AEGiS-AP: FDA Defends Its Drug Program

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

FDA Defends Its Drug Program

The Associated Press - Dec 13, 1995; 50 Rockefeller Plaza, New York, NY 10020.

WASHINGTON (AP) -- Fighting criticism that its red tape hurts American patients, the Food and Drug Administration unveiled a report showing it approves vital new drugs as soon as -- and often faster than -- Europe or Japan.

"If there is a drug lag, it is not in America," FDA Commissioner David Kessler declared Tuesday.

FDA critics are pushing Congress to revamp the agency, contending it takes too long to approve life-saving therapies that are first available overseas.

The FDA acknowledges it needs to speed up, but didn't think it was slower than other countries, so it checked England, Germany and Japan. The FDA reported Tuesday that Americans had access to almost every vital drug sold in those countries, and were spared two products that England had to take off the market.

Among the biggest drugs: Americans got five AIDS drugs before any other country, the ovarian cancer drug Taxol a year earlier than Europeans, the first multiple sclerosis drug 28 months before Europe and the first cystic fibrosis treatment several months before Europe. On Tuesday, the FDA approved the world's first treatment for Lou Gehrig's disease.

Also Tuesday, the FDA issued its annual report to Congress that showed the agency in fiscal 1994 approved 93 percent of all drugs within a year of the companies' applications. Federal law mandates that the FDA approve just 55 percent of drugs in that time.

Critics didn't buy the report.

The Pharmaceutical Research and Manufacturers Association said the FDA approved 150 new drugs between 1990 and 1994, but 60 percent were approved first in some other country, not just the ones the FDA checked. Typically foreign-based companies seek approval at home first.

"Clearly FDA has made significant improvement," said spokesman Jeff Trewhitt. "However, more fundamental reform must be enacted."

And the Competitive Enterprise Institute, a conservative think tank, says patients still had to wait months to buy even drugs the FDA approved first. Congress should allow any drug to be sold here, with just a warning that it's not FDA-approved, so dying patients don't have to wait, said CEI's Sam Kazman.

The FDA pulled drug data from two European publications that track the world market and from the three countries. From January 1990 through December 1994:

--The FDA and England both approved 58 drugs, 30 that were first approved here and 28 approved first in England.

--Of the 44 drugs approved by both the FDA and Germany, Americans got 31 first.

--Of the 14 drugs approved by both the FDA and Japan, Americans got 10 first.

But the main question is whether Americans can buy "priority" drugs to treat diseases that have no other therapy or that are better than existing therapy.

Americans can buy 18 drugs the English can't, and the English can buy 29 drugs Americans can't, the FDA discovered. Of the 18 U.S.-only drugs, nine are "priority" -- including the world's only therapy for Alzheimer's disease.

But only two of 29 English-only were priority -- and both were taken off the market worldwide before ever reaching Americans, the study showed. They were a drug for schizophrenia banned for causing life-threatening aplastic anemia, and a drug for blood infections that was later proved not to work.

The remaining 27 English drugs are almost identical to other medicines sold here, the FDA said.

Germany sells 34 drugs the United States doesn't, and Americans can buy 32 medicines Germans can't. Of Germany's 34, the only one not comparable to a U.S. medicine is a safer whooping cough vaccine. At least two companies are awaiting FDA approval to sell that vaccine here.

Japan sells 82 drugs Americans can't buy, and Americans can buy 62 the Japanese can't. But the vast majority of the Japanese-only drugs are slight variations of medicines already sold worldwide.

Copyright 1995/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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