Another user fee for the US drug agency could help pay for research of off-label uses, but lack of resources could be a regulatory problem.

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.

FDA is interpreting the new "neutral' standard for direct-to-consumer ads to mean "unbiased." Experts in FDA ad regulation policy are now debating what an advertiser has to do to be unbiased: does it just mean keeping down distractions during the statement of risk information? Or does it mean making an effort not to over-warn?