Senate votes to streamline FDA drug-approval process More experimental drugs for extremely ill patients


WASHINGTON -- The Senate overwhelmingly passed a bill yesterday that would enable the Food and Drug Administration to speed the availability of drugs and medical devices while giving manufacturers greater authority to review and promote their products.

The bill passed on a 98-2 vote, capping a three-year effort by Republicans to revamp the agency's regulatory authority and push it "into the 21st century," said Republican Sen. James M. Jeffords of Vermont, the legislation's chief architect.

The legislation stops short of any revolutionary reforms of the agency and the way it conducts business. All parties describe it as a moderate bill, the first significant attempt at change in more than 30 years and one that would give the agency greater flexibility as it copes with shrinking resources.

Under the bill, patients with life-threatening illnesses would have better access to experimental drugs. It would permit pharmaceutical companies to send information to doctors on "off-label" use of drugs -- uses that have not been designated by the agency -- as long as the companies pay to study the effects.

The companies must submit the information to the agency before disseminating it.

It was such an unapproved combination of diet pills that prompted the FDA to pull some diet drugs from the market last week.

The legislation would reauthorize a popular fee on the pharmaceutical industry, which speeds the agency's review of drugs and is set to expire Tuesday. The fee has allowed the FDA to hire 600 workers to conduct drug analyses and pick up the pace of drug approvals.

It would give the medical device industry more of a say in the evolution of its products, with the agency serving as the final arbiter.

The bill arrived on the Senate floor after a long intermittent filibuster by Sen. Edward M. Kennedy of Massachusetts, who vehemently opposes one of the bill's provisions and who helped broker a series of compromises on much of the legislation. He and a fellow Democrat, Sen. Jack Reed of Rhode Island, were the only two senators to vote against the bill.

Similar legislation in the House is expected to be voted out of committee today and should reach the floor in the next few weeks.

A number of senators took to the floor yesterday to hail the legislation as a long-overdue step, freeing the agency of cumbersome regulations.

Pub Date: 9/25/97

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