FDA EXPECTS INCREASED FUNDING THROUGH PDUFA NEGOTIATIONS

The FDA believes its funding will increase in 2008 through negotiations over the Prescription Drug User Fee Act (PDUFA) but remains concerned that flat funding levels in 2007 will undermine a number of agency programs.

The FDA is facing "an extremely lean year" in 2007, John Jenkins, the director of the agency's Office of New Drug Review, told attendees of an Oct. 17 Regulatory Affairs Professionals Society conference. The flat funding levels the agency expects will not keep up with the rate of inflation, providing the FDA with insufficient funds to address its growing workload, he added.

While things look bleak in 2007, the agency believes it will receive an increase as part of the 2008 PDUFA reauthorization, Jenkins said. The discussions are almost complete and the agency has made a concerted effort to prove that it needs additional funding due to its increased responsibilities and greater expectations. For example, the agency is expected to do more postmarket assessment of drugs and has a larger role in counterterrorism and pandemic preparedness activities.

The FDA believes it has made its point, Jenkins said. The FDA has provided a "pretty compelling case" for an increase in PDUFA funding. The PDUFA proposal should be made public in the fall, he added.

PDUFA, under which industry pays fees to the agency to fund drug reviews, is due to expire in October 2007.

The drug review program needs more money to "keep it on solid financial footing." The FDA also needs additional staff, but believes this is unlikely in 2007. The agency's efforts to improve its IT infrastructure and fund epidemiological studies will also suffer from insufficient funding, Paul Seligman, the FDA's associate director of safety policy and communication, added.