By Lisa Seachrist

Washington Editor

WASHINGTON — FDA reform and the reauthorization of the Prescription Drug and User Fee Act (PDUFA) took center stage in both chambers of Congress Thursday with the House releasing a discussion draft of its bill, H.R. 1411, and the Senate coming to a compromise on a key sticking point in its bill, S. 830.

The House Commerce Committee released its first of three bills covering FDA reform. H.R. 1411 covers the reauthorization of PDUFA and pharmaceutical and biologics reforms and will enter Health and Environment Subcommittee mark-up on Tuesday.

The Senate resolved a controversial provision in S. 830 concerning the federal preemption of a state's right to regulate cosmetics and over-the-counter drugs.

The two moves increase the chances that PDUFA will be reauthorized before it expires on Sept. 30. Even if PDUFA fails to win reauthorization before it expires, the agency has funds to carry it into early next year.

"It certainly does appear to be moving in the right direction on both sides of Congress," said Dominique Cahn, director of federal governmental relations at the Biotechnology Industry Organization (BIO). "I'm looking forward to the mark-ups and getting both bills through before the end of the month."

The discussion draft of H.R. 1411 is in the form of a substitute to a bill introduced by Rep. Richard Burr (R-N.C.) which dealt with some FDA reforms but didn't address PDUFA and was never considered by the subcommittee. Provisions in the discussion draft bear the mark of extensive discussions between the House and the Senate on reform issues and look to readily jibe with provisions in S. 830.

Like S. 830, H.R. 1411 provides for incentives for conducting pediatric studies, a clinical trial database and a provision stating that in certain cases a single clinical trial with supporting data is acceptable for approval. The House legislation also codifies the biologics rewrite and the regulation of human tissue.

The House bill even borrows the language of S. 830 for provisions to improve access to unapproved therapies and streamline the supplemental application process. The move to use S. 830 language should save the House time in some key areas. For example, in the Senate, the access to unapproved therapies provisions concerned agency officials and resulted in compromise language.

In addition, the House bill provides for fast-track drug approval for breakthrough drugs designed to treat serious and life-threatening illnesses, a mission statement and international harmonization of regulatory requirements.

Little Difference In House, Senate Bills

"Most of the differences that I see in the language between the bills appear stylistic rather than substantial," Cahn said. "We have to look at the dissemination of medical information and the healthcare economic claims more closely. If there are any differences they are probably minor."

A potential area of difference between H.R. 1411 and S. 830 could lie in a placeholder for language to provide the federal preemption of state regulation of cosmetics and over-the-counter drugs provision. Sen. Edward Kennedy (D-Mass.) so vehemently opposed that provision he threatened filibuster and forced the Senate to invoke cloture to keep the bill on track.

Kennedy and the provision's proponent, Sen. Judd Gregg (R-N.H.), agreed to limit the federal preemption only to situations where the FDA has already taken appropriate action in a specific area. In areas where the agency has taken no action, the states have the right to fill the gap.

A Kennedy spokesperson told BioWorld Today, "We won on this one."

This compromise clears Kennedy's major problem with the legislation. However, because Kennedy voiced concern over certain medical device and environmental provisions, Majority Leader Trent Lott (R-Miss.) made a motion for the Senate to vote for cloture to limit the amount of time the bill would be entertained on the Senate floor. That motion will ripen for two days and the Senate will vote to invoke cloture on Tuesday.

"The motion for cloture should not be seen as a hostile motion," Kennedy's spokesperson said. "We see the remaining issues as solvable. It is possible that we could end up voting on the bill on Tuesday, but that isn't a sure bet."

Kennedy remains concerned with the provisions in the bill that limit the scope of medical device review to the manufacturers' stated use of a product, limit the agency's ability to regulate manufacturing and exempt the agency from environmental impact review.

With both bills moving toward passage, Cahn noted that, at least for the pharmaceutical and biologics issues, "the conference committee should run pretty smoothly." *