By Lisa Seachrist

Washington Editor

WASHINGTON — Embroiled in a bitter battle with the White House over Fast-Track Trade Authority, the House and Senate failed to finish the year's business and adjourn this weekend as they had planned. Nevertheless, both chambers of Congress found time enough to pass the conference report on FDA reform.

The legislation, which not only enacts reforms at the agency but reauthorizes the Prescription Drug and User Fee Act (PDUFA) for five more years, passed both chambers on a simple voice vote and now awaits President Clinton's signature.

"We are now calling on the president to act with all deliberate speed to sign this major legislation into law," said Carl Feldbaum, president of the Biotechnology Industry Organization. "This has been three years in the making. We really had to hold our breath to the very last minute."

The Republican majority leadership intended to finish up this year's legislative business Friday; however, with several major appropriations bills unsettled and the Fast-Track Trade Authority issue heating up, Congress stayed in session throughout the weekend with adjournment scheduled for Sunday.

Going into the weekend, the conference committee still had not produced a conference report on FDA reform. The staffs of the conferees had worked for the past two weeks, often in late-night sessions, to hammer out the differences between the House version, H.R. 1411, and the Senate version, S. 830.

The remaining issue at the beginning of the weekend had held the bill up in the Senate in September — establishing the scope of review for medical devices. Sen. Edward Kennedy (D-Mass.) and several patient organizations vehemently opposed the provision that would force the agency to review a medical device based solely on the use the manufacturer intended on the label.

Kennedy said the measure hamstrung the agency's ability to investigate other obvious uses for a device, and attempted two filibusters to remove the provision from the bill. Nevertheless, S. 830 passed 98-2 with the measure intact on Sept. 24.

Joe Barton (R-Texas) and Anna Eshoo (D-Calif.) worked out a compromise in the House bill that gave the agency the right to look beyond the device label in certain instances. The Clinton administration sent a letter to the conferees indicating the president would veto the bill should the conferees report it out with the Senate language.

The conferees endured a late session on Saturday night before agreeing to report out an FDA reform bill with the offending language removed. By 5:35 p.m. Sunday, the Senate passed the conference report and the House followed suit by 8:40 p.m.

"This conference report is the culmination of three years of hard work by dozens of Senators," said Sen. Jim Jeffords (R-Vt.), chairman of the Labor and Human Resources Committee and the sponsor of S. 830. "Some urged that we merely extend PDUFA, or that we tackle only a few issues related to drug regulation and leave comprehensive modernization to another day. I am glad that we did not choose either of those paths."

Instead, Jeffords noted Congress would be enacting "the most substantial reform of the Food, Drug and Cosmetic Act in decades."

While senators and representatives lauded the bipartisan and comprehensive nature of the bill Sunday night, Barton noted, "This is not a perfect bill, but it is a good start. I will continue to work on reforms for [the agency]."

For the biotechnology industry, the bill is as close to perfect as could be expected. Feldbaum noted the bill provides for the reauthorization of PDUFA, an agency mission statement, Fast-Track Drug approval, codification of the biologics rewrite and the dissemination of medical information on off-label uses.

"This came down to the eleventh hour, fifty-ninth minute and fiftieth second," Feldbaum said. "It didn't have to be that dramatic."

Feldbaum noted that working toward FDA reform has encouraged a collegial relationship between industry and the agency rather than the adversarial relationship of the past. He maintained that the new legislation won't prove much of a reform if it is not implemented with a spirit of cooperation.

"This is where the new FDA commissioner comes into play," Feldbaum said. "We need someone who will embrace these reforms and move forward, not someone who will grudgingly accept this legislation."

The fact that a commissioner has yet to be nominated will allow the senators to use the legislation as a standard to judge the potential nominees, Feldbaum noted. *

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