Federal Register / Vol. 80, No. 8 / Tuesday, January 13, 2015 / Notices 1637 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–00268 Filed 1–12–15; 8:45 am] 

BILLING CODE 4163–18–P 

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 Directto-Consumer Prescription Drug 

Television Advertisements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
1638 Federal Register / Vol. 80, No. 8 / Tuesday, January 13, 2015 / Notices 

TABLE 1—STUDY DESIGN

Medical condition Disclosure regarding additional risks 

Major statement 

Version 1 Version 2 

Depression .................................................................... Present .........................................................................

Absent ...........................................................................

A 

C 

B 

D 

High Cholesterol ........................................................... Present .........................................................................

Absent ...........................................................................

E 

G 

F 

H 

Insomnia ....................................................................... Present .........................................................................

Absent ...........................................................................

I 

K 

J 

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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 8 / Tuesday, January 13, 2015 / Notices 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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
1640 Federal Register / Vol. 80, No. 8 / Tuesday, January 13, 2015 / Notices 

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 ‘‘ByInvitation-Only’’ approach and through 

tailored online marketing with over 300 

diverse online affiliate partners and 

targeted Web site advertising. 

Specifically, Research Now uses eRewards® ‘‘By-Invitation-Only’’ 

recruitment methodology to invite prevalidated 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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 8 / Tuesday, January 13, 2015 / Notices 1641 

1We 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. 

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 tradeoff 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. 

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 tollfree 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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
1642 Federal Register / Vol. 80, No. 8 / Tuesday, January 13, 2015 / Notices 

2http://www.fda.gov/downloads/Regulatory

Information/Guidances/ucm125064.pdf. 

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. 

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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 8 / Tuesday, January 13, 2015 / Notices 1643 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Disclosure regarding 

additional risks in DTC 

prescription drug TV ads 

Number of respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Pilot Study Screener .......... 1700 (insomnia), 539 (high cholesterol), 3774 

(depression).

1 6,013 0.03 (2 minutes).180 

Main Study Screener .......... 4252 (insomnia), 1347 (high cholesterol), 9433 

(depression).

1 15,032 0.03 (2 minutes).451 

Pilot Study .......................... 600 (200 for each medical condition) ................... 1 600 0.50 (30 minutes).300 

Main Study ......................... 1500 (500 for each medical condition) ................. 1 1500 0.50 (30 minutes).750 

Total ............................ ........................................................................... ........................ ........................ ................ 1,681 

1There 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Organ 

Transplantation Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on Organ 

Transplantation (ACOT). 

Date And Time: January 27, 2015, 

from 12:30 p.m. to 4:30 p.m. Eastern 

Standard Time. 

Place: The meeting will be via audio 

conference call and Adobe Connect Pro. 

Status: The meeting will be open to 

the public. 

Purpose: Under the authority of 42 

U.S.C. Section 217a, Section 222 of the 

Public Health Service Act, as amended, 

and 42 CFR 121.12 (2000), ACOT was 

established to assist the Secretary in 

enhancing organ donation, ensuring that 

the system of organ transplantation is 

grounded in the best available medical 

science, and assuring the public that the 

system is as effective and equitable as 

possible, thereby increasing public 

confidence in the integrity and 

effectiveness of the transplantation 

system. ACOT is composed of up to 25 

members including the Chair. Members 

serve as Special Government Employees 

and have diverse backgrounds in fields 

such as organ donation, health care 

public policy, transplantation medicine 

and surgery, critical care medicine, and 

other medical specialties involved in 

the identification and referral of donors, 

non-physician transplant professions, 

nursing, epidemiology, immunology, 

law and bioethics, behavioral sciences, 

economics and statistics, as well as 

representatives of transplant candidates, 

transplant recipients, organ donors, and 

family members. 

Agenda: The Committee will hear 

presentations including those on the 

following topics: Kidney Paired 

Donation, Vascularized Composite 

Allografts; the HOPE Act; and 

recommendations sent to the Secretary. 

Agenda items are subject to change as 

priorities indicate. 

After Committee discussions, 

members of the public will have an 

opportunity to comment. Because of the 

Committee’s full agenda and timeframe 

in which to cover the agenda topics, 

public comment will be limited. All 

public comments will be included in 

the record of the ACOT meeting. 

Meeting summary notes will be posted 

on Department’s organ donation Web 

site at http://www.organdonor.gov/

legislation/advisory.html#meetings. 

The draft meeting agenda will be 

posted on www.blsmeetings.net/ACOT. 

Those participating in this meeting 

should register by visiting 

www.blsmeetings.net/ACOT. The 

deadline to register for this meeting is 

Monday, January 26, 2015. For all 

logistical questions and concerns, please 

contact Anita Allen, Seamon 

Corporation at 301–658–3442 or send an 

email to 

aallen@seamoncorporation.com. 

The public can join the meeting by: 

1. (Audio Portion) Calling the 

Conference Phone Number (888–324– 

4391) and providing the Participant 

Code (2426); and 

2. (Visual Portion) Connecting to the 

ACOT Adobe Connect Pro Meeting 

using the following URL and entering as 

GUEST: 

https://hrsa.connectsolutions.com/

acot1/ (copy and paste the link into 

your browser if it does not work 

directly, and enter as a guest). 

Participants should call and connect 15 

minutes prior to the meeting for 

logistics to be set up. If you have never 

attended an Adobe Connect meeting, 

please test your connection using the 

following URL: https://hrsa.connect

solutions.com/common/help/en/

support/meeting_test.htm and get a 

quick overview by following URL: 

http://www.adobe.com/go/connectpro_

overview. Call (301) 443–0437 or send 

an email to ptongele@hrsa.gov if you are 

having trouble connecting to the 

meeting site. 

Public Comment: It is preferred that 

persons interested in providing an oral 

presentation email a written request, 

along with a copy of their presentation, 

to Patricia Stroup, MBA, MPA, 

Executive Secretary, Healthcare Systems 

Bureau, Health Resources and Services 

Administration, at pstroup@hrsa.gov. 

Requests should contain the name, 

address, telephone number, email 

address, and any business or 

professional affiliation of the person 

desiring to make an oral presentation. 

Groups having similar interests are 

requested to combine their comments 

and present them through a single 

representative. 

The allocation of time may be 

adjusted to accommodate the level of 

expressed interest. Persons who do not 

file an advance request for a 

presentation, but desire to make an oral 

statement, may request it during the 

public comment period. Public 

participation and ability to comment 

will be limited to time as it permits. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Stroup, MBA, MPA, Executive 


asabaliauskas on DSK5VPTVN1PROD with NOTICES