By Lisa Seachrist

Washington Editor

WASHINGTON -- FDA reform and user fee reauthorization efforts in the Senate garnered bipartisan support with Sen. Barbara Mikulski (D-Md.) and Sen. Christopher Dodd (D-Conn.) announcing they were signing on as co-sponsors to Sen. Jim Jeffords' (R-Vt.) Food and Drug Administration Modernization and Accountability Act of 1997.

The Senate Labor and Human Resources Committee, which Jeffords chairs, began markup of the bill, S. 830, which aims to reauthorize the Prescription Drug and User Fee Act (PDUFA) while encompassing broader FDA reform. However, constrained by a lengthy partisan debate over student loans, the committee members managed only to present opening remarks before Jeffords was forced to adjourn the committee until next Wednesday.

Nevertheless, committee members expressed their support of PDUFA reauthorization and FDA reform while remarking on the bipartisan nature of the discussions and the bill.

"This amendment offers moderate, incremental reform that continues to protect the public health and provides FDA with the new tools to manage its increasing workload," Jeffords said. "Today's legislation eliminates most of the mandatory time frames imposed last year: the 'contracting out hammer' and the 'European review hammer' have been eliminated."

Jeffords noted that those issues were key objections raised against the FDA reform bill proffered in the 104th Congress. Sen. Edward Kennedy (D-Mass.) agreed that this bill is built on far greater consensus.

"I commend Sen. Jeffords for his hard work in putting this important legislation together and his willingness to work with the Democratic members of this committee and with the FDA," Kennedy said, noting that substantial consensus has been achieved as a result. "In fact, if we were to report legislation today that includes only the items on which consensus has been achieved, we would have crafted the broadest FDA reform in decades."

Even so, Kennedy noted that the bill as it stands is not perfect and will need some revision before he would be willing to support it. Last night, compromise was reached on the regulation of radiopharmaceuticals and fast-track drug approval, Kennedy said.

Kennedy offered those compromises up as amendments, but the committee didn't have time to consider them.

In addition, Dodd offered up an amendment that would create a "clinical trials clearinghouse," allowing physicians and patients access to up-to-date information on ongoing clinical trials. That amendment as well will be considered next week.

Postponing markup on S. 830 puts the pressure on the committee to reach a consensus on any outstanding issues, including the third-party review of medical devices. Congress is under a tight deadline to pass legislation that would reauthorize PDUFA. Even though the program is set to expire at the end of September, federal rules require that the agency serve layoff notices on Aug. 1 to employees hired under the act if it has not been reauthorized by that time.

Mikulski noted that she was fortunate to have the FDA housed in her state. But she also pointed out that many of the 600 employees that would receive pink slips Aug. 1 are her constituents.

"PDUFA is legislation that has worked," Mikulski said. "And failing to reauthorize PDUFA before the layoff notices go out will only serve to further demoralize the workers who are behind that success." *