DTC Pre-review Requirement Broadly Defined Under FDA Draft Guidance

The agency’s draft guidance on prereview of television advertisements also requires companies to submit the information they rely on to support claims in an ad.

Drug sponsors will have to submit essentially every direct-to-consumer television ad to FDA for review prior to dissemination under the agency’s just-released draft guidance. And in a new twist, sponsors will also have to submit information they rely on to support claims made in an ad.

FDA released the draft guidance, “Direct-to Consumer Television Advertisements – FDAAA DTC Television Ad Pre-Dissemination Review Program,” on...