The New Era in DTC: FDA Plans New Fees, Fines-and Creative Advice
This article was originally published in RPM Report
Executive Summary
The new FDA law marks a turning point in the relatively short history of direct-to-consumer broadcast ads. Sponsors have preserved the right to advertise, but will have to get used to following FDA's schedule-and taking FDA's advice.You may also be interested in...
DTC Held Hostage? FDA Pre-Review of TV Ads May Delay Rx Campaigns
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.
"Neutral" Is "Unbiased" In FDA' s Lexicon: Taking the Buzz and Distractions Out of Risk Statements
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?
"Neutral" Is "Unbiased" In FDA' s Lexicon: Taking the Buzz and Distractions Out of Risk Statements
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?
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