[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18407-18410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0554]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Comparative Price 
Information in Direct-to-Consumer and Professional Prescription Drug 
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: Fax written comments on the collection of information by May 6, 
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 [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title, ``Comparative Price Information in Direct-to-Consumer and 
Professional Prescription Drug Advertisements.'' 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, [email protected].

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.

Comparative Price Information in Direct-to-Consumer and Professional 
Prescription Drug Advertisements--(0910-NEW)

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes the 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(d)(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.
    By their very nature, medical and health decisions are comparative 
(e.g., treat versus not treat). For consumers, these decisions may 
include the use of prescription drug products versus over the counter 
products versus herbal supplements, as well as one prescription brand 
versus another prescription brand. Similarly, advertising is often 
comparative. In prescription drug advertising, sponsors are permitted 
to include truthful, non-misleading information about the price of 
their products in promotion. This may extend to price comparison 
information, wherein sponsors may include information about the price 
of a competing product in order to make advantageous claims. Currently, 
when price comparisons are made, the advertisement (ad) should also 
include context that the two drugs may not be comparable in terms of 
efficacy and safety and that the acquisition costs presented do not 
necessarily reflect the actual prices paid by consumers, pharmacies, or 
third party payers. Despite the inclusion of this additional 
information, there is concern that adding contextual information about 
efficacy or safety is not sufficient to correct the impression that the 
products are interchangeable and that price is the main factor to 
consider. The Office of Prescription Drug Promotion plans to 
investigate, through empirical research, the impact of price comparison 
information and additional contextual information on prescription drug 
product perceptions. This will be investigated in direct-to-consumer 
(DTC) and healthcare-directed professional advertising for prescription 
drugs.

Design Overview and Procedure

    The design consists of two pretests and a main study. We will 
conduct two sequential pretest waves prior to main data collection. The 
purpose the pretests are to: (1) Ensure the stimuli are understandable 
and viewable; (2) identify and address any challenges to embedding the 
stimuli within the online survey; and (3) ensure the study questions 
are appropriate and meet the study's goals. Participants in the 
pretests will be randomly assigned to one of two versions of an ad. One 
version will present information about the price of the product 
relative to a competitor for the same indication (Price Comparison). 
Another version will present this information with additional 
contextual information that the two drugs may not be comparable in

[[Page 18408]]

terms of efficacy and safety and that the acquisition costs do not 
necessarily reflect actual prices paid (Price Comparison + Additional 
Context).
    Participants in Pretest 1 will be consumers (n=400) who self-
identify as having been diagnosed with diabetes. Pretest 2 will be 
conducted with physicians (n=1,000) who are General Practitioners 
(e.g., Family Practice, General Practice, Internal Medicine) and 
Specialists (e.g., Endocrinology, Pain Management). Pretest 2 has a 
two-fold purpose. In addition to the measurement and stimuli 
verification issues identified above, we will also conduct an 
experiment to evaluate the impact of incentive level (level 1 vs. level 
2) and study sponsorship (FDA vs. Public Health Agency) disclosure on 
physician response rates (see Exhibit 1). Pretest 2 will therefore 
provide a comparison of recruitment approaches, identify ways to 
optimize response rates, and provide a ``dry run'' of experimental 
study recruitment procedures.

                                     Exhibit 1--Pretest 2 Design, Incentive Level by Study Sponsorship by Type of Ad
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Type of ad
                                                                         ----------------------------------------------------------------
                                                                                 Price comparison          Price comparison + additional
              Study sponsor                                              --------------------------------             context                  Total
                                                                                                         --------------------------------
                                                                                FDA        Public Health                   Public Health
                                                                                              Agency            FDA           Agency
--------------------------------------------------------------------------------------------------------------------------------------------------------
Incentive Level..........................  Level 1......................             125             125             125             125             500
                                           Level 2......................             125             125             125             125             500
                                                                         -------------------------------------------------------------------------------
    Total................................  .............................             250             250             250             250           1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In the main study phase, physician (n=1440) and consumer (n=1,500) 
participants will be randomly assigned to view one of three possible 
versions of a DTC or professional ad for a fictitious prescription drug 
for diabetic neuropathy and will be asked to complete an online survey 
to assess their perceptions and understanding of product safety and 
efficacy, perceptions and understanding of the additional contextual 
information, perceptions of comparative safety and efficacy, 
perceptions of the comparator product, and intention to seek more 
information about the product (see Exhibit 2). This sample size will 
provide us with sufficient power to detect small-to-medium sized 
effects.
    In addition to the Price Comparison and Price Comparison + 
Additional Context ads used in pretesting, a third ad version will have 
a claim about the price of the product but will not present information 
about the price relative to a competitor, and will act as a control.

                                          Exhibit 2--Main Study Design
----------------------------------------------------------------------------------------------------------------
                                            Type of price comparison
-----------------------------------------------------------------------------------------------------------------
                                                                                       Price
                                                                       Price        information
                     Sample                            Price       comparison +      only (no          Total
                                                    comparison      additional      comparison/
                                                                      context        control)
----------------------------------------------------------------------------------------------------------------
Consumers (DTC ad)..............................             500             500             500           1,500
Physicians (Professional ad)....................             480             480             480           1,440
                                                 ---------------------------------------------------------------
    Total.......................................             980             980             980           2,940
----------------------------------------------------------------------------------------------------------------

    Participants will be consumers who self-identify as having been 
diagnosed with diabetes and physicians who are General Practitioners 
(e.g., Family Practice, General Practice, Internal Medicine) and 
Specialists (e.g., Endocrinology, Pain Management). All participants 
will be 18 years of age or older. We will exclude individuals from the 
consumer sample who work in healthcare, pharmaceutical, 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.
    In the Federal Register of May 7, 2014 (79 FR 26255), FDA published 
a 60-day notice requesting public comment on the proposed collection of 
information. Two submissions were received; one from Ms. Lenisse 
Lippert of Quality Matrix Solutions, and one from AbbVie 
biopharmaceutical company, which contained multiple comments. We 
summarize and respond to these comments below.
    (Comment 1 from Lenisse Lippert, Quality Matrix Solutions) ``I 
would like to participate in the industry feedback on a proposed study 
to better understand direct-to-consumer advertisements that compare 
drug pricing, and how that information affects a consumer's perception 
of a drug's overall safety and efficacy versus the comparator 
product.''
    (Response) We thank Ms. Lippert for her comment.
    (Comment 2 from AbbVie) To prevent fatigue, online market research 
surveys do not generally exceed 20 minutes. Given that FDA is trying to 
make the most of their survey opportunity by asking many questions, it 
would be wise to place the meatier pricing related questions earlier in 
the survey when respondents are still engaged.
    (Response) We take the survey length very seriously. We are 
sensitive to issues regarding respondent fatigue and its impact upon 
completion rates and thus have placed items that are most likely to be 
influenced by respondent fatigue (open-ended questions) at the 
beginning of the survey. We have employed similar online surveys on

[[Page 18409]]

several previous studies, and we have obtained high completion rates, 
typically 90 percent or higher. For example, on a recent study 
(Experimental Study: Examination of Corrective Direct-to-Consumer 
Television Advertising [OMB control number 0910-0737]), we had a pool 
of 1,071 eligible respondents, and only 14 of those respondents failed 
to complete the survey. We anticipate that the completion rate for this 
study will be similar.
    (Comment 3 from AbbVie) In both surveys, respondents are asked many 
questions about product X that appear positively stated. Therefore, 
there is a risk of a bias by asking the critical pricing and language 
questions after the respondent has already been exposed to many product 
X questions and supposed attributes. To avoid bias, the most critical 
questions should appear as up front in the surveys as possible.
    (Response) Of greatest interest to FDA is the question of whether 
presence or absence of price comparison information and contextual 
information influences outcomes such as perceptions of comparative 
safety and efficacy, perceptions of the comparator product, and 
intentions to seek more information about the advertised product. 
Placing pricing related questions near the beginning of the survey 
would likely bias participants to think about pricing information more 
than they would under natural conditions, which may influence their 
responses to the aforementioned critical dependent variables. Although 
current question ordering may bias responses to pricing related 
questions, we believe this outcome is less consequential than the 
reverse, as suggested in this comment. Consequently, we intend to 
retain the current order of questions in the survey.
    (Comment 4 from AbbVie) It is unclear if the drug examples (X and 
Y) are real world medicines that could be taken by the patient 
respondents. If so, do respondents need to be aware of each product? If 
they need not be aware, you will need to balance the samples for any 
differences between cells. In addition, the cells will also need to be 
balanced for current drug usage to prevent additional bias.
    (Response) We have constructed a fictional product for use in this 
study to control for effects that might result as a consequence of 
having taken the product in the past. The comparator is a real product. 
We will measure participants' experience with medication for this 
condition, prior exposure to advertising for the comparator, and prior 
experience taking the comparator. Responses to these questions can be 
used as covariates in analysis.
    (Comment 5 from AbbVie) The questions on the physician survey 
should be at a higher level language versus the general population. We 
note the questions in the patient questionnaire seem to vary in reading 
level required to comprehend them. We recommend that FDA review the 
questions for consistency so as not [to] introduce a reading bias.
    (Response) We appreciate this comment. We have conducted cognitive 
interviews (OMB control number 0910-0695) to refine and improve the 
survey questions. We will also be conducting two rounds of pretesting 
which will provide an additional opportunity to identify and remove 
questions that do not function as intended, further refining the 
questionnaire prior to the main study. These activities include 
consideration of language level and whether it is appropriate for the 
participants being surveyed.
    (Comment 6 from AbbVie) We recommend this ad explicitly present 
contextual information that the two drugs may not be comparable in 
terms of efficacy and safety (i.e., the products are not 
interchangeable) notwithstanding price comparisons. This would permit 
FDA to assess whether it has provided enough contextual information so 
that the audience understands that the products are not 
interchangeable. Consequently, there would be a response choice in the 
questionnaire that allows a respondent to acknowledge the products are 
not interchangeable. AbbVie suggests that an option be added that 
reads, ``The brochure left the impression that Drug X's efficacy (and 
safety) should not be compared to Drug Y's; the products are not 
interchangeable.''
    (Response) The context language is based on feedback from the 
cognitive interviews. We appreciate the comment and have added a 
question to assess participants' attitudes about the context with 
regard to interchangeability of the products being compared.
    (Comment 7 from AbbVie) It is not clear what type of cost 
information is being presented in these ads. We suggest that the 
advertisement should make clear what costs are being presented, for 
what doses, and over what time frames so that readers are comparing 
`apples to apples' when viewing the ads. If study budget allows, it 
would be ideal to test a variety of cost information.
    (Response) The price comparison is for the same indication on a 
yearly basis. We agree that it would be informative to expand the study 
to test a variety of cost information but do not have the resources to 
do so.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                    Activity                        Number of     responses per   Total annual         Average burden per response          Total hours
                                                   respondents     respondent      respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample outgo (pretests and main survey)........          41,110  ..............  ..............  .......................................  ..............
Screener completes.............................           7,400               1           7,400  0.03 (2 minutes).......................             222
Eligible.......................................           4,933  ..............  ..............  .......................................  ..............
Completes, Pretests Phase 1....................             400               1             400  0.5 (30 minutes).......................             200
Completes, Pretest Phase 2.....................           1,000               1           1,000  0.5 (30 minutes).......................             500
Completes, Main Study..........................           2,940               1           2,940  0.5 (30 minutes).......................           1,470
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................           2,392
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 18410]]

    Dated: March 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07818 Filed 4-3-15; 8:45 am]
BILLING CODE 4164-01-P