By Lisa Seachrist

Washington Editor

WASHINGTON--Fulfilling the promise he made in April, Sen. Jim Jeffords (R-Vt.) has released a discussion draft of his combined Prescription Drug and User Fee Act (PDUFA) reauthorization and FDA reform bill. The bill will be introduced as soon as the Senate returns from its Memorial Day recess next week.

Unlike the bill sponsored by now-retired Sen. Nancy Kassebaum in the 104th Congress, Jeffords' proposal dodges a number of contentious issues such as time frames, hammers and the dissemination of medical information in an attempt to quell the opposition that stymied reform last year.

"If you thought the pendulum had swung to the extreme of regulation in the past, we hope this legislation stops the pendulum in the middle rather than to the other extreme," a member of Jeffords' staff said at a press briefing on the bill. "This bill serves as an excellent basis for incremental reform to make the agency more efficient."

The bill provides for the five-year reauthorization of the PDUFA, which is set to expire at the end of September, codifies the biologics rewrite, and establishes a Fast Track Drug program strikingly similar to one proposed by the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA).

In a commentary about the power the FDA commissioner can wield, Jeffords also proposes a five-year term limit for the FDA commissioner, renewable only with another round of Senate confirmation hearings.

"This bill goes a very long way to addressing BIO's concerns and recommendations," BIO president Carl Feldbaum told BioWorld Today. "This is a moderate, reasonable bill that really shows the signs of new authorship."

In a written statement, the Pharmaceutical Research and Manufacturers of America (PhRMA) called the reform measures "common sense improvements to the way the FDA regulates the development of new drugs."

The bill, which will enter committee mark-up next Wednesday, establishes a mission statement for the agency which includes protecting the public from unsafe products, facilitating rapid review and approval of safe and effective products and enforcing and complying with the act in a consistent manner. Currently, the agency has no legislatively mandated mission.

In its reauthorization of PDUFA, the bill calls for a five-year extension of the program and follows the review time goals established by FDA and industry during their negotiation last fall. In addition, the bill states that the reauthorization of PDUFA is contingent upon level funding for the agency in fiscal year 1998, with increases adjusting for inflation for the following years.

The Clinton administration's fiscal year 1998 budget calls for what amounts to an 8 percent cut for the agency. Should this bill be signed into law, Jeffords is counting on the various appropriations committees to provide the funding that will permit the agency to collect PDUFA fees.

"Sen. Jeffords is 100 percent behind the reauthorization of PDUFA," a Jeffords' spokesman said. "However, he isn't on an appropriations committee, and he is not about to monkey around with the triggers that serve as the basis of the agreement between FDA and industry."

Some patient organizations, industry organizations and the FDA have questioned whether attaching FDA reform to PDUFA reauthorization may jeopardize a program that has been uniformly called a success. However, Jeffords and his staff disagree.

"FDA reform is not a danger to PDUFA," the Jeffords' spokesman said. "The danger to PDUFA is the budget."

Several sections of the bill still have to be fleshed out before the bill goes to mark-up, including the Fast Track Drug Review provision that would establish rolling reviews and more industry-agency communication earlier in the process of drug development for therapies designed to address unmet medical need for serious or life-threatening conditions. Jeffords' spokesman said that the FDA may have comments about the proposal and stated that the agency wanted to be sure that they weren't throwing their resources down a dry well.

Jeffords' spokesman also noted that the Senator had a lot of confidence in the ability of this bill to pass easily through mark-up. "We tried to be much smarter about what we put in this bill," he said.

"This bill is a very positive development and the fact that the committee acted so quickly on it is an excellent sign that we are going to see reform," Feldbaum said.

Feldbaum also mentioned some surprise at the term limit for the commissioner. "Frankly, I have never heard the term limit proposal before," he said, adding, "But it certainly isn't a gamebreaker for us." *