By Lisa Seachrist

Washington Editor

WASHINGTON — With Congress set to recess Aug. 1, it is looking more and more likely action on FDA reform and the reauthorization of the Prescription Drug and User Fee Act (PDUFA) will be left for September's agenda.

Reform and PDUFA reauthorization legislation have hit snags in both the House and Senate that make it difficult for either chamber to pass legislation before the August recess. Industry and congressional representatives, however, remain confident PDUFA will be reauthorized before it is set to expire Sept. 30.

"This has been an effort wracked with frequent frustration," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "But the undercurrent is flowing strongly in our direction."

Jeff Trewhitt, assistant vice president for communications with the Pharmaceutical Researchers and Manufacturers of America (PhRMA), agreed. "We are comfortable that the Senate bill is moving along nicely. Every indication is that this bill will be done by the August recess or very early September," he said.

The Senate has the best chance of passing legislation. With Labor and Human Resources Chairman Jim Jeffords' (R-Vt.) bill S. 830 through committee markup, the Senate has only to introduce it to the floor for debate and a vote.

The bill was scheduled for floor debate Monday but was taken off the schedule by Majority Leader Trent Lott (R-Miss.) when majority and minority leaders could not come to a time agreement. Because the Senate is trying to work out a number of appropriations issues before the recess, Lott has insisted that any bill coming to the floor arrive with a "time agreement" that stipulates the time for debate of the bill as well as the amendments that will be proposed. Without a time agreement, a bill can become the victim of a filibuster.

Delay On FDA Bill Called Unnecessary

Jeffords voiced his disappointment over the failure to achieve a time agreement for bringing S. 830 to the Senate floor for debate, noting he was "especially chagrined given the months of bipartisan negotiating that have led to this bill."

In his floor statement, Jeffords highlighted areas of contention in which the committee was ultimately able to reach consensus, such as third-party review for devices and expanded access to experimental therapies.

"Each major provision — all of the drug and medical device provisions of this measure — represents long-sought agreements with the minority and with the FDA itself," Jeffords said. "I do not understand this continued delay. In particular, Senator Kennedy has played a key role in reaching this agreement. And I wish to applaud his willingness — and his tenacity — in working through several difficult issues to reach a consensus on this legislation."

Kennedy (D-Mass.) and Jeffords, however, haven't been able to pull together a time agreement, with a major sticking point being provisions in potential amendments dealing with the regulation of cosmetics rather than issues with provisions actually in the bill itself.

"We are continuing to negotiate with the Democrats in good faith," a Jeffords' spokesman said. "We are going to get this legislation passed.

The House, however, has no legislation pending and doesn't plan on dealing with the issue of PDUFA reauthorization or FDA modernization until Congress reconvenes after Labor Day. There are rumors the House will simply adopt the Senate's version of the bill. However, even if it does, the lawmakers have left themselves only three weeks to get the legislation signed into law before PDUFA expires.

In addition, federal regulations require the FDA to provide a two-month notice to employees when layoffs are about to occur. Technically speaking, FDA would need to send out pink slips to the more than 600 reviewers hired with PDUFA funds at the end of this week in order to comply. However, a Jeffords' spokesman said the agency has expressed no concerns about Congress and the administration failing to reauthorize PDUFA, making it unlikely the FDA will take such action.

Even so, Trewhitt pointed out that should PDUFA fail to get reauthorization in a timely fashion, "the best reviewers hired by the agency may decide the safest course of action is to look for jobs in other agencies or industry.

"We have been stressing to Congress the urgency of taking action," Trewhitt said. "We have been repeating ourselves on that point over and over again."

The National Governors' Association has taken action as well, urging Lott to move for swift passage of S.830, noting that the pharmaceutical, biotechnology and medical device industries employ hundreds of thousands of people nationwide and are essential for the health of the nation's economy.

Feldbaum noted there is vast consensus on the majority of the issues in the Senate's bill, and while it is important to hear opposing viewpoints, "it is now time to act."

"I am hoping this week will be exciting," Feldbaum said. "I expect that the Senate will come to a time agreement and S. 830 will be scheduled for debate and a vote on Tuesday or Wednesday." *