New DTC Ad Guidance Needed To Eliminate Ambiguity, Ex-FDAer Pitts Says
This article was originally published in The Pink Sheet Daily
A new direct-to-consumer advertising guidance is needed to eliminate regulatory ambiguity, former Associate Commissioner for External Relations Peter Pitts said
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“We’re not pleased with the way direct-to-consumer advertising is going,” Acting Commissioner Crawford says. DTC ads have become “ridiculous,” he says; “very strong measures” by FDA may be warranted.
In the first of three studies, FDA will examine consumer responses to a mock weight-loss drug ad to determine how and why consumers use the brief summary. Research data will be collected in the spring, but a final guidance on the brief summary content and format “will be awhile,” FDA says.
The agency pledges further review of its guidance on direct-to-consumer advertising. Broadcast ads for drugs and enforcement actions against repeat offenders could see more attention.