Ride For Life: FDA speeds new drugs to market

Copyright 2002 National Public Radio (R). All rights reserved. National Public Radio (NPR) SHOW: Morning Edition (10:00 AM ET) - NPR May 1, 2002 Wednesday LENGTH: 920 words ANCHORS: BOB EDWARDS REPORTERS: JOANNE SILBERNER

BOB EDWARDS, host:

This is MORNING EDITION from NPR News. I'm Bob Edwards.

Ten years ago, Congress ordered a major change in the way the Food and Drug Administration does business. Drug companies had to start paying the FDA to review their products. In return, the FDA would review drugs more quickly. The legislation that created that system is up for renewal. NPR's Joanne Silberner reports on what happens when an industry finances direct government oversight. JOANNE SILBERNER reporting:

A year ago, the Food and Drug Administration approved a leukemia drug called Gleevec in less than three months. In the 1980s, the process typically took years. The difference is a law passed in 1992 called the Prescription Drug User Fee Act. Because of the law, drug companies paid the FDA $140 million last year. Dr. Janet Woodcock says the user fees are allowing her agency to do a better job.

Dr. JANET WOODCOCK (Food and Drug Administration): That concept is working for us. We're getting drugs reviewed efficiently, approval times have dropped and we haven't lower our standards.

SILBERNER: She's not the only one happy with the changes. Shelby Oppenheimer(ph) is a 35-year-old housewife with a four-year-old daughter and a fatal neurological disease, amyotrophic lateral sclerosis.

Ms. SHELBY OPPENHEIMER: I've lost the ability to drive and I can no longer write. I can't cut my own food. I can't braid my daughter's hair or tie her shoes.

SILBERNER: Oppenheimer is watching the FDA carefully, and she's comfortable with the agency taking money from the industry is regulates.

Ms. OPPENHEIMER: People in my position with either a debilitating or a fatal illness are looking for any type of procedure to be in place so that when drugs do become available they can get them out to us as quickly as possible.

SILBERNER: The FDA was once very unpopular with the companies it regulated. Jeff Trewhitt is a spokesman for the pharmaceutical industry trade group that lobbied for the user fee legislation.

Mr. JEFF TREWHITT: There was a real concern that the Food and Drug Administration drug approval process was too slow. And in fact, the average review time for a new drug application was 30 months back then.

SILBERNER: Now companies pay the FDA $330,000 to consider a new drug. In return, the agency promises to give the companies an answer in six to 12 months. Trewhitt says the industry is satisfied.

Mr. TREWHITT: Whereas 10 years ago, we were clearly lagging behind the Europeans quite often in drug approvals, that's not the case today. Today, we are as efficient as the Europeans, and in some cases we are more efficient.

SILBERNER: But the FDA's Woodcock says that efficiency has a cost.

Dr. WOODCOCK: Our patients are now exposed to drugs before other patients around the world are, and therefore we're finding things in our populations that used to be found first in Europe or Australia or Canada because they approved the drugs first.

SILBERNER: Critics say it's a lot worse than that.

Dr. SIDNEY WOLFE (Director, Health Division, Public Citizen): We believe that it's a very dangerously failed experiment in public policy.

SILBERNER: Dr. Sidney Wolfe directs the health division of the advocacy group Public Citizen. He points to the anti-cholesterol drug Baycol, approved in 1997 and withdrawn last year after 31 people taking it died. And there were other problems after passage of the User Fee Act, also known as PDUFA.

Dr. WOLFE: I looked at all the drugs that had come on the market between 1970 and '92 and then were taken off the market. And there were nine drugs in essentially 23 years, as opposed to 10 drugs in just nine years post-PDUFA. The number if close to three times higher per year if you want to look at it that way.

SILBERNER: The industry's response if the percentage of drugs withdrawn stayed the same. Wolfe also says the User Fee Act has created a sense among FDA employees that they're working for industry instead of the public.

Dr. WOLFE: Whereas, in the old system where the funding was coming directly from the US Treasury, an FDA doctor and their supervisor might have said, 'OK, let's wait a minute and let's check this out more carefully,' and in the process might have said no to the drug. Now there are various deadlines, there are various expectations, both implicit and explicit.

SILBERNER: The law setting up the user fee system expires at the end of September. Congress, the FDA and the pharmaceutical industry are all working hard on a renewal plan. The FDA's Woodcock is hoping the new legislation will fix some problems caused by the original user fee program.

Dr. WOODCOCK: Money had to be pulled from other parts of the drug review process to meet the demands of the user fee program, but primarily our reviewers and our scientific staff are working excessively long hours, giving up training, giving up professional development to get the job done.

SILBERNER: She'd like the new deal to include higher fees and fewer restrictions on how those fees could be used and more power to control drugs after they reach the market. Critics of user fees aren't likely to get much chance to voice their opinions. At the moment, the legislation to renew the User Fee Act is slated to be attached to another unrelated bill. The tactic sidesteps the legislative process, limiting debate on the details of the bill and blocking any changes to the wording. Joanne Silberner, NPR News, Washington.