Michele L. RobinsonWashington Editor

WASHINGTON _ Rep. Joe Barton (R-Tex.) will introduce a bi-partisan FDA reform bill that will be supported by key Democraticand Republican members of the House Commerce Committee.

In an interview with BioWorld Today, Barton, who is chairman ofthe House Commerce Oversight and Investigations Subcommittee,said he is working with House Commerce Committee ChairmanThomas Bliley (R-Va.) and Commerce Health SubcommitteeChairman Michael Bilirakis (R-Fla.) to discuss the principles behinda bipartisan bill.

Barton said he expects Rep. Ron Wyden (R-Ore.), who already hasdeveloped a broad outline of an FDA reform plan but has notintroduced legislation, and ranking Democrat John Dingell (R-Mich.)will join them.

Not on Barton's short list is former House Commerce HealthSubcommittee Chairman Henry Waxman (D-Calif.). "I have nottalked formally with Mr. Waxman but he has extensive knowledge ofFDA that would be valuable," said Barton.

At the May 25 hearing that Barton's subcommittee held on how FDAreviews impede access of biotech products to the market, Waxman onseveral occasions defended the status quo, including FDA's toughpolicy on reviewing all manufacturers' products claims. (SeeBioWorld Today, May 26, 1995, p. 1.)

Barton wouldn't commit on a date for the introduction of the plannedlegislation.

Barton said he will hold one more hearing on FDA reform. No datehas been set but committee aides said it probably will be held laterthis summer.

That hearing will focus on management weaknesses at FDA. At theMay 25 hearing, Barton indicated an interest in holding a fieldhearing at FDA headquarters to examine such issues as systemsintegration, information management, layers of bureaucracy andallocation of resources.

"Regulating the agendas at professional society meetings seems to bean inappropriate allocation of resources," Barton told BioWorldToday. He was referring to a statement made to his subcommitteethat the FDA had requested approval of presentations at the recentAmerican Society of Clinical Oncology meeting that involved certainoncology drugs.

FDA reform legislation is not proceeding at a fast pace but Barton isnot discouraged. He was in fact optimistic about reporting a bill outof his committee this year. But that does not take into account actionby the Senate Labor and Human Resources Committee, which alsohas jurisdiction over FDA reform, as well as the time necessary forHouse and Senate floor debate and joint deliberations to resolvedifferences in versions passed by the two houses.

The medical products industries are not in agreement on how theagency should be reformed. Both the Biotechnology IndustryOrganization (BIO) and the Health Industry ManufacturersAssociation, representing medical device manufacturers, havedeveloped different legislation that specifies how they want FDAreformed. The Pharmaceutical Research Manufacturers of America's(PhRMA) members have not reached a consensus on FDA reformand have delayed unveiling their plan.

The biggest risk to FDA reform legislation is delay caused by thebudget reconciliation bill. Looming over all legislation is thecontinuing battle over domestic spending between the Clintonadministration and the GOP-led Congress. The budget debate isexpected to dominate Congress at least into late fall and somelobbyists said as late as December. But Barton said that he did notexpect the current budget debate to interfere with hearings andcommittee mark-up of an FDA reform bill by the CommerceCommittee.

Just added to the budget equation has been the suggestion from theadministration that it wants modest health care reforms on the tablewhen Congress discusses cuts in Medicare and Medicaid. What thoselimited reforms might be has yet to be unveiled by the White House.

But it would probably include previously discussed curbs on certainhealth insurance practices such as limits on pre-existing conditions.New initiatives might be introduced, such as medical savingsaccounts, supported by several conservative Republican members ofCongress, as a way to reinforce consumers' buying power in thehealth insurance market.

Whether these limited health care reforms would include drug pricingcontrols is an open question. n

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

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