By Lisa Seachrist
WASHINGTON — In the wake of failing to get his FDA reform and Prescription Drug and User Fee Act (PDUFA) reauthorization bill to the Senate floor for a vote, Labor and Human Resources Committee Chair Jim Jeffords (R-Vt.) guaranteed that the delay will neither jeopardize the PDUFA program nor the jobs of nearly 700 FDA employees.
Jeffords based his assurances on the fact that his bill, S. 830, has moved quickly through the Senate, as well as on a General Accounting Office report stating that the agency has a $24 million surplus in PDUFA funds that can carry the program for at least three months past its Sept. 30 sunset date. Without those funds, the agency would have been required to send out reduction in force (RIF) notices on Aug. 1 in order to satisfy federal regulations.
"There has been the suggestion that RIF notices will have to be sent to PDUFA-funded employees in August if the fee had not been reauthorized by then," Jeffords said in a statement. "I asked for the report on the available surplus to give those employees the assurance that RIF notices are not necessary, and there will be no disruption of the FDA's activities."
The bill, which was marked up on June 18, was stymied during July by the committee's inability to resolve issues surrounding over-the-counter drugs and cosmetics. Because the bulk of Senate floor time was tied up with trying to pass the balanced budget resolution and appropriations issues, Majority Leader Trent Lott (R-Miss.) insisted that majority and minority members of the Labor and Human Resources Committee come to a time agreement before the bill could be brought to the floor without the risk of a filibuster.
"It's just a fact that during the appropriations process, non-appropriations bills have to be slipped in," a committee spokesman said. "We couldn't get a final time agreement to bring the bill to the floor before the August recess. But the bill is moving swiftly and Sen. Lott has said that it will be a priority in September."
Industry representatives have voiced concern that the PDUFA surplus will result in a complacent Congress (see BioWorld Today, Aug. 4, 1997, p. 1), but Jeffords' staff sees that as unlikely because the bill is "nearly a done deal," with no outstanding pharmaceutical, biotechnology or medical device issues to slow the process. As a result, the committee has no plans to put major work into the bill over the recess.
"The reality of this place is that a lot of things don't get done until the end of the fiscal year," Jeffords' spokesman said. "The PDUFA funds only allow the program to continue in the event that we are sitting in conference after the start of the next fiscal year. The surplus offers FDA employees whose salaries are dependent on this money the assurance that Congress is not going to be insensitive to their real human needs, like paying their bills."
In order to keep the bill on track, Lott has indicated that S. 830 will come to the floor soon after the August recess. The committee's nearest estimate is that it will see debate the second week in September. Should the bill come to the floor without a time agreement to limit debate, Lott has indicated that he would halt debate with a vote for cloture — a procedure where 60 senators can cut off debate and move a bill to a final vote — should the debate become unruly.
"The bill is going to the floor early in September," Jeffords' spokesman said. "And we expect it will pass with strong bipartisan support."
The House of Representatives is expected to introduce a bill for mark-up as soon as the recess is over. Once the two bills have passed their respective chambers of Congress, they will be reconciled in conference committee before that reconciled bill can be signed into law by the president.
"We have been working closely with the FDA and with the administration," Jeffords' spokesman said. "We expect PDUFA will be reauthorized by the end of the fiscal year." *