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HHS/FDA RIN: 0910-AG27 Publication ID: Spring 2023 
Title: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format  

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 must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. The rule would revise the regulation to reflect the statutory requirement that in DTC advertisements for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications of the advertised drug must be presented in a clear, conspicuous, and neutral manner. This rule also establishes standards for 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 
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 Reopened End  04/09/2012 
Final Rule  07/00/2023 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses, Governmental Jurisdictions  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Suzanna Boyle
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 51, Room 3214,
Silver Spring, MD 20993
Phone:240 402-4723