By Lisa Seachrist

Washington Editor

WASHINGTON — The House Thursday began its efforts at FDA reform and reauthorization of the Prescription Drug User Fee Act (PDUFA) with FDA and industry representatives testifying before the House Subcommittee on Health and Environment.

While noting that the FDA has made significant strides in approval times over the past five years, chair Michael Bilirakis (R-Fla.), like Sen. Jim Jeffords (R-Vt.), intends to use the pending expiration of PDUFA at the end of September to drive a myriad of reforms at the agency. Jeffords, who is chairman of the Senate Labor and Human Resources Committee, is steering FDA reform for the Senate.

"It is now wishful thinking for the agency or the industry to believe that the successes of the original user fee bill can be accomplished in reauthorized user fee legislation," Bilirakis said in his opening remarks. "This is why it is critical to move a unified bill which has both substantive legislative reforms and PDUFA."

The subcommittee focused on shrinking drug development time, reauthorizing PDUFA — the legislation that assesses user fees to the industry in return for faster drug reviews — and funding issues with members agreeing that the Clinton Administration's fiscal year 1998 plan to rely on as-yet-unapproved user fees to supplement an 8 percent drop in appropriations is untenable.

"We are working for the modernization of FDA and the reauthorization of PDUFA," said Richard Burr (R-NC). "It is not a very good start when the president proposes a $68 million cut in the agency's appropriations."

The administration's budget calls for already-established user fees and new user fees for a variety of industries to supplement the cut in appropriations. As several subcommittee members pointed out, the past four administrations have proposed such user fees and Congress has never agreed to them. The 105th Congress has bipartisan opposition to the fees and is unlikely to support the administration's budget.

"I blanketly oppose any budget that relies on user fees," said Henry Waxman (D-Calif.). "I think the administration is wrong on this."

Michael Friedman, lead deputy commissioner at the agency, testified that the appropriations cut will come entirely out of FDA personnel, which could result in the firing of 1,120 employees should the budget remain the same and user fees not be enacted.

Burr pressed Friedman on whether the agency could adequately meet its obligations set for in the reauthorized PDUFA if the personnel cuts took place. Friedman replied, "No."

Gordon Binder, chairman and CEO at Amgen Inc., testifying for both BIO and the Pharmaceutical Research and Manufacturers of America (PhRMA), noted, "Our industry will invest $19 billion in research in 1997 and the National Institutes of Health will invest $13 billion. It's absolute absurdity to allow a $68 million budget savings to slow down $32 billion in research activities."

Binder also testified to the improvements negotiated between the agency and industry in PDUFA II. Binder repeated the four bedrock principles on which PDUFA is based: it represents a long-term commitment by Congress, requires that the fees be additive to the FDA's baseline appropriations, dedicates the fees to the drug review process and provides quantifiable performance standards.

"The reforms agreed to in PDUFA II will result in a decrease in drug development time of 10-16 months," Binder said.

The FDA and industry have agreed to a proposal that includes a 21 percent increase in user fees as well as timelines for setting key meetings, a 30-day response deadline for the agency to answer sponsor's inquiries, and written protocol agreements.

"We have agreed on every single point in the PDUFA reauthorization plan," Binder said. "And our agency is prepared to pay 28 percent more in user fees in order to get more people involved in the process. But we have to have the baseline appropriation."

Several subcommittee members questioned Binder and David Holveck, president and CEO of Centocor Inc., about whether the agency engaged in collegial communication with the regulated industries. Both agreed that the FDA has become more communicative, but Binder pointed out, "There is always room for improvement."

While most members agree that PDUFA should be reauthorized quickly, they disagree on whether to link more global reforms to its reauthorization.

"It's a no-brainer for the reauthorization of PDUFA before it sunsets [sic] in September," Frank Pallone Jr. (D-NJ) said. "I would prefer an outright reauthorization. PDUFA is going to expire in five months and I am concerned that it will be held hostage to other reforms."

Joe Barton (R-Texas) said the FDA had misused PDUFA funds and that he is "unwilling to reauthorize PDUFA at all."

Barton maintained that his staff on the House Oversight Committee had unearthed evidence of misappropriation of PDUFA funds and that he was considering conducting hearings into the matter. However, when pressed by ranking member Sherrod Brown (D-Ohio) to provide the information to the committee, he noted that the information was purely preliminary and said, "We don't have proof." *