DATE: Wednesday, October 8, 1997            TAG: 9710080481

SECTION: FRONT                   PAGE: A5   EDITION: FINAL 

SOURCE: ASSOCIATED PRESS 

DATELINE: WASHINGTON                        LENGTH:   52 lines

HOUSE MOVES TO QUICKEN FDA'S PACE THE FDA APPROVAL PROCESS HAS BEEN CALLED TOO SLOW.

The House approved fundamental changes in the way the Food and Drug Administration operates Tuesday in an effort to speed approval of breakthrough drugs and medical devices.

``We helped a lot of people this morning, and in this place, we don't do that enough,'' Commerce Committee Chairman Tom Bliley, R-Va., said after the FDA bill cleared the House.

The unanimity came after three years of intense negotiations over how to streamline the FDA's approval process for drugs and medical devices without sacrificing safety. The Senate spent several months in debate before passing its version of the bill 98-2 last month.

House-Senate differences were minimal, and the goal was to draft a compromise bill in the next few weeks, congressional staff said.

The administration voiced some concerns over the House bill, particularly over provisions that would allow for third-party reviews of some lower-risk medical devices. But it said the bill, which cleared up some problems leftover from the Senate bill, ``represents a significant step toward accomplishing the mutual goal of assuring the Food and Drug Administration's optimum performance while protecting the health of the American public.''

The FDA regulates food, drugs and cosmetics - goods that make up some one-quarter of the gross domestic product. Although reforms in recent years have cut the time for getting new drugs and equipment on the market, it is still faulted by some for taking years to complete new drug reviews.

Among the main features of the bill, it would make it easier for doctors to get access to experimental drugs and set up a fast-track procedure for drugs that may be used for serious or life-threatening diseases.

It would authorize anew a five-year program under which fees paid by drug companies go to hiring 600 new reviewers to speed up approvals of new medicines.

In another measure designed to expedite reviews, it would allow the Health and Human Services secretary to accredit independent, third-party groups to conduct initial reviews of low-risk devices. That raised some concerns that experts with industry connections could have a conflict of interest.

``We have given the FDA the tools it needs to alleviate the suffering of American patients,'' said Rep. Mike Bilirakis, R-Fla., chairman of the Commerce health subcommittee. ``We have also removed the obstacles that delay the drug and medical-device approval process.''

The House did reach a compromise on one issue that tied up the Senate for weeks - language that bars the FDA from reviewing uses of lower-risk devices other than those stipulated on the label. Sen. Edward Kennedy, D-Mass., strongly objected, saying that would encourage unapproved and dangerous uses of devices.

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