Regulatory Counsel

0910-AG27 202310 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage Yes No 21 CFR 202.1 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 ... No 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 11/00/2023 Yes Businesses Governmental Jurisdictions Local State No No Yes No Suzanna Boyle Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-4723 suzanna.boyle@fda.hhs.gov 10903 New Hampshire Avenue, WO 51, Room 3214, Silver Spring MD 20993