WASHINGTON -- The record number of drug recalls in the United
States in the past year probably won't slow down approvals for new
American Home Products decided last month to remove Duract, a pain
reliever, from pharmacy shelves less than a year after it was
introduced, due to toxic effects on the liver that may have played a
role in four deaths. It was the sixth withdrawal of a drug due to
safety concerns in the last 12 months, after only 10 between 1980 and
The recalls put pressure on the U.S. Food and Drug Administration.
Congress last year told the agency to accelerate its approval
process. Now, critics of the FDA worry that there will be more cases
like Duract and claim that the agency, which approved 92 new drugs in
the past two years compared to about 25 annually in the past, doesn't
screen new drugs carefully enough.
"We're going to see a lot more of this," said Raymond Woosley,
chairman of the pharmacology department at Georgetown University.
"When we're doubling the number of new drugs approved every year,
there will be problems that will show up."
The FDA and its supporters counter that many side effects are so
rare they don't emerge in clinical trials, no matter how thorough
they are. Also, new drugs may interact with other therapies in
unforeseen ways. This underscores the need to monitor drugs closely
once they go on sale.
The number of drug withdrawals actually proves that the monitoring
system works, they claim.
"A recall isn't a sign that anybody made a mistake, it's a sign
that there's increased scientific knowledge about a product," said
Richard Samp, general counsel for The Washington Legal Foundation and
a sometimes ardent FDA critic.
Common sense suggests that if more new drugs are approved, more
will be recalled. A side effect that only occurs in about 1 in
10,000 patients will sometimes be missed in clinical studies.
"It isn't like the FDA has been asleep at the switch all these
years," said Ira Loss, an analyst who covers the FDA for HSBC
Washington Analysis, a division of HSBC Securities.
The agency has identified dangerous risks from some blockbuster
drugs, such as Warner-Lambert's diabetes drug Rezulin, Johnson &
Johnson's heartburn drug Propulsid and potent HIV treatments made by
Agouron Pharmaceuticals, Merck, Abbott Laboratories and Roche
The benefits of those drugs are so powerful, however, the agency
chose to strengthen their warning labels to highlight concerns rather
than pull them off the market entirely.
"For serious and life-threatening illnesses, we're willing to take
a higher safety risk," said Murray Lumpkin, deputy director of the
FDA's Center for Drug Evaluation and Research.
The FDA's critics complained for years that other countries had
access to new therapies first.
In the past, many drugs were on the market in Europe and elsewhere
before winning approval in the United States. …