[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9217-9219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03390]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Disclosure Regarding Additional Risks in Direct-to-
Consumer Prescription Drug Television Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on research entitled ``Disclosure Regarding 
Additional Risks in Direct-to-Consumer (DTC) Prescription Drug 
Television (TV) Advertisements (Ads).'' This study will investigate the 
impact of limiting the risks presented in DTC prescription drug 
television ads to those that are serious and actionable, and including 
a disclosure to alert consumers that there are other product risks not 
disclosed in the ad.

DATES: Submit either electronic or written comments on the collection 
of information by April 21, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

[[Page 9218]]


FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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.
    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 
noncompliance 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 [drug name] before starting it.'' The Office of 
Prescription Drug Promotion (or we) plans to investigate the 
effectiveness of this ``limited risks plus disclosure'' strategy 
through empirical research.
    Our 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 below, 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. 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 an ad, as depicted in table 1 
below. 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 above. 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 G, 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. Preliminary 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.

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


[[Page 9219]]

    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 DTC      Number of     responses per   Total annual          Average burden per response          Total hours
           prescription drug TV ads               respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot study screener..........................            3300               1            3300  0.03 (2 minutes)........................              99
Main study screener...........................           10000               1          10,000  0.03 (2 minutes)........................             300
Pilot study...................................             500               1             500  1.......................................             500
Main study....................................            1500               1            1500  0.50 (30 minutes).......................             750
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................            1649
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03390 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P