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HHS/FDA RIN: 0910-AG27 Publication ID: Fall 2010 
Title: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 202.1   
Legal Authority: 21 USC 321    21 USC 331    21 USC 352    21 USC 355    21 USC 360b    21 USC 371    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/29/2010  75 FR 15376   
NPRM Comment Period End  06/28/2010    
Final Action  10/00/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Audrey A. Thomas
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6364, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: audrey.thomas@fda.hhs.gov