partner network 
of ubiquitous brands utilizing a ``By-Invitation-Only'' approach and 
through tailored online marketing with over 300 diverse online 
affiliate partners and targeted Web site advertising. Specifically, 
Research Now uses e-Rewards[supreg] ``By-Invitation-Only'' recruitment 
methodology to invite pre-validated individuals to participate in their 
Consumer and Business Panels. Their recruitment methods provide a 
sample mix representative of the general population and also provide 
access to hard-to-reach business professionals and low-incidence 
consumers who are

[[Page 1641]]

typically less likely to join panels. Research Now controls and manages 
the demographic make-up of their panels and enrolls individuals who 
share known characteristics--ensuring access to populations of interest 
to the study. Their panels also comply with, or exceed, all applicable 
industry standards published by: ESOMAR, Market Research Society 
(U.S.), Australian Market & Social Research Society (Australia), 
Berufsverband Deutscher Markt--und Sozialforscher e.V. (Germany), 
Council of American Survey Research Organizations (U.S.), and Marketing 
Research and Intelligence Association (Canada).
    Regarding choice of medical conditions, we considered many 
variables in choosing the conditions to test, including acute versus 
chronic conditions. We acknowledge that the type of condition (for 
example, acute, symptomatic, chronic, silent) may interact with the 
risk profile of the product (for example, very risky to less risky). 
With these variables in mind, we chose conditions that represent 
chronic and symptomatic diseases and a range of risk profiles.
3. Study conditions must be as similar to real life situations as 
possible.
    Response: Because this is the first test of abbreviated risk 
statements with disclosures, our primary goal is to closely examine the 
cognitive effects of exposure to the test ads in a controlled 
experiment. As such, internal validity is a greater priority than 
external validity. We considered presenting test ads within a clutter 
reel to help mimic real world conditions, but worry that this approach 
may introduce unwanted bias (e.g., how attention-getting the test ad is 
compared to the filler ads). To increase study realism without 
sacrificing internal validity, we have chosen a sample that would 
potentially be interested in the drug. In addition, modified ads will 
be professionally developed and appear realistic.
4. Examine presentation of major statement earlier in the 
advertisement, when a greater proportion of consumers may be paying 
attention.
    Response: We recognize the value of asking this question; consumers 
may respond differently if the major statement was to be presented 
earlier in an advertisement. However, this is a different research 
question than proposed by the present study and so we do not intend to 
address it in this research. We encourage other researchers to pursue 
this unique empirical question.

Washington Legal Foundation

1. Supports the proposed collection and requests that it be expanded to 
test an alternative hypothesis that the average consumer is very 
unlikely to be ``misled into believing that the drug poses no 
significant health risks for him'' if a broadcast DTC advertisement for 
the drug ``alerts consumers to its potential benefits, states generally 
that taking the drug poses significant potential health risks, lists 
any types of individuals who are categorically contra-indicated for the 
drug, and then asks the consumer to consult with his doctor for a more 
detailed explanation of risks,'' and to include a First Amendment 
analysis.
    Response: FDA appreciates the support for the proposed collection. 
However, FDA declines to expand the scope of this proposed information 
collection as suggested. The primary objective of the proposed study is 
to assess whether consumer perception and understanding of serious and 
actionable drug risks is improved if DTC television ads for 
prescription drugs present limited information focused on those serious 
and actionable risks together with a disclosure that there are 
additional risks, as compared to a broader presentation of risk 
information without disclosure that there are additional risks, like 
that commonly used in TV ads today. The presentation of risk 
information about prescription drugs to consumers implicates multiple 
important public health concerns, including how the presentation of 
both risk and benefit influences consumer judgments about the risk-
benefit trade-off of advertised drugs, and how it impacts consumer 
decisions about whether or not to approach a healthcare provider about 
advertised drugs.
    In considering how to allocate its limited resources for research, 
FDA must make choices and has identified its initial hypothesis as a 
useful one to help improve understanding of how different approaches in 
DTC television advertisements can impact consumer perception and 
understanding of drug risks. Once this proposed research is complete 
and published, the results will facilitate further consideration and 
analysis, including by outside entities, and may suggest additional 
topics for research.
    A First Amendment analysis is likewise outside the scope of the 
current proposed research and FDA therefore declines to redesign the 
study along the lines suggested by the comment.\1\ Of course, when FDA 
implements its regulatory program, it does so in a manner that seeks to 
promote and protect the public health, consistent with its statutory 
authorities and mandate, while harmonizing this goal with First 
Amendment interests.
---------------------------------------------------------------------------

    \1\ We also note that we disagree with several aspects of the 
comment's assertions related to First Amendment law, but we do not 
believe it is necessary or appropriate to address those arguments 
here.
---------------------------------------------------------------------------

Consumers Union

1. Define ``serious and actionable.''
    Response: Please see our response to PCPHC Comment 1.
2. The proposed study could lead to replacing the current requirement 
to reference where to get full drug/device information with a mere 
mention that there are more side effects.
    Response: Adequate provision refers to elements in a broadcast ad 
describing ways viewers can get the full product labeling, such as 
through the manufacturer's Web site, through a print ad, by calling the 
manufacturer's toll-free number, and by asking their healthcare 
provider. The proposed research was not designed to inform whether 
adequate provision should or should not remain in DTC advertising, and 
therefore the study results should not be used for such purposes.
3. The study procedures should reflect the way an average consumer 
would see or hear an ad (e.g., when the consumer's focus is not 
necessarily on the ad).
    Response: Please see our response to PCPHC Comment 3.

Coalition for Healthcare Communication

1. Include a qualitative leg to the study.
    Response: Although adding a qualitative leg to the study would 
likely generate interesting and insightful outcomes, cost 
considerations restrict us from doing so. Note however that we do 
intend to conduct cognitive interviews prior to administration of the 
main study. Cognitive interviews involve a trained interviewer who will 
sit with participants as they view the stimuli, complete the 
questionnaire, and discuss their thought processes out loud, prompting 
participants to explain why they answered certain questions as they 
did. Findings from the cognitive interviews will then inform 
development of the final stimuli and questionnaire.
2. Include physicians in the study.
    Response: We agree that physician perspectives about prescription 
drug advertising are important and

[[Page 1642]]

interesting. However, as their perspective is outside the scope of the 
current research, we do not intend to adopt this suggestion. Note that 
we recently completed a separate study examining this topic, entitled 
``Healthcare Professional Survey of Prescription Drug Promotion.'' 
Results from this study will be made available in the peer-reviewed 
literature.
3. Recruit respondents and analyze results by age cohort.
    Response: We agree that recruiting participants across a wide range 
of ages is important and our sample will reflect this shared 
perspective.
4. Consider including communication media beyond television.
    Response: We understand that it is important to understand effects 
of prescription drug advertising across mediums. Commonalities exist 
across multiple communication mediums, but also differences that may 
impact consumer perception of drug benefits and risks. Consequently, 
our research program has investigated various topics across these 
mediums. We intend to focus on television advertising in this study 
because it is most closely related to the research objectives, and due 
to cost considerations.
5. Reconsider using existing DTC ads in the proposed study.
    Response: Please refer to our response to PhRMA comments 1 and 2.
6. Clearly define what ``serious and actionable'' risks are.
    Response: Please refer to our response to PCPHC comment 1.

Responses to Comments From Individuals

Mel Sokotch

1. To ensure ad presentation is consistent with real world viewing 
conditions, the test ad should be presented as part of a clutter reel.
    Response: Please refer to our response to PCPHC comment 3.
2. Immediately following the clutter reel with test ad inserted, 
initial survey questions should include open-ended assessment of issues 
such as recall, communication, and motivation. The ad should then be 
presented again and followed by additional questions designed to assess 
the impact of the ad.
    Response: Our current procedures involve two presentations of the 
ad: once prior to administering the questionnaire and once during the 
questionnaire immediately preceding specific questions about the risk 
disclosure statement. To avoid unnecessarily burdening participants, we 
do not intend to show the ad a third time, per this recommendation.

Anonymous

1. As an end consumer, the side effects listed give us information to 
research further to determine the severity of the side effects.
    Response: We address this concern by asking participants, in open-
ended fashion, to list the thoughts that were going through their mind 
as they viewed the ad. In doing so, we hope to learn whether this is a 
broad concern among consumers. We are also assessing perceptions of 
risk.
2. Prescription drug commercials seek to persuade consumers, and 
healthcare providers have little time to discuss these risks and side 
effects with patients; thus, providing this information in television 
advertisements is important and necessary.
    Response: Current regulations (21 CFR 202.1(e)(1)) require that 
prescription drug broadcast advertisements present the major risks of 
the drug as well as provide adequate provision, or mention of where the 
patient can obtain additional information about risks and side effects 
of the drug (e.g., Web sites, magazines). We recognize that providing 
risk information is an important and necessary component. As stated in 
the Federal Register, however, there is also concern that the length 
and content of some major statements is not adequately communicating 
this important information. Thus, we are conducting empirical research 
to test this question. This study does not address the question of 
adequate provision.

John Bonanno; Aaron Heyman; Thomas Klugh (Similar Comment)

1. All warnings should be clearly stated.
    Response: Per 21 CFR 202.1, current regulations require that 
broadcast ads disclose the product's major risks; these are typically 
the most common and the most serious risks described in labeling. At 
the same time the full product labeling should be made available 
through other means (see Guidance for Industry: Consumer-Directed 
Broadcast Advertisements \2\). With this in mind, the current study is 
addressing the impact of the current major statement risk format versus 
an abbreviated format, along with a disclosure indicating that not all 
risk information was presented.
---------------------------------------------------------------------------

    \2\ http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125064.pdf.
---------------------------------------------------------------------------

John Sovitsky

1. Existing regulations do not go far enough; warnings should be 
described in text as large as benefits, and spoken at a slower, more 
intelligible speed.
    Response: Although interesting, this comment is outside the scope 
of the present research.

Duane De Vries; Gary Graham (Similar Comment)

1. Consumers need all of the information that they can get to protect 
them against unscrupulous drug companies.
    Response: Please see response to previous comment.

Nila Jamerson; Charles McCloud (Similar Comment)

1. Risk disclosures in drug ads are tedious and unneeded; they should 
be provided by healthcare providers.
    Response: Communication between healthcare providers and patients 
about drug risks is an important component of the healthcare decision 
making process. Nonetheless, the regulations require that benefit 
information in prescription drug ads should be balanced with 
presentation of risk information so that consumers can adequately 
consider both benefits and risks (i.e., the risk-benefit trade off) 
before approaching a healthcare provider about the drug.

Janessa

1. Additional risks should remain in TV ads; otherwise, advertised 
drugs sound like cure-all miracles.
    Response: Note that we do not propose studying whether all risk 
information should be eliminated from broadcast ads. In both the 
current major statement condition and the experimental condition with 
abbreviated major statement plus disclosure, significant risks 
associated with the drug are presented in broadcast advertisements. 
Thus, we do not agree that the presentation would imply a cure-all 
miracle.

Patricia Simon

1. The number of participants is far too few.
    Response: Sample size per experimental condition in the main study 
is 125. This sample size is based on a statistical power analysis with 
power set at .90 and alpha equal to .05 assuming a small to medium 
effect size. Thus, power analyses support that our sample size is 
adequate.

[[Page 1643]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 Number of
Disclosure regarding  additional risks in        Number of respondents         responses per   Total annual   Average  burden per  response  Total hours
      DTC  prescription drug TV ads                                             respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot Study Screener.....................  1700 (insomnia), 539 (high                      1           6,013  0.03 (2 minutes).............          180
                                            cholesterol), 3774 (depression).
Main Study Screener......................  4252 (insomnia), 1347 (high                     1          15,032  0.03 (2 minutes).............          451
                                            cholesterol), 9433 (depression).
Pilot Study..............................  600 (200 for each medical                       1             600  0.50 (30 minutes)............          300
                                            condition).
Main Study...............................  1500 (500 for each medical                      1            1500  0.50 (30 minutes)............          750
                                            condition).
LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL                                                   -----------------------------------------------
    Total................................  .................................  ..............  ..............  .............................        1,681
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: January 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00269 Filed 1-12-15; 8:45 am]
BILLING CODE 4164-01-P