DTC Held Hostage? FDA Pre-Review of TV Ads May Delay Rx Campaigns
This article was originally published in RPM Report
FDA is proposing changes to its regulation of television advertising for prescription drugs with a mandatory pre-review of ads for certain products. The agency says it has the resources to complete all reviews on time. But stakeholders worry that the draft requirements would delay campaigns and make DTC advertising more expensive. It’s not like there’s a good alternative: jumping the gun on DTC carries its own set of risks.
You may also be interested in...
The agency’s draft guidance on prereview of television advertisements also requires companies to submit the information they rely on to support claims in an ad.
FDA has oversight over DTC advertising for Bayer’s Yaz contraceptive after the company violated an earlier agreement with state attorneys general.
The good news for advertisers: FDA will have more resources for pre-review of ads in 2008, funded by the taxpayers. The bad news: what happens in 2009?