By Lisa Seachrist

Washington Editor

WASHINGTON — With a balanced budget in hand, the Senate took off for its August recess without bringing the joint bill for FDA reform and the reauthorization of the Prescription Drug and User Fee Act (PDUFA) to the floor for a vote.

The FDA Modernization Act, S. 830, was brought to the floor twice since its markup in mid-June, but each time it failed to make it to the floor for debate as a result of objections from the Democrats over issues in the regulation of cosmetics.

"This was extremely frustrating, even infuriating," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "We had hopes until the final minutes that we would get the bill to the floor, but it was hung up on issues that had nothing to do with biotech or drugs."

Instead, the Senate adjourned late Thursday evening to reconvene on Sept. 2. Majority Leader Trent Lott (R-Miss.) indicated he would overrule any Democratic objections should Sen. Jim Jeffords (R-Vt.), author of the bill, and Sen. Edward Kennedy (D-Mass.) fail to come to a time agreement in order to get the bill to the floor during the first week the Senate is back in September. Jeffords is chairman of the Labor and Human Resources Committee and Kennedy is the ranking Democrat on the committee.

"Despite our seemingly getting so close to an agreement last night, non-drug issues stopped the bill from hitting the floor," said Barry Caldwell, vice president for federal affairs at the Pharmaceutical Research and Manufacturers Association (PhRMA). "We were very disappointed, but the delay isn't fatal, at least not yet."

The delay in moving the FDA Modernization Act means Congress will have one month to move bills through both chambers and reconcile those bills into one piece of legislation for the president to sign before PDUFA expires at the end of September. As yet, the House has introduced no legislation regarding FDA reform or PDUFA reauthorization.

Congress, however, may have some built-in breathing room. The FDA has reported to the House Commerce Committee it will have approximately $24 million carry-over PDUFA funds from 1997. The FDA noted the fund is maintained to "ensure that funds are available to meet financial obligations incurred under PDUFA in the event of delayed appropriations or program termination."

A commerce committee spokesman said the carry-over funds should "allay fears over any layoffs or disruptions of any sort at FDA."

If those funds did not exist, the agency by law would have had to issue layoff notices to the 600 employees that have been hired with PDUFA funds. However, both Feldbaum and Caldwell said the existence of those funds doesn't eradicate the urgency in reauthorizing PDUFA.

"If the affected employees begin to doubt that PDUFA will be reauthorized, they will start to look for new jobs," Feldbaum said. "And the first to go will be the best and the brightest."

"It's a legitimate management concern," Caldwell agreed. "We understand the agency has been sending the employees monthly letters telling them that the negotiations are on track. Now that could change."

The process, however, remains on track as far as the House Commerce Committee is concerned. Committee chair Tom Bliley (R-Va.) has indicated FDA reform and PDUFA reauthorization will be a key priority upon return from the August recess. A committee spokesman noted the staff responsible for FDA reform legislation has been working on Medicare and Medicaid issues in order to create the Kidcare program while meeting with the agency, industry and patient groups over FDA reform.

"Ideally, we get this bill finished before PDUFA expires," the committee spokesman told BioWorld Today. "We want to get this done quickly, but more importantly, we want to get this done right."

During the August recess, BIO and PhRMA intend to work with congressional staffers who are in town and visit with legislators in their home districts in order to impress upon them the urgency of getting legislation passed.

"In the Senate, in the end it came down to the fact that the relationships between the senators had worn so thin it was difficult to get them to meet to work out their differences," Feldbaum said. "We have to make sure that this is at the top of the agenda after the recess." *