FDA Scuttles Fees To Review TV Ads
3 CommentsBy Ed Silverman // January 17th, 2008 // 2:06 pm
Why? Congress failed to appropriate the funds due to haggling over language in the appropriations bill, which was required by the recently enacted FDA Amendments Act. As a result, the FDA has canceled the paid program to review TV ads, which 31 drugmakers had signed up for at a cost of $41,390 per review. (Here’s the Federal Register notice).
How did the FDA arrive at this figure? The revenue to be generated by review fees was $6.25 million, which was divided by 151, the number of TV ads that companies indicated previously they would submit for review. A drugmaker was must also pay a one-time operating reserve fee, which is based on the number of submissions in its first year in the program. To watch for violations, distortions and oversights, the FDA planned to add 27 employees.
Despite the change, the FDA maintains ads will still be reviewed in “as timely a manner as resources permit.” In other words, not very often.
Hat tip to FDA Law blog and DTC Perspectives
ol cranky
I have an idea, let’s just get rid of DTC advertising for medications a patient can’t purchase without a prescription.
Mark
For more information on this development, check out the DTC Insights Alert on the DTC Perspectives home page.
Mark
Atlex
Ed, I may be misreading what you are stating. As I understand it, the FDA is not scuttling the program to review ads. It plans to continue that effort. However, the agency is not allowed to charge user fees for this purpose since the appropriators left the agency with no mechanism to accept these particular fees. I’m not sure, but I thought I read elsewhere that the FDA received an appropriation of $6.25M directly from the federal budget to cover this initiative.