FDAnews Drug Daily Bulletin


Nov. 17, 2005

The FDA, in a controversial move, is considering increasing drug user fees to pay for activities not directly related to product application reviews, including the cost of reviewing direct-to-consumer (DTC) advertisements.

The FDA argues in a recently released white paper, "Prescription Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications," that it may seek an increase in user fees under the latest PDUFA reauthorization to cover the additional costs the agency will face in reviewing drug advertisements. PDUFA is set to expire in September 2007.

But the agency admits these reviews are not covered under PDUFA and therefore the agency does not have authority to raise the rates to cover ad reviews. "This review is not part of the PDUFA 'process for the review of human drugs,'" the report says.

However, the FDA argues that the issue is closely related and should be covered by PDUFA fees, arguing that these reviews are linked "to fundamental aspects of new drug review." The agency also maintains that these reviews will be a "mushrooming review workload" that needs to be funded.

According to the report, without increasing fees the agency would lack the funds to do a timely review of DTC ads to ensure they meet labeling requirements and provide a fair balance of information on benefits and risks. These delays could discourage companies from submitting the ads for prior agency review, the paper adds. "Current FDA resourcing for this work would probably result in delayed reviews if all companies were to submit their ads. Such delays would likely affect companies' ability to meet their marketing timelines, and discourage them from submitting materials for prior FDA review," the report says.

But industry officials have already criticized the agency for its efforts to increase fees for activities not directly covered by PDUFA. During a recent public hearing to discuss PDUFA reauthorization, PhRMA officials were skeptical about the agency's call for fee increases to cover non-application-related meetings, arguing that the move may represent an unauthorized tax.

To view the white paper, go to http://www.fda.gov/oc/pdufa/PDUFAWhitePaper.pdf.