0910-AG27 201104 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 Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner The Food and Drug Administration (FDA) is amending its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Advertisements broadcast through media must disclose the product's major risks in what is sometimes called the "major statement." The rule implements provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) by requiring 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, as directed by FDAAA, standards that would be considered in determining whether the major statement in these advertisements is presented in the manner required by FDAAA. Other Significant Previously Published in The Unified Agenda Long-Term Actions No No 21 CFR 202.1 21 USC 321 21 USC 331 21 USC 352 21 USC 355 21 USC 360b 21 USC 371 ... No NPRM 03/29/2010 75 FR 15376 NPRM Comment Period End 06/28/2010 Final Action To Be Determined No None No No No Audrey Thomas A. 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 audrey.thomas@fda.hhs.gov Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6364, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002