FDA CONSIDERING USER FEES TO COVER DTC ADVERTISING REVIEWS
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.
Upcoming Events
-
21Oct