FDA Not So Slow, Studies Say

EXECUTIVE MEMO

FDA Not So Slow, Studies Say

ate last year the Food and Drug Administration, which has long been assailed by both liberal and conservative activists for foot-dragging on drug and medical device approvals, finally got some good news. The agency won high marks in several assessments of its review processes.

According to a General Accounting Office report, between 1987 and 1992, FDA shaved two weeks from the average review time for new drugs. Since then, reviews have sped up even more, thanks to a user-fee program begun in 1992. Fees paid by pharmaceutical firms applying for FDA approval allowed the agency to add 250 new reviewers in fiscal 1994, and another 250 reviewers were slated to come aboard by the end of 1995.

FDA expected to collect $75 million in 1995, up from $35 million in 1993, the first year fees were required.

With the user-fee program, 96 percent of new drug, vaccine and biotechnology product applications are acted on within the statutory 12- to 15-month time limit, according to a December report by the FDA.

The agency also reported it approves new drugs faster than Great Britain, Germany and Japan, countries which, along with the United States account for 60 percent of drug sales worldwide. More often than not, a drug approved by at least one of the other countries had been approved first by the FDA.

"We've learned to be fast when we need to be fast. We're cautious when we need to be cautious," FDA Commissioner David Kessler said at the Dec. 12 meeting of the Food and Drug Law Institute, according to The Washington Post.

Kessler said the success of user fees in speeding up drug approvals could be repeated for medical devices, if only device manufacturers would follow pharmaceutical companies in helping to pay for FDA reviews. Congress rejected a 1994 bill requiring medical device firms to pay fees for FDA reviews.