No Major Changes In FDA Reform Bill

The US Senate Labor and Human Resources Committee will begin discussinga bill to both modernize the Food and Drug Administration and extend for another five years the 1992 Prescription Drug User Fee Act. Markup is now scheduled for June 11.

The bill will modernize the agency, speed up drug approval and concentrate FDA resources on products that are genuinely high-risk, according to bill sponsor committee chairman Senator James Jeffords. Several times, the bill states the agency will face flat or declining budgets, and that it should refocus its efforts on the prompt approval of drugs, devices and biological products. The proposed legislation would:

- amend the agency's mission statement to include the protection of the public from unsafe products and the rapid review and approval of safe and effective products; - set a single, five-year term for the FDA Commissioner, who could only serve longer if reappointed by confirmation; - give the agency greater discretion to approve a drug for additional uses or for additional patient populations; - expand access to unapproved or experimental drugs and devices outside a clinical trial to those with life-threatening or serious illness who have used all other means of treatment; - clarify procedures used to approve or deny approval to drugs and devices; - allow manufacturers to use FDA approval in product labeling, which is not allowed now; - require the FDA to show how it would comply with required approval timeframes by 1999; - suggest the agency use outside experts to review certain new technologies; - have the FDA expand its current pilot projects for outside review of medical devices by accredited outside experts; - create a program of regional drug research centers to determine new uses of medical products and unforeseen risks of approved products; and - try to improve communications between the agency and the medical device industry, so manufacturers would know what type of safety studies are required.