Document ID: FDA-2009-N-0582-0040
Agency: fda
Document Type: Proposed Rule
Title: Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner; Notice of Availability of Study Data
Posted Date: 2012-01-27T05:00Z

[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Proposed Rules]
[Pages 4273-4274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1672]

 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / 
Proposed Rules  

[[Page 4273]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 202

[Docket No. FDA-2009-N-0582]
RIN 0910-AG27

Direct-to-Consumer Prescription Drug Advertisements; Presentation 
of the Major Statement in Television and Radio Advertisements in a 
Clear, Conspicuous, and Neutral Manner; Notice of Availability of Study 
Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period on specific data.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period on specific data related to a proposed rule published in 
the Federal Register of March 29, 2010 (75 FR 15376), to establish 
standards that would be considered in determining whether the major 
statement in direct-to-consumer (DTC) television and radio 
advertisements relating to the side effects and contraindications of an 
advertised prescription drug intended for use by humans is presented in 
a clear, conspicuous, and neutral manner. FDA is announcing that it has 
added a document to the docket for the proposed rulemaking concerning a 
study entitled: ``Experimental Evaluation of the Impact of Distraction 
on Consumer Understanding of Risk and Benefit Information in Direct-to-
Consumer Prescription Drug Television Advertisements'' (Distraction 
Study). This study was designed to investigate some advertising factors 
that could influence consumers' understanding of a drug's risks. This 
document reopens the comment period for the rulemaking proceeding to 
allow an opportunity for comment on the study as it relates to the 
proposed standards.

DATES: Interested persons may submit either electronic or written 
comments on the Distraction Study report as it relates to the proposed 
standards by February 27, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0582 and/or RIN 0910-AG27, by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: (301) 827-6870.
     Mail/Hand delivery/Courier (For paper CD-ROM submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, FDA-2009-N-0582, and RIN 0910-AG27 for this rulemaking. All 
comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For 
additional information on submitting comments, see the ``Comments'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT:
For information concerning human drug products: Ernest S. Voyard, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Building 51, Suite 3200, Silver Spring, MD 
20993-0002, (301) 796-1200.
For information concerning human biological drug products: Stephen 
Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and 
Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 
20852-1448, (301) 827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 29, 2010 (75 FR 15376), FDA 
published a proposed rule entitled:``Direct-to-Consumer Prescription 
Drug Advertisements; Presentation of the Major Statement in Television 
and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner'' 
to amend its regulations concerning DTC advertisements of prescription 
drugs. Specifically, the proposed rule would implement a new 
requirement of the Federal Food, Drug, and Cosmetic Act, added by 
section 901(d)(3)(A) of the Food and Drug Administration Amendments Act 
of 2007 (FDAAA). This section requires that the major statement in DTC 
television or radio advertisements relating to the side effects and 
contraindications of an advertised prescription drug intended for use 
by humans be presented in a clear, conspicuous, and neutral manner, and 
directs FDA to publish regulations establishing the standards for 
determining whether a major statement meets these requirements. As 
directed by section 901(d)(3)(B) of FDAAA, the proposed rule described 
standards that the Agency would consider in determining whether the 
major statement is clear, conspicuous, and neutral. The proposed rule 
provided a 90-day period for public comment. The comment period closed 
June 28, 2010.
    In the proposed rule (75 FR 15376 at 15379), we noted that FDA had 
conducted a study on the impact of distraction on consumer 
understanding of risk and benefit information in DTC prescription drug 
television advertisements (72 FR 47051, August 22, 2007) (Distraction 
Study). We further stated that there would be an opportunity for public 
comment on FDA's analyses of the results of the Distraction Study. 
Therefore, FDA has added the Distraction Study report to the docket and 
is reopening the comment period to provide an opportunity for 
interested parties to comment on the results of the analyses as it 
relates to the proposed standards.
    The Distraction Study examined three factors which might influence 
people's understanding of the risk information in the audio portion of 
the advertisement: (1) The presence or absence of superimposed text, 
(2) the emotional (affective) tone of visual images, and (3) the 
consistency of the visual images

[[Page 4274]]

with the risk information. The results of the Distraction Study 
indicate that presenting risk information at the same time in text and 
in audio improves consumers' understanding of the risk information. The 
results of the Distraction Study did not find support for the idea that 
consumers' understanding of the risk information is influenced by the 
emotional (affective) tone of visual images or the consistency of the 
visual images with the risk information on the screen during the major 
statement.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
Distraction Study as it relates to the proposed standards. It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document and 
labeled ``ATTN: Distraction Study.'' The data and received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: January 20, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1672 Filed 1-26-12; 8:45 am]
BILLING CODE 4160-01-P