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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 | |
Abstract:
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. |
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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 |
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Timetable:
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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 Email: catherine.gray@fda.hhs.gov |