FDA Stakes Claim for Top Drug-Approval Honors

Washington--Responding to critics who say his agency lags behind certain other developed nations in allowing new drugs on the market, U.S. Food and Drug Administration (FDA) Administrator David Kessler and several staff members argue in tomorrow's issue of the Journal of the American Medical Association that the United States outpaces Germany and Japan in drug approvals and compares well with the United Kingdom.

Over the last decade, critics ranging from members of Congress to industry lobby groups have lambasted FDA for lengthy drug-approval times, saying that other developed countries are getting drugs to the market faster. But an analysis of all 214 drugs introduced to the world market from January 1990 through December 1994 belies the claims, Kessler's group says. For instance, out of 44 drugs approved in both the United States and Germany, the United States was first in 31 cases, with approval coming on average 17.9 months faster than in Germany. The outcome of a U.S.-Japan match-up was similar, while a U.S.-U.K. comparison was a toss-up. The bottom line, Kessler argues, is that the findings "clearly support the conclusion that the FDA's standards do not delay consumer access to safe and effective drugs."

Agency critics acknowledge that FDA is speedier at approving drugs than it was in the past. However, comparing drug approval times "is a fake issue, a straw man," asserts Stanford University policy analyst Henry Miller, an outspoken FDA critic and former agency staffer. Miller says that the real problem lies in FDA regulations that lengthen the process of drug development, now estimated to take an average of 10 years and cost $500 million per drug. Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, agrees, saying in a statement today that "streamlining FDA procedures could get safe and effective drugs to patients sooner." That's likely to be at the forefront of FDA reform efforts in Congress early next year.

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