Docs Blast FDA's PDUFA Proposal

A coalition of nearly two dozen leading physicians and scientists have called on Congress to scrap the Food and Drug Administration's proposal for reauthorizing the Prescription Drug User Fee Act (PDUFA) and move to general tax revenues to support the agency.

The legislation is the subject a hearing this morning in the Senate Health Education Labor and Pensions Committee, chaired by Sen. Ted Kennedy.

The letter submitted to the committee this morning said PDUFA has limited the FDA's ability to monitor drug safety. The agency's proposal, negotiated behind closed doors with the drug industry, "does not come close" to meeting the standards outlined in an Institute of Medicine report last year.

That report called the FDA a broken agency whose culture needed a thorough overhaul. "PDUFA has helped to foster the public’s perception that industry has become the primary client of FDA rather than the American people," the letter said.

Signatories included two former high-ranking FDA staffers, two former editors of the New England Journal of Medicine, and one of the co-chairs of the IOM report. The effort was organized by Susan Wood, the former head of the Office of Women's Health at FDA and now a professor at George Washington University, and the Project on Scientific Knowledge and Public Policy.

The letter called on Congress to replace the $300 million collected in user fees with a direct appropriation, which "is the most effective way to ensure FDA’s independence and commitment to drug safety."

If Congress pleads poverty and insists on reauthorizing PDUFA, the letter said the legislation should:

• Allow FDA leadership to determine how the agency allocates the fees collected to fulfill all aspects of its mission.

• Deadlines or targets for speed of review must be eliminated or modified to allow flexibility and adequate time for evaluation and analysis by reviewers.

• New performance goals must be linked with safety or other public health outcomes, not just speedy approval decisions.

• Adequate resources must be made available for scientific research and training for FDA scientific and medical staff, including in drug safety epidemiology and risk management.

PDUFA's authorization expires at the end of September. Some observers believe Kennedy is seeking to sweep PDUFA reauthorization, an FDA reform bill and his generics biologics bill into a single omnibus package that will protect both the agency and the industry from serious reform.

Posted by gooznews at March 14, 2007 09:22 AM