WASHINGTON _ House Commerce Health SubcommitteeChairman Michael Bilirakis (R-Fla.) Tuesday failed to introducelegislation to reform the FDA, raising questions about whetherlegislation would move through the House this year.

While many proponents of FDA reform for the past several weekshad predicted he would introduce legislation, it came as a surprisethat Bilirakis did not engage in a discussion of the principles of FDAreform. Instead he held an oversight hearing similar to those held lastyear by Rep. Joe Barton's (R-Tex.) Oversight and InvestigationsSubcommittee.

The absence of a bill from the Republican majority on the CommerceCommittee indicates a lack of unanimity between professional staffmembers and members, said one biotech industry insider whorequested anonymity. "Even though the staff has drafted several billsaimed at reforming FDA regulation of drugs, devices, foods andanimal drugs, those reform bills do not have the confidence of themembers," according to the source.

In his first statement on FDA reform at the hearing, Bilirakis said heexpects that "in the weeks ahead members of this committee willintroduce . . . reform bills for consideration by this subcommittee thatwill offer reforms for drugs, biologics, medical devices and foods."He said his priorities for legislation were to ensure patient access tonew therapeutics, access to information about off-label uses andaccess to high technology jobs for Americans. Bilirakis gave noindication when he would introduce legislation.

Bilirakis' lack of action contrasted with hearings held last week bythe Senate Labor and Human Resources Committee whose membersmade it clear that while there was bipartisan sentiment for passage ofFDA reform legislation, there was a lack of consensus on criticalissues such as limits on promotional materials. (See BioWorldToday, Feb. 23, 1996, p. 1.)

Bilirakis also postponed an appearance by FDA Commissioner DavidKessler that had been set for Thursday. Kessler now is expected totestify in March.

Barton, who in the past has made several tough statements aboutKessler's management of the FDA and the need to reduce regulationof U.S. medical products, made a low-key statement at Tuesday'shearing. Barton referred to "possible" FDA reforms, casting doubt onwhether the House will act on a bill this year at all.

Ranking Democrat Henry Waxman (D-Calif.) came out swinging,offering a sharply worded defense of Kessler and a denunciation ofpartisan tactics by the Republicans. Waxman urged the subcommitteeto reject privatization of the FDA "which seeks to shift the burden ofrisk to consumers and away from manufacturers where it rightfullybelongs." n

-- Michele L. Robinson Washington Editor

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