By Lisa Seachrist

Washington Editor

WASHINGTON — Claiming the Senate's proposal for FDA reform does nothing to strengthen protections for patients, patient organizations are looking to the House version of reform, which is set to be introduced early in September, to address their concerns.

The coalition of patient advocacy groups publicly objected to the procedure Senate Labor and Human Resources Committee chairman Jim Jeffords (R-Vt.) took in drafting the FDA Modernization and Accountability Act, S. 830, claiming that patient organizations didn't have a voice in drafting the legislation. In contrast, the House Commerce Committee staff, which will produce a bill to reauthorize the Prescription Drug and User Fee Act of 1992 and address FDA reform issues, has conducted several meetings with the groups.

"The point is that with the House, we have been brought in at the beginning of the process," said Jeff Bloom, of the Patients' Coalition. "In the Senate, we were shut out of the meetings that staff had with industry and the administration."

As a result, Bloom noted the bill has had problems reaching the floor. It went through committee mark-up on June 18, but Senate Majority Leader Trent Lott (R-Miss.) refused to bring the bill to the floor for a vote unless the majority and minority leaders, Jeffords and Sen. Edward Kennedy (D-Mass.), could reach a time agreement to limit debate and avoid a filibuster.

The committee was unable to reach a time agreement for the bill before the August recess. Lott has stated the bill will be a top priority when the Senate reconvenes in September. A Jeffords' staffer has told BioWorld Today Jeffords expects a vote in the second week of September.

"Still to this day, no one has a copy of the bill in hand," Bloom noted. "It's ridiculous to agree in theory for FDA reform. The devil is in the details."

In Kennedy's eyes, federal preemption of state authority to regulate over-the-counter drugs and cosmetics and some medical device issues were the gamebreaking details preventing a time agreement.

"In my view, acceptable compromises can be reached on both of these issues," Kennedy said in a statement, "and, I hope that good faith negotiations will continue."

In large part, those remain issues for the patients' organizations as well. The patient groups would also like to see the agency given more teeth to insist that companies conduct the postmarketing studies the agency sometimes requires as a condition for approval. And the coalition, which includes the Center for Science in the Public Interest, the Consumer Federation of America, Public Citizen and Bloom's group, expressed concern over the fast-track drug program included in S. 830.

The fast-track program was the brainchild of the Biotechnology Industry Organization to bring the agency into the drug development process very early for potentially breakthrough drugs. The drugs would receive special attention from the agency from the beginning of Phase I clinical trials through an expedited, rolling review process.

"For the fast-track drug program, we feel it is unnecessary — we think the accelerated approval process works fine," Bloom said. He stated the program is probably "better for getting investors" and "not necessarily in the interest of patients."

Bloom stated his coalition feels that S. 830 fails to offer patients any additional protections and has proposed a measure to ensure that companies conduct the postmarketing studies that the agency requires.

A May 1996 Inspector General's report found that approximately 24 percent of all companies fail to conduct postmarketing studies. However, the report also noted that the agency didn't have a procedure that could adequately monitor compliance with Phase IV commitments.

At the time of the report, the agency relied on individual reviewers to report when a Phase IV study had been completed; and there were no formal standards or procedures for monitoring or establishing whether a postmarketing commitment was met.

Since then, the agency has adopted a system that requires all approval letters to identify which drugs have Phase IV commitments as well as the type of study required. The status of those reports is then entered into a centralized database as the reports come into the agency.

The report also noted postmarketing commitments have increased from approximately 33 percent of all approved drugs in the 1970s to 70 percent in the 1990s. The use of surrogate endpoints and accelerated approvals, and the increasing number of drugs that treat chronic conditions and require long-term use, have led to the increase, said Joe Oliver, an FDA spokesman.

Another part of the problem with tracking the results of these commitments, Bloom noted, lies with the fact that the only recourse the agency has is to revoke approval of a drug that may be effective for a large number of people.

"Nobody wins when a useful drug is taken off the market — it's a terrible choice to have to make," Bloom said. "We don't want to slow or prevent the approval of important drugs, but as we move to using surrogate endpoints, we need to get the postmarket information at some point."

Fines Favored To Force Compliance

The Patients' Coalition supports a measure to assess civil penalties or fines to companies that fail to comply with requests for postmarketing studies. The money would then be used to fund the study the company failed to conduct.

Kennedy proposed such an amendment to S. 830, but the amendment was dropped in order to reach a compromise on the issue. A Kennedy spokesman told BioWorld Today the bill instead requires companies to provide annual reports of the status of Phase IV trials.

The patients' groups also have issues with the dissemination of off-label information and the expanded access program. Whether the House bill that Commerce Committee chairman Tom Bliley (R-Va.) produces will be more to their liking remains to be seen. But Bloom is hopeful.

"We expect that the House bill will be much more balanced than the Senate bill," Bloom said. "I think it will be a much smoother process in the House." *