By Lisa Seachrist
WASHINGTON — The end of summer recess signals the beginning of the busy school year for students and their parents across the country.
For the biotechnology and pharmaceutical industries, the end of the August recess for Congress marks a new beginning in the effort to get FDA reform passed and in the process reauthorize the Prescription Drug and User Fee Act (PDUFA) before it expires at the end of September.
"This is a very real deadline," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "The good news is this is when the House and Senate work their best — when they are under intense time pressure."
As Congress reconvenes today, BIO and the Pharmaceutical Researchers and Manufacturers of America (PhRMA) are banking on the lawmakers returning to Washington refreshed and ready to enact legislation that will encompass FDA reforms and PDUFA reauthorization by September 30. Both industry organizations are prepared to work with the legislators to reach that goal.
"Our mandate is to help craft and support an FDA reform and PDUFA reauthorization bill," said Rich Buckley, legislative council for PhRMA. "Everyone was so burned out after the July session, and we pushed so hard to get a bill to the Senate floor for a vote, that I think everyone needed the time off in August."
In order to get PDUFA reauthorized before it expires, the Senate must vote on its bill S. 830, the FDA Modernization and Accountability Act, the House must introduce and pass its own bill and, finally, those two bills must be reconciled in a form that President Clinton is willing to sign into law.
On the Senate side, Labor and Human Resources Chairman Jim Jeffords (R-Vt.) held a mark-up for the bill on June 18, but the bill failed to make it to the Senate floor for a vote for the entire month of July because Jeffords and ranking minority leader Sen. Edward Kennedy (D-Mass.) couldn't come to a time agreement. In the end, it was issues pertaining to the labeling of cosmetics and over-the-counter drugs that stymied the bill.
"At the last minute, we found ourselves brokering compromises on issues that had nothing to do with biotechnology in order to get the bill to the floor," Feldbaum said. "Everyone was just so frayed and frazzled that we just couldn't bring people together."
While the Senate was engaged in cantankerous politics over the bill, the House, as yet, hasn't introduced a bill for consideration. A bill is expected to be introduced for mark-up in the Health and Environment Subcommittee of the Commerce Committee in mid-September.
The task of getting such legislation through both chambers of Congress may seem daunting, but Feldbaum and Buckley think Congress can have legislation ready for the president to sign in three and a half weeks if the members are determined and focused.
"The House moves much more quickly than the Senate. They could move a bill from subcommittee mark-up to passage on the floor in a week if they stay focused," Buckley said. "In the Senate, [Majority Leader] Trent Lott (R-Miss.) has indicated that he will move to cloture in order to get a vote on the bill."
In moving to cloture, the Senate votes to limit the debate in order to get a bill to the floor.
"We are now at the point where we need to take the issues that have consensus and move on them," Feldbaum said. "Other issues will have to be resolved separately."
When Jeffords and House Commerce Committee Chairman Tom Bliley (R-Va.) originally indicated that PDUFA reauthorization would serve as a vehicle for FDA reform, many felt those issues would unnecessarily slow reauthorization. Feldbaum, however, noted most of the drug, biologics and device issues in the Senate bill have achieved consensus and are reasonable proposals.
Buckley agreed, noting "these reforms are founded on sound science. Crafting the Senate legislation was a very thoughtful and deliberate process."
The path PDUFA reauthorization ultimately takes may provide for a harrowing ride, but Feldbaum and Buckley pointed out PDUFA has widespread industry, administration and consumer support which will likely spur the legislators into action.
"We have been trying to remind everyone we can that this is a fantastic bill that is running out of time," Buckley said. "It would be a real shame if anything happened to the PDUFA program." *