WASHINGTON _ Medical product liability reform (H.R 956)appears headed for defeat in the Senate. Opponents have beensuccessful in convincing a sufficient number of Senators that the billwould weaken consumer protection against unsafe products, severallobbyists told BioWorld.

The Senate began debate on product liability reform Monday and wasexpected to continue deliberation late Thursday.

Biotech company lobbyists also said they don't expect the Senate toaccept an amendment to the bill called the "FDA defense." Theamendment would permit medical products manufacturers to shieldthemselves from punitive damages if their products had been clearedby the FDA and no damaging information had been withheld fromthe agency.

The FDA defense was not included in the bill now being debated onthe Senate floor because the bill's sponsors considered the provisiona political liability. Medical products manufacturers had lobbied foradoption of the FDA defense amendment on the Senate floor. Similarlanguage was added to the House bill during floor debate.

Divisions in the Senate over product liability reform became clearearlier this week when the Senate Labor and Human ResourcesCommittee killed punitive damage caps in medical malpractice cases.Limiting punitive damages has been one of business' objectives intort reform.

The Senate debate on product liability is occurring as seriousdivisions emerge within the Senate Republican leadership over howto balance the federal budget. Senate Budget Committee ChairmanPete Domenici (R-N.M.) does not have enough votes to get his firstbudget resolution reported out of his committee. Key Republicans arenot behind the budget resolution for various reasons, includingDomenici's decision not to seek a tax cut until budget cuts wereenacted.

Domenici's task is made difficult by the size of Medicare cuts neededto balance the federal budget by 2002. Such sharp reductions inMedicare payments to providers and imposing higher co-payments onseniors are expected to elicit sharp opposition to the budgetresolution.

The debate on how to balance the budget is important to biotechmanufacturers because the more controversial that debate becomes,the slimmer the chances Congress will have time to devote to FDAreform legislation, biotech lobbyists told BioWorld. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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