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HHS/FDA RIN: 0910-AG27 Publication ID: Fall 2019 
Title: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, Neutral Manner 

The Food and Drug Administration (FDA) is amending its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Prescription drug advertisements presented through media such as TV and radio directly to consumers must disclose the product’s major risks in what is sometimes called the major statement. The rule would require 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. This rule establishes standards that would be considered in determining whether the major statement in these advertisements is presented in the manner required.

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 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 202.1   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 352    21 U.S.C. 355    21 U.S.C. 360b    21 U.S.C. 371    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/29/2010  75 FR 15376   
NPRM Comment Period End  06/28/2010    
NPRM Comment Period Reopened  01/27/2012  77 FR 4273   
NPRM Comment Period End  02/27/2012 
NPRM Comment Period Reopened  03/29/2012  77 FR 16973   
NPRM Comment Period End  04/09/2012 
Final Rule  06/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Local, State 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Catherine Gray
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 51, Room 3368,
Silver Spring, MD 20993
Phone:301 796-0590
Fax:301 847-8440