DTC user fee plan canned
After all that, Congress has canceled the user fee program for DTC TV ad reviews.
In the Jan. 16 Federal Register, FDA advised that the DTC TV advertisement user fee program “will not commence because the necessary user fees for the program were not ‘provided in advance in appropriations Acts' as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), and the previously issued notice establishing user fee rates for the program for fiscal year 2008 is being withdrawn.”
The FDAAA, signed into law in September, authorized a new user fee program for advisory review of DTC TV ads that would have allowed companies to voluntarily submit TV ads for fast-track review before they aired.
However, an appropriations bill Bush signed at the end of the year does not appropriate funds for reviews. “As a result.…FDA does not have the authority to collect and spend user fees for this purpose,” the Federal 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, per ad.The user fee program was opposed by some in Congress who felt that it would bring undue industry influence on agency reviewers.