After all that, Congress has canceled the user fee programfor DTC TV ad reviews.
In the Jan. 16 Federal Register, FDA advised that the DTC TVadvertisement user fee program “will not commence because the necessary userfees for the program were not ‘provided in advance in appropriations Acts’ asrequired by the Food and Drug Administration Amendments Act of 2007 (FDAAA),and the previously issued notice establishing user fee rates for the programfor fiscal year 2008 is being withdrawn.”
The FDAAA, signed into law in September, authorized a new user fee program for advisoryreview of DTC TV ads that would have allowed companies to voluntarily submit TVads for fast-track review before they aired.
However, an appropriations bill Bush signed at the end ofthe year does not appropriate funds for reviews. “As a result.…FDA does nothave the authority to collect and spend user fees for this purpose,” theFederal Review notice stated. No funds, no program. Ads voluntarily submitted,the agency said, “will be reviewed in as timely a manner as resources permit,”and no invoices will be sent for them.
The agency had established a fee of $41,390 per review, perad.
The user fee program was opposed by some inCongress who felt that it would bring undue industry influence on agencyreviewers.
From the February 01, 2008 Issue of MM+M - Medical Marketing and Media
