Monday, August 14, 1995
WASHINGTON - The Senate Labor and Human Resources Committee is working on FDA reform legislation that would change the agency's mission to emphasize development and marketing of new therapeutics and devices.
Under the proposals contained in a "concept paper" being circulated in Washington, the legislation would expand and codify regulatory practices designed to speed the access to drugs, such as fast track review.
It also would require biologics to be regulated under the same rules as drugs in most circumstances, reduce restrictions on promoting off-label uses of approved products, and allow sponsors to distribute scientific information about unapproved products.
The proposals are peppered with mechanisms for monitoring and measuring the agency's performance, including response deadlines, requirements for documentation of decisions, and an annual performance review under the aegis of an appointed outside "panel of experts" that would include industry representatives.
After Labor Day
The ideas contained in the concept paper are being reduced to legislative language over the August recess, a senior staff member of the committee told BioCentury. A bill, "The FDA Performance And Accountability Act of 1995," will be circulated to panel members shortly after Labor Day.