FDA Reform Debated

FDA Reform Debated

House Commerce Health and Environment Subcommittee members Wednesday split along party lines on whether reauthorization of the Prescription Drug User Fee Act should be linked with FDA reform. Republicans advocated addressing the two simultaneously but Democrats urged that PDUFA and broader FDA legislation be handled separately.

Enacted in 1992 and set to expire Sept. 30, 1997, PDUFA levies fees on prescription drug companies to help offset the costs of the drug approval process.

The additional revenues generated by PDUFA have been credited with helping FDA approve new drugs in record time. Last year, for example, FDA approved 53 "new molecular entity" medicines, nearly twice as many as the previous year.

Republicans, including Subcommittee Chairman Michael Bilirakis of Florida, advocated advancing unified legislation that combines broader FDA reform and PDUFA reauthorization.

Rep. Fred Upton, R-Mich., said Congress would be doing only "half the job" if it reauthorized PDUFA without changing the broader framework of the FDA, which oversees $1 trillion worth of products.

But subcommittee ranking member Sherrod Brown, D-Ohio, said potential disagreements over the breadth and substance of FDA reform could doom PDUFA.

"Let's agree today not to let disputes about FDA reform stand in the way" of PDUFA reauthorization, Brown said. If FDA reform and PDUFA legislation are combined, he said, reform should be limited to "things we can agree on."

FDA official William Schultz also supported moving FDA reform and PDUFA legislation separately. However, if the two are linked, he said, Congress "should be very careful not to drag PDUFA reauthorization down."

Although the two sides disagreed about how to go about reauthorizing PDUFA, they concurred that the administration's plan to impose new user fees on other products is dead.

Both majority and minority members warned the FDA against anticipating additional revenues from new and expanded user fees to supplement the agency's FY98 budget. The Clinton administration's FDA budget proposal includes a host of new user fees that Bilirakis said have been "recycled so often by four different administrations that no one takes them seriously."

Brown also assailed the new user fees, calling them "unrealistic and unfair to regulated industries."

Bilirakis asked acting Commissioner Michael Friedman to explain how the FDA would deal with a proposed $68 million cut in FY98 budget authority and still fulfill its mission.

Friedman conceded the proposed budget cuts, if approved, will prevent the FDA from "discharging its full range of activities and will not allow us to do them in as timely a manner as we think appropriate."

While the FDA has "no specific plans" as to how it would sustain such a reduction, Friedman said, the agency would work with Congress to determine the best course of action.

FDA official Robert Byrd said that deciding "which programs have to suffer and be reduced" would be determined with advice from industry and Congress.

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