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

 
Docket ID: FDA-2009-N-0582
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
The Food and Drug Administration (FDA) is amending its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Advertisements broadcast through media must disclose the product's major risks in what is sometimes called the "major statement." The rule implements provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) by requiring that the major statement in DTC television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug be presented in a clear, conspicuous, and neutral manner. FDA is also implementing, as directed by FDAAA, standards that would be considered in determining whether the major statement in these advertisements is presented in the manner required by FDAAA.
RIN: 0910-AG27
Impacts and Effects: None
CFR Citation: 21 CFR 202.1
Priority: Other Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Spring 2011
Agenda Stage of Rulemaking: Long-term Action
Major Rule: No
Legal Authorities: 21 USC 321, 21 USC 331, 21 USC 352, 21 USC 355, 21 USC 360b, 21 USC 371, ...
Legal Deadlines: None
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: No
Small Entities Affected: No
International Impacts: No
Energy Effects: No
Included in Regulatory Plan: No
Timetable
ActionDateFR Citation
Final Action00/00/0000
NPRM03/29/201075 FR 15376
NPRM Comment Period End06/28/2010
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner
Keyword(s): cder, cder20096, television and radio, conspicuous, neutral manner, dtc, advertisements
Type: Rulemaking
Docket Status: OPEN
Center: CDER
Docket Item Code: N
 

Primary Documents

View All  (4)
Comment Period Closed
Apr 09, 2012 11:59 PM ET
Proposed Rule
Posted: 03/23/2012
ID: FDA-2009-N-0582-0055
Comment Period Closed
Feb 27, 2012 11:59 PM ET
Proposed Rule
Posted: 01/27/2012
ID: FDA-2009-N-0582-0040
Comment Period Closed
Jun 28, 2010 11:59 PM ET
Proposed Rule
Posted: 03/29/2010
ID: FDA-2009-N-0582-0001
Comment Period Closed
Other
Posted: 04/27/2010
ID: FDA-2009-N-0582-0017

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 03/29/2010
ID: FDA-2009-N-0582-0011
Comments Not Accepted
Supporting & Related Material
Posted: 03/29/2010
ID: FDA-2009-N-0582-0003
Comments Not Accepted
Supporting & Related Material
Posted: 03/29/2010
ID: FDA-2009-N-0582-0012

Comments

View All  (44)

74
Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Long Term Action
Current Stage
Agency Contact
Audrey A. Thomas
Regulatory Policy Analyst
FDA/HHS
audrey.thomas@fda.hhs.gov
301 796-3601
301 847-8440 (Fax)
Center for Drug Evaluation and Research WO 51, Room 6364 10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.