Moving toward mandatory review of direct-to-consumer advertising, the FDA has released draft rules for which sorts of materials need review--and in which form they can be submitted. The agency guidance affirms the current practice of focusing on ads for new drugs or new indications on old drugs, ads for drugs that fall under risk-management plans, plus ads that make their debut after a significant label change.
But the new rules change the format for ad review. Companies can submit their review applications with storyboards depicting the proposed ad, but once the "final recorded version of the ad" has been produced, it has to be submitted "for pre-dissemination review."
As the Pharma Marketing Blog notes, however, if the FDA doesn't meet its 45-day deadline for rejecting or accepting an ad, then the company can opt to go ahead and air it. "There is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA's comments," the agency notes in its guidelines. "However ... the sponsor is at risk of enforcement action" if the ad violates FDA rules.
- see the item at Regulatory Focus
- get Pharma Marketing Blog's analysis
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