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