By Lisa Seachrist

Washington Editor

WASHINGTON — Pledging to iron out remaining areas of concern in its FDA reform bill covering drugs and biologics, the House Subcommittee on Health and the Environment agreed in a unanimous voice vote to report the bill, H.R. 1411, favorably to the full Commerce Committee.

The House, which has divided its FDA reform efforts into three separate bills covering foods, medical devices and pharmaceuticals, made quick business of H.R. 1411 Wednesday. Committee members repeatedly remarked that the bill, which reauthorizes the Prescription Drug User Fee Act for five years and provides for a number of broader reforms at the agency, represents a strong bipartisan effort.

"[This bill] has an impressive list of co-sponsors and will accomplish an important goal — improving the drug approval process," Subcommittee Chairman Mike Bilirakis (R-Fla.) said. "Both Republican and Democrat members of our committee sat shoulder to shoulder with the FDA to create the groundwork for the bills we are considering today."

The House version of reform for drugs and biologics bears a striking resemblance to several provisions in the Senate bill, S. 830. Like the Senate effort, which is currently being debated on the Senate floor, H.R. 1411 establishes fast- track drug approvals for new drugs and biologics intended for the treatment of serious and life-threatening conditions, streamlines the supplemental approval process, codifies the biologics rewrite and establishes a clinical trials database.

In addition, the subcommittee agreed to an amendment by Rep. Peter Deutsch (D-Fla.) that would provide the generic industry with written protocol agreements for determining the bioequivalence of generic drugs similar to the provisions for new drugs. The subcommittee also adopted an amendment from Rep. Frank Pallone Jr. (D-N.J.) requiring the agency to conduct a study of the effects of mercury used in nasal sprays.

Some Work Still To Be Done

The subcommittee left itself a heavy workload between now and the full committee markup on Sept. 26, however. Ranking minority member Rep. Sherrod Brown (D-Ohio) voiced his concerns over provisions for the dissemination of information for off-label uses. Brown withdrew his amendment to strike the provision altogether after Rep. Richard Burr (R-N.C.), sponsor of H.R. 1411, promised to work for a compromise.

Several members withdrew their amendments under the same circumstances. Deutsch objected to provisions that would offer market exclusivity to companies that conducted pediatric studies and developed new antibiotics, stating that manufacturers would work the system to keep prices up and prevent competition from generic manufacturers.

"The antibiotics provision would reward companies that already have antibiotics on the market," Deutsch said. "It doesn't promote the development of new antibiotics the way that it is written."

Pallone offered an amendment to require six months' notification to the agency should a manufacturer decide to discontinue a drug for which it is the sole manufacturer.

The Biotechnology Industry Organization (BIO) opposes that provision because, as defined, a sole manufacturer means there are no generic equivalents to it. Dominique Cahn, director of federal governmental relations at BIO, noted that often a company will change from a human tissue-based formulation of a drug to a recombinant product; or, as in the case of alpha-interferons, there is more than one version on the market.

Cahn said it is unclear whether these would constitute violations of the Food, Drug and Cosmetics Act.

Despite these areas of potential conflict, the subcommittee is moving forward toward its full committee mark-up.

"What we've seen today is a consensus in support of 1411," Burr said. "There are certainly things that we may not be able to agree upon, but we intend to refine any rough spots in the legislation so the full committee runs as smoothly as today. We hope to see the administration eager to sign this bill into law." *