Reform Bills Set for Showdown

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published June 1996

FDA Reform

Advocates and opponents of comprehensive FDA reform are focusing their attention on four bills developed in recent months by congressional committees with jurisdiction over FDA--the Senate Labor and Human Resources Committee and the House Commerce Committee. If FDA reform is to occur this year, say sources, these bills are the likely vehicles.

On the Senate side, the Food and Drug Administration Regulatory Reform Act of 1996 (S. 1477) was introduced by Senator Nancy Kassebaum last December, and was reported out of the Senate Committee on Labor and Human Resources at the end of March. Floor debate on the bill has not yet been scheduled, but could take place as early as mid-June.

The House has taken a different approach, using three bills to address the product- specific areas of medical devices, drugs and biological products, and foods and animal drugs. Together with the others, the Medical Device Reform Act of 1996 (H.R. 3201) was referred to the Commerce Committee last March. Hearings on FDA reform were held by the health subcommittee at the beginning of May, and mark-up of the three bills was expected to occur in late May or early June.

Among the more controversial provisions of H.R. 3201 are those that would permit third-party reviewers to make the final determinations on 510(k) clearances for Class I and Class II devices. Opposition to giving external reviewers final authority has been voiced by both FDA commissioner David Kessler and Senate Democrats. Also controversial are provisions in the House bill that would permit dissemination of information about off-label uses under certain circumstances; equivalent provisions in the Senate bill were removed during mark-up.

Changes in the reform bills are expected to be made during mark-up and floor consideration. According to Capitol Hill sources, a House-Senate conference on the bills is unlikely to occur before the end of June.

Clinton administration support for reform legislation may depend heavily on the nature of the compromises reached in conference. According to Sally Katzen, administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget, the administration is approaching change cautiously. Speaking at the annual meeting of the Medical Device Manufacturers Association last month, Katzen said the administration is "interested in legislative reform and not opposed to it," but cautioned that President Clinton is determined to "ensure balance and true bipartisan reform."