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HHS/FDA RIN: 0910-AG27 Publication ID: Spring 2018 
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 broadcast 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. FDA is also implementing 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: Long-Term Actions 
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    
Final Rule  07/00/2019 
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