By Lisa Seachrist

Washington Editor

WASHINGTON — In an overwhelming show of bipartisan support for FDA reform, the House Commerce Committee voted 43-0 to report their version of drugs and biologics reform, H.R. 1411, favorably to the House membership.

The bill, which also reauthorizes the Prescription Drug and User Fee Act (PDUFA) for another five years, is joined by a food reform bill and a medical device reform bill to encompass the FDA reform efforts in the House.

"Today is a landmark in this committee's efforts to better serve the American people," said Committee Chairman Tom Bliley (R-Va.). "After three years of work, we are about to send to the full House the most important improvements in decades in the Food and Drug Administration."

The bill now moves to a full House vote which could take place sometime next week. With few exceptions, the provisions within the bill look like they easily will mesh with the drugs and biologics provisions in the Senate FDA reform bill, S. 830, which passed Wednesday in a 98-2 vote.

While the House bill received unanimous support, several congressmen noted that in light of newly discovered serious health problems associated with off-label use of the diet combination phen-fen, a provision to allow pharmaceutical manufacturers to disseminate off-label information directly to physicians is troublesome to some lawmakers.

"I remain concerned, as I always have been, about sanctioning the distribution of literature articles about the off-label uses of drugs," said John Dingell (D-Mich.). "I am highly skeptical of the arguments that have driven this approach and I assure you that I shall remain most interested in determining whether it works."

Nevertheless, critics of the provision acquiesced in light of a Sept. 23 letter from Health and Human Services Secretary Donna Shalala to Sen. Bill Frist (R-Tenn.), noting that the dissemination of information provision in S. 830 was acceptable to the administration. The provision in H.R. 1411 is based on the S. 830 language.

Assuming that H.R. 1411 passes the House, the conference committee will need to reconcile several issues. The committee voted to add a provision introduced by Rep. Frank Pallone, Jr. (D-N.J.) that would require manufacturers who are the sole suppliers of a life supporting or life sustaining drug to notify the FDA six months before they discontinue production of that drug. The Senate removed this measure from S. 830.

In addition, the House has included a provision to create financial incentives for pharmaceutical and biotechnology companies to develop new antibiotics to battle an increasing incidence of antibiotic-resistant bacteria. Manufacturers who develop new antibiotics would be allowed an additional six months of market exclusivity.

The committee also included several provisions not found in the Senate bill that require the FDA to conduct studies. A Pallone amendment calls for the FDA to study the effect of human use of elemental, organic or inorganic mercury as a dietary supplement.

Rep. Peter Deutsch (D-Fla.) inserted language calling for the agency to study the impact of the lack of lower cost generic drugs on lower income patients. And Rep. Bobby Rush (D-Ill.) amended the bill to require the agency to develop guidance on the appropriate inclusion of women and minorities in clinical trials.

The House did not address the issue of the appropriations trigger that would allow the agency to collect PDUFA fees. The Office of Management and Budget identified the trigger language as unworkable and in violation of the balanced budget agreement. It remains unclear how the legislators intend to clear up this problem; however, the committee members acknowledged that PDUFA was the focus of the legislative effort.

"Probably the most significant step we will take today is to reauthorize the Prescription Drug and User Fee Program," Dingell said. "By every measure, the program has succeeded beyond anyone's expectations. In addition, the User Fee program has brought to FDA and the pharmaceutical industry a new spirit of cooperation and re-invigorated mutual respect." *