By Steve Usdin
Contributing Editor

WASHINGTON - The prospects for congressional action on FDA reform are likely to be clarified by the tone and substance of a hearing this week of the House Commerce Committee's health and the environment subcommittee.

The hearing, which follows two days of Senate hearings last week at which FDA Commissioner David Kessler rejected most of the specific measures contained in Sen. Nancy Kassebaum's FDA reform legislation, is likely to unveil the substance of the House approach to reform.

In particular, the House meeting may demonstrate whether the lower house is inclined to follow the bipartisan approach of the Senate, or to pursue a more ideological path that would be less likely to result in an approvable bill in the brief legislative window that remains this year.

Commerce Committee staff told BioCentury it is likely that FDA reform legislation will be unveiled in conjunction with the hearing.

Kessler sets boundaries

At last week's hearing of the Labor and Human Resources Committee, Kessler conceded the need for changes to speed the development of new therapies, but ennumerated a long list of objections to specific measures contained in Kassebaum's bill, S. 1477.