Critics: FDA Failing to Protect Americans
Drug Controversies Over Celebrex, Vioxx Fuel Criticism of Agency
By JOHN YANG
WASHINGTON, Dec. 18, 2004 — It has not been a good year
for the Food and Drug Administration — with a controversy
over the use of antidepressants by children and adolescents, the
withdrawal of breakthrough arthritis drug Vioxx, and now safety
concerns about another widely used pain reliever, Celebrex.
Critics say the agency is failing in one of its most basic tasks — protecting
Americans from dangerous medications, both before and after they
go to market.
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"We expect the FDA to not put a drug on the market that's
not safe," says
Sen. Chuck Grassley, R-Iowa. "And you can't compromise safety,
regardless of how much pressure there is to get more drugs on the
market."
Too Cozy?
Many critics say the FDA office that reviews new drugs is too
cozy with the pharmaceutical industry. They blame a 12-year-old
law that requires drug makers to pay the FDA for the pre-marketing
review process.
"When the industry has over the years spent a couple hundred
million of dollars in cash directly to the FDA to help them along,
the FDA must feel obligated to help the industry along," says
Dr. Sidney Wolfe director the Health Research Group at Public Citizen,
a group associated with Ralph Nader. The group lists drugs it considers
unsafe on a Web site, www.worstpills.org.
The idea behind the law, called the Prescription Drug User Fee
Act, was to speed drug approval without spending more tax dollars.
Dr. David Kessler, who headed the FDA under presidents Bush and
Clinton, says that's fine for one-of-a-kind, breakthrough drugs
intended to treat life-threatening conditions. Now, he says, routine
drug reviews may be moving too fast.
"For drugs for common ailments, drugs widely prescribed,
drugs that are advertised, there is no doubt that we need to study
those drugs more thoroughly," says Kessler, now dean of the
medical school at the University of California, San Francisco.
Post-Approval Snags
Critics say problems continue after a drug is approved for sale.
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