Monday, March 27, 1995
WASHINGTON - Genzyme Corp. has been quietly shopping a proposal for overhauling the FDA approval process through changes in the way advisory panels are convened, selected and tasked. The proposal would change the panels' mission, charging them specifically with determining if a product is safe and effective, and would place great pressure on FDA to adhere to panel recommendations.
According to Genzyme's Washington representative, Lisa Raines, the proposal is designed to redress a number of grievances the biotechnology and pharmaceutical industries have with the current process. "We have several concerns about FDA advisory committees. One is that they can serve as a useful way to resolve technical disputes between a company and an FDA reviewer. But a company has no rights to have an advisory panel review its products. FDA decides which products get reviews and if you reach an impasse with a reviewer, you have no way to insist on getting a review."
Wait a year
Raines added: "Another concern is that in many cases advisory panels have recommended approval of products and FDA has not acted expeditiously on it. One of the best examples is the chickenpox vaccine. An advisory panel recommended approval in (January) 1994 and it was approved last week. Last year, FDA advisory committees recommended approval of four different vaccines and none were approved last year. Only within the last