Critics: FDA Failing to Protect Americans
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.
"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.
Just this week, the FDA responded to two Freedom of Information Act requests and released an internal survey of 400 FDA scientists, conducted in 2002 by the Health and Human Services Department's inspector general. Two-thirds said they were not completely confident that the FDA adequately monitors the safety of drugs after they are approved for sale.
"The survey results confirm that FDA is more interested in taking care of its business clients than it is the American people it's supposed to protect," said David Graham, an FDA drug safety researcher who has been at the agency for 20 years.
Congress will not be back in business until January, but it already has jumped into the act. House Energy and Commerce Committee chairman Joe Barton, R-Texas, and Rep. John D. Dingell, D-Mich., the top Democrat on the panel, have asked Celebrex's maker, Pfizer Inc., for all safety-related records concerning the drug. In addition, Grassley said he plans to introduce legislation making the FDA's drug safety office independent from the new drug approval office.