Document ID: FDA-2009-N-0582-0055
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; Reopening of the Comment Period
Posted Date: 2012-03-23T04:00Z

[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Proposed Rules]
[Pages 16973-16974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6948]

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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; Reopening of the Comment Period

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,, 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. In the Federal Register of January 27, 2012, FDA 
announced that it had 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) and the public was given until 
February 27, 2012, to comment on this study as it relates to the 
proposed standards. FDA is reopening the comment period for the 
rulemaking proceeding in response to a request for more time to submit 
comments to the Agency.

DATES: Submit either electronic or written comments on the Distraction 
Study report as it relates to the proposed standards by April 9, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0582 and/or Regulatory Information Number (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 or 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, docket number, and RIN 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, 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., Bldg. 51, rm. 3276, Silver Spring, MD 20993-
0002, 301-796-3832.
    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

[[Page 16974]]

Federal Food, Drug, and Cosmetic Act (the FD&C Act), added by section 
901(d)(3)(A) of the Food and Drug Administration Amendments Act of 2007 
(Pub. L. 110-85) (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, and it provided a 90-day period for public comment, which 
closed on June 28, 2010.
    On January 27, 2012 (77 FR 4273), FDA reopened the comment period 
on this rulemaking until February 27, 2012, to allow an opportunity for 
interested parties to comment on FDA's analyses of the results of its 
study (see attachment in Docket No. FDA-2009-N-0582-0040) 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) as it relates to the 
proposed standards. The Pharmaceutical Research and Manufacturers of 
America (PhRMA) submitted a letter dated February 20, 2012, requesting 
an additional 15 days for interested persons to comment. FDA believes 
that an additional 15 days to comment on the Distraction Study as it 
relates to the proposed standards is appropriate.

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 
label them ``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: March 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6948 Filed 3-22-12; 8:45 am]
BILLING CODE 4160-01-P