WASHINGTON - Senate Labor and Human Resources Committee Chairman Nancy Kassebaum, R-Kan., signaled the start of substantive debate about FDA reform last week by releasing a draft of the "Food and Drug Administration Performance and Accountability Act of 1995."

The legislation would dramatically alter the way FDA reviews and regulates therapies by streamlining the approvals process. It would change the way sponsors interact with the agency by fostering collaboration in all aspects of the approvals process from clinical trial design to the review process. And the balance of power between FDA and sponsors would be altered by making the agency more accountable for its actions and by giving sponsors additional formal and informal appeals procedures.

"It is the starter pistol in the legislative race to reform FDA," said BIO President Carl Feldbaum. He said the bill "definitely advances and potentially accelerates the general debate about FDA reform."

Concrete proposals

The draft legislation, which has been circulated among committee members, is based on a "concept paper" that was circulated in August (see BioCentury, Aug. 14).