DATE: Monday, November 10, 1997             TAG: 9711100052

SECTION: FRONT                   PAGE: A3   EDITION: FINAL 
SOURCE: ASSOCIATED PRESS

DATELINE: WASHINGTON                        LENGTH:   59 lines

MAJOR FDA REFORM HEADS TO CLINTON

Culminating years of work, Congress on Sunday approved legislation that will bring basic changes to the Food and Drug Administration and accelerate the approval of lifesaving drugs.

The bill, headed to President Clinton for his expected signature, gives Congress one major achievement as it brings a quarrelsome and highly partisan session to a close.

It ``represents our best effort in many years to improve the health and safety of all Americans,'' said Rep. Michael Bilirakis, R-Fla., head of the House Commerce health subcommittee.

The House passed the measure by voice vote just hours after Senate approval, which also came on a voice vote.

The bill expands patient access to new drugs for life-threatening illnesses, provides for accelerated approval of some drugs and medical devices and allows the Health and Human Services secretary to accredit independent third-party groups to speed up reviews of low-risk devices.

It also reauthorizes a five-year program under which fees paid by drug companies have gone to hire 600 new reviewers who have helped cut the backlog in new medicine approvals. Incentives are included for developing and testing medicines for children.

``The process of moving this bill to enactment over the past four years has been long, difficult and contentious,'' said Sen. Edward Kennedy, D-Mass., who held up the legislation for weeks this fall as he fought for changes in provisions he thought were detrimental to consumers.

``But the final bill is a victory for public health, for patients, and for industry alike,'' he added.

Sen. Jim Jeffords, R-Vt., chairman of the Labor Committee that shepherded the bill through the Senate, said it was the first major reform of the FDA in 30 years. It ``will have a positive impact on the lives of millions of Americans for decades to come,'' he said.

The bipartisan agreement came after extensive negotiations on a number of controversial issues:

The final bill gives the FDA the right to request data for medical device use not listed on its label. Originally, the FDA had no authority to question off-label uses of low-risk devices.

As in the original bill, drug companies will be able to circulate reputable journal articles about off-label use of drugs, but the FDA will also be able to review and approve those articles.

Third-party review for medical devices was limited to apply mainly to lower-risk devices. The administration, which has praised the bill as a whole, had mentioned the broad scope of these reviews as one of its last objections.

The final legislation preserves state authority to regulate cosmetics.

Public Citizen, the consumer group that has lobbied hard against the FDA bill, continued to warn that allowing off-label promotions and third-party reviews would jeopardize public health.

``Congress and the president should reject putting private wealth ahead of public health and turn down the FDA conference report,'' said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. KEYWORDS: FDA

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