FDA Reopens Comment Period on DTC Advertising Regulations

The US Food and Drug Administration (FDA) announced this week it is reopening a comment period on a proposed rule on presenting major statements in director-to-consumer (DTC) advertisements, extending comments for an additional 15 days.

The 23 March Federal Register notice follows an initial posting on 27 January, entitled Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements, which Regulatory Focus reported on at the time.

That study was in response to a proposed rule, Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner, which seeks to amend regulations concerning DTC advertisements for prescription drug products such that all DTC advertising would have to present their major statements-statements relating to the safety, side effects and contraindications of a product-in a "clear, conspicuous and neutral manner."

FDA is now allowing an additional 15 days of public commentary to inform their decision making on this proposed rule.

Read more:

Federal Register - Direct-to-Consumer Prescription Drug Advertisements: Presentation of Major Statement in Television and Radio Advertisements, etc.

Regulatory Focus - FDA Releases Study on Major Statements in DTC Advertising, Reopens Comment Period on Proposed DTC Regulation

See all Regulatory Focus articles on DTC Marketing