By Lisa Seachrist

Washington Editor

WASHINGTON — Industry and FDA negotiators have made significant progress toward finalizing the details for the reauthorization of the Prescription Drug User Fee Act (PDUFA) of 1992, which expires in September 1997.

Provisions agreed to in PDUFA II may provide an unprecedented amount of responsiveness from the agency to sponsors’ concerns. The negotiators have agreed to increased responsiveness to clinical hold inquiries as well as to written protocol agreements. The exact increase in user fees is still under discussion.

“We are in a real progress zone with PDUFA,“ said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). “And we intend to make the very most of it.“

The agency is under pressure to come to an agree ment over the user fees before the year’s end because they must submit their projected budget to the Office of Management and Budget in early January. As a result, money issues are on a fast track and the negotiators are trying to reach an agreement by Friday. However, the discussions will likely continue into this week.

PDUFA was originally designed to allow the agency to shorten review times by hiring more review staff with the fees charged to industry. As such, PDUFA was tremendously effective. BIO is using the current negotiations to make the act even more beneficial to the biotech industry.

Perhaps the most significant advance for the industry is the agency’s willingness to enter into written protocol agreements. This provision allows the drug sponsor and the agency to agree to a clinical protocol that will satisfy the agency’s requirements for safety and efficacy. Once both parties have entered into that agreement, the agency agrees to stick to that protocol unless there was a public health risk that was unrecognized at the time of the agreement.

In addition to the written protocol agreement, performance goals pertaining to those agreements are beginning to be set. Feldbaum noted that the industry would like to see 60 percent of all protocols finalized within 45 days during the first year. “We are heading toward significant performance goals,“ said Feldbaum.

The industry is adamant that the money generated by the user fees go to review drugs and is concerned that it will instead fund FDA activities that budget appropriations fail to cover. Feldbaum said the industry has identified FDA-sponsored research which doesn’t directly relate to drug development or safety issues and that these programs should be cut rather than supported by user fees.

While many of the major provisions in PDUFA have been settled, the negotiators have placed several issues on a slower track. Discussions over issues about manufacturing regulations as well as an expedited approval process for breakthrough products proposed by BIO will have to wait for the New Year and are scheduled to be completed by Feb. 1.

The final version of PDUFA, however, won’t be determined by the agency and industry negotiators. Once the terms are agreed upon, they will be presented to Congress, which must enact the legislation.

“Once this hits the pit and goes into Congress, we have to understand that things can happen and they could get a little messy,“ Feldbaum said. “But, I think we will have a much smoother process with the 105th Congress than we had with the 104th.“

Even with all the progress on PDUFA, Feldbaum maintained that it doesn’t obviate the need for FDA reform. “Certainly, we can’t have an FDA reform bill until we know what PDUFA achieves,“ Feldbaum said. “But PDUFA isn’t likely to address the whole of FDA reform.“