By Lisa Seachrist

Washington Editor

WASHINGTON — Following the Senate's lead two weeks ago, the House passed its FDA reform and Prescription Drug User Fee Act (PDUFA) reauthorization legislation in a unanimous voice vote.

The House rolled three FDA reform bills into one, H.R. 1411, encompassing changes to the way the agency regulates drugs, devices and foods as well as reauthorizing PDUFA, which expired on Sept. 30.

"If you had told me three years ago that FDA modernization would come before the House on the suspension calendar, I would have asked you to see your doctor," Commerce Committee Chairman Tom Bliley (R-Va.) said.

"All three of these measures prove, once again, that men and women of good will, working together, can bridge differences. When we put the interests of the American people first, there is nothing that can keep us apart."

Speaking in favor of the bill on the House floor was an unlikely coalition of conservatives and liberals. Reps. Richard Burr (R-N.C.), Joe Barton (R-Texas), Anna Eshoo (D-Calif.) and Henry Waxman (D-Calif.) all urged their colleagues to pass the bill.

Carl Feldbaum, president of the Biotechnology Industry Organization (BIO), praised the cooperation among lawmakers. "I'd like to keep this particular coalition together and move forward," he said.

The bill now moves to conference committee before a conference report can be approved by the House and Senate and signed into law by the president.

H.R. 1411 contains so many similarities to the Senate's version of FDA reform, S. 830, that the conference committee likely will be "remarkably undramatic," Feldbaum told BioWorld Today.

One key difference in the scope of review for medical devices may actually make the conference run more smoothly. Sen. Edward Kennedy (D-Mass.) strenuously opposed the language in S. 830. The House, however, worked out a compromise that may address Kennedy's concerns.

Most importantly, a smooth conference will allow for the reauthorization of PDUFA before the carryover funds run out, obviating the need to lay off the FDA reviewers that are funded by the program.

"The 600 plus Food and Drug Administration reviewers hired under the Prescription Drug User Fee Act also should be encouraged by today's vote as it brings PDUFA one step closer to renewal," said Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America. "We are confident that the differences between the two bills can be ironed out quickly in conference to everyone's satisfaction."

"This legislation continues to move in the right direction. I would expect it could be signed into law by the end of the month," said Feldbaum. "I now have more confidence that this bill will be enacted than the Orioles will win the World Series."

The Clinton administration, however, issued a statement noting that two provisions in the House bill are of major concern. First, the PDUFA funding mechanism requires that the FDA receive level funding which the administration claims goes against the balanced budget agreement. And, the administration prefers the Senate's version of third party review which allows the FDA to exempt any device that is of substantial importance in preventing the impairment of human health. *

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