Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner; Reopening of the Comment Period

Résumé

The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29,, to establish standards that would be considered in determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. In the Federal Register of January 27, 2012, FDA announced that it had added a document to the docket for the proposed rulemaking concerning a study entitled "Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements" (Distraction Study) and the public was given until February 27, 2012, to comment on this study as it relates to the proposed standards. FDA is reopening the comment period for the rulemaking proceeding in response to a request for more time to submit comments to the Agency.