By Lisa Seachrist

Washington Editor

WASHINGTON — The Senate overwhelmingly approved The FDA Modernization and Accountability Act of 1997, voting 98-2 to pass the measure.

After two filibusters and several weeks debating cosmetics and a single medical device issue, only Sens. Edward Kennedy (D-Mass.) and Jack Reed (D-R.I.) voted against the bill, S. 830, which reauthorizes the Prescription Drug and User Fee Act (PDUFA) and enacts more global FDA reforms.

"This vote is beyond bipartisan," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "It represents a political breakthrough of sorts. We broke through the mindset that says any change at FDA is bad."

The bill took a tortuous route to passage, inducing two cloture votes to limit debate on filibusters threatened by Kennedy. The last two weeks were spent debating a single provision that would limit the FDA's scope of review of low- risk medical devices — the so-called 510(k) devices — to the indication stated in the manufacturers label.

Kennedy and Reed offered an amendment Tuesday that would have retained the FDA's authority to ask companies to provide data on uses of the medical device that weren't listed on the label, but that amendment was defeated 65-35.

The overwhelming vote passing the bill augurs well for a reauthorization of PDUFA in time to prevent layoffs of the more than 600 FDA employees that are funded by the PDUFA fees.

"Today's vote is a strong signal to send to the House and White House," Feldbaum said. "This was the keystone vote and it may accelerate the whole process."

Feldbaum pointed out that six months ago, no one would have predicted that S. 830 would have engendered so much support. He credits work done in the 104th Congress to educate members so that reform could pass in the 105th.

In addition, he noted a major factor in the success of the bill was ensuring all interested parties that the standard for safety and effectiveness would be kept at "a platinum level."

"FDA issues fall easy prey to demagoguery," Feldbaum said. "What we really accomplished with this legislation is to bring the regulatory process into sync with the science."

The process also spawned a relationship and dialogue between the FDA and industry that is less adversarial and more collegial, Feldbaum said.

FDA reform and PDUFA reauthorization moves to the House today with the Commerce Committee markup of the three bills that will serve as the House's vehicle for reform: H.R. 1411 for drugs and biologics, H.R. 1710 for medical devices and H.R. 2369 for food.

"We were at the House this afternoon before the Senate vote," Feldbaum told BioWorld Today, "and we were assured that the biologics and drugs [provisions] were in excellent shape." *