FDA wins some concessions

WASHINGTON - Responding to agency criticisms of his FDA reform proposals, Senate Labor and Human Resources Committee Chairman James Jeffords (R-Vt.) last week released a significantly modified version of the Food and Drug Administration Modernization and Accountability Act of 1997 (S. 830). Many of the proposals that would have required the agency to adopt a more active role in promoting public health, such as informing patients and physicians of the availability of investigational therapies, have been removed.

But while the tone and some of the substance of S. 830 are less change-oriented than the discussion draft floated last month (see BioCentury Extra May 29 and BioCentury June 2), key biotechnology and pharmaceutical industry demands have been retained...