By Lisa Seachrist

Washington Editor

WASHINGTON — Noting that control over FDA reform measures and the reauthorization of the Prescription Drug and User Fee Act (PDUFA) has moved from Rockville to the Hill, the Pharmaceutical Research and Manufacturers of America (PhRMA) outlined its legislative approach this week.

As legislative activity heats up in Congress, PhRMA is working in concert with the Biotechnology Industry Organization (BIO) to enact legislation in the 105th Congress which failed to pass in the contentious 104th Congress. Alan Holmer, president of PhRMA, pointed to FDA reform, PDUFA II, patent reform and medical privacy as the highlights of the organization's agenda in this congress.

"Increasingly, there is a developing momentum on the Hill for the renewal of PDUFA and level funding of the agency," Holmer said. "We've participated in dozens of meetings and are very pleased by the widespread support."

PDUFA * the legislation that assesses user fees to pharmaceutical companies in return for faster reviews — expires at the end of September. Senate Labor and Human Resources Committee chair Jim Jeffords (R-VT) stated his desire in March to link FDA reform and PDUFA reauthorization.

"We had a different fact pattern last year," said Barry Caldwell, vice president for federal legislation at PhRMA. "Last year it was just FDA reform, and many people don't understand that need. This year we have PDUFA and FDA reform, and people understand that PDUFA has been a success."

PhRMA, BIO and FDA have been meeting since October to hammer out the details of reforms linked to PDUFA. Those improvements include written protocol agreements, timelines for meetings and review times for standard therapies in 10 months rather than 12.

"We have had an excellent dialogue with the agency and these improvements will cut drug development and approval time by 10 to 16 months," Holmer said. "However, those 10 to 16 months will be completely lost if funding for the agency is not maintained."

The Clinton Administration's fiscal year 1998 budget calls for an 8 percent reduction in appropriations for the agency while assessing higher user fees to the pharmaceutical and biotech industries and introducing user fees to industries that have never agreed to them. Holmer said that the nature of the PDUFA legislation is that those fees are to be added to the agency appropriations, not a support for a budgetary crisis.

"Both sides have said that it is not going to be easy to return the money to FDA," Caldwell said. "And we don't want to stand in the way of a balanced budget in 2000. But we also expect to get level funding for the agency."

Holmer noted that the pharmaceutical and biotechnology industry will make a $32 billion investment in research in 1998. "It would be a real shame for that investment to be caught up by a $68 million appropriations shortfall," he said.

Rumors have started to fly around that Hill that some members of Congress are supporting a one-year extension of PDUFA in order to buy time to come up with appropriate legislation. Caldwell suspects that because no names have been circulated with the proposition, the rumor started with staffers who are concerned that they will run into a "crunch time" right before Congress adjourns.

Regardless of the source of the rumors, Holmer maintained that PhRMA is adamantly opposed to any efforts to simply extend PDUFA by one year. For one, he pointed out that it would make the agency's long-term funding uncertain, which may force the best reviewers to look for other jobs. In addition, it would make it very difficult for that agency to plan.

"The agency intends to go to a paperless submissions process," Homer noted. "If they don't have secure funding, there is no way for them to plan to make that improvement."

Compared to last year's efforts at FDA reform, PhRMA is actively seeking the support of patient groups to help make the reforms that will get needed drugs to patients earlier. At the Labor and Human Resources Committee hearing on reform last week, the Patient's Coalition had come out against including any FDA reform legislation in the PDUFA reauthorization bill because FDA reform was not a consensus issue. But since that time, Holmer said that the coalition would not oppose any consensus reforms included in the legislation. "This is a definite departure from their testimony," he said.

While several genetic privacy bills have popped up this year, PhRMA supports the view that genetic information is just another part of medical information which should be private. PhRMA, however, also maintains that any legislation to protect medical records needs to protect research at the same time.

"This is an important issue, but so far there doesn't seem to be a groundswell of support for moving these issues," Holmer said. "But we should have national standards." *