By Lisa Seachrist

Washington Editor

WASHINGTON -- FDA and industry representatives began negotiations late Friday afternoon to draft a new bill that would encompass both user fee reform as well as the whole of FDA reform. The negotiators intend to update Congress on their progress in 60 days.

At the behest of FDA officials, representatives from the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) met with the agency team which included members from the FDA's Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. The $100 million the agency receives from industry in the form of user fees will serve as the linchpin for the reform negotiations.

"Strategically, it is important that we are discussing the reauthorization of the Prescription Drug User Fee Act [PDUFA] in conjunction with broader FDA reform," said Carl Feldbaum, president of BIO. "It gives us enormous leverage when negotiating FDA reform."

FDA reform took center stage last year with both the House and Senate producing reform legislation. In the Senate, Nancy Kassebaum (R-Kan.) sponsored The FDA Performance and Accountability Act. Rep. Richard Burr (R-N.C.) sponsored The Drugs and Biologics Reform Act of 1996. Neither bill made it to the floor for a vote.

However, the proceedings around drafting the legislation featured contentious hearings lambasting FDA Commissioner David Kessler. And, both bills included provisions that precluded bipartisan support. Kassebaum's bill called for private drug reviews if the agency failed to review new drug applications in 180 days while the House permitted drug manufacturers to distribute information about off-label uses of the drug.

Despite failure to pass FDA reform legislation in the 104th Congress, industry and agency representatives began negotiations last fall for the reauthorization of the PDUFA which runs out in September. The industry used the negotiations to push for some reforms that failed to become legislation. At the end of the year, the FDA had agreed to institute written protocol agreements and to be more responsive to industry inquiries about clinical holds and protocol submissions.

On Friday, the agency proposed that those negotiations expand to include the whole of FDA reform. "It is just an acknowledgment that we have been able to get more accomplished as a result of working together rather than opposing one another," Feldbaum said. "The best atmosphere to affect change is cooperative and collegial."

The negotiators established six initial issues to resolve in 60 days: FDA's mission, a rewrite of law governing biologics that would codify changes encompassed in the reinventing government streamlining effort, access to unapproved therapies, manufacturing changes to streamline the supplemental application process and dissemination of scientific information.

Most of the issues come directly from the House and Senate bills produced in the 104th Congress. Feldbaum noted that it is important that the FDA has said that nothing is off the table.

"These talks are more than just good intentions," Feldbaum told BioWorld Today. "User fees will drive the whole process. And an industry-agency bill has a better chance for success."

Feldbaum noted that even though BIO has entered these negotiations with FDA, that doesn't preclude them from proceeding with reform efforts of their own.

PhRMA confirmed that the talks had begun but media officer Jeff Truett said that the organization would have no comment until the organization's board votes to accept the final bill. *

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