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DTC Insights' Alert:FDA Cancels Pre-Review Program

In a Federal Register filing on Wednesday, the FDA announced that it was canceling the ad-review program for broadcast DTC that was outlined in the FDA Amendments Act (FDAAA).

January 17, 2008

FDA Cancels Pre-Review Program
For Television DTC Advertising

In a Federal Register filing on Wednesday, the FDA announced that it was canceling the ad-review program for broadcast DTC that was outlined in the FDA Amendments Act (FDAAA). The program (with a user-fee format) was deemed worthy by many pharma marketers, with 31 companies or "entities" committing to submit 151 TV ads for pre-review in this the first year. The fee per review had been set at $41,390 per ad.

With the cancellation, the FDA said it will continue to review ads that are submitted in "as timely a manner as resources permit." However, as stated in the FDAAA, companies are required to submit TV ads for review 45 days prior to dissemination, according to Jim Davidson , a Washington-based attorney and founder of the public policy law firm Davidson & Co. It's not clear how FDA/DDMAC intend to manage review of these ads, given the cancellation of the user-fee program, he noted. In its filing, the FDA noted that "no invoices will be sent" to pharma companies that had agreed to participate in the program.

In the filing, the FDA said the television ad-review program was being scrapped "because the necessary user-fees for the program were not provided in advance in appropriations Acts," as required by FDAAA. So while the president signed a bill that outlined this new review program - and the FDA and pharma companies agreed to it - the program cannot get off the ground because a separate piece of legislation dealing with appropriations to government agencies did not contain the requisite language.

A key part of the program would have been the hiring of 27 additional DTC reviewers so the agency could commit to reviewing submitted ads within 45 days on at least 50% of the submissions.

" Congress and the FDA need to work out their differences and not leave the industry hanging," Davidson told DTC Insights .

The issue came down to some members of the House who opposed the idea that pharmaceutical companies would be paying to have their ads reviewed - despite the fact that there's already a similar program in place for reviewing new-drug applications - because it would raise questions about objectivity. Those members were able to keep wording that would have enabled the review program out of the omnibus appropriations bill signed by President Bush in late December.

MORE INFORMATION: The link to the Federal Register filing is: http://a257.g.akamaitech.net/7/257/2422/01jan20081800/
edocket.access.gpo.gov/2008/E8-740.htm

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