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Jody Clarke, 202.331.2252
Washington, D.C., April 24, 2006—A government report released today says the Food and Drug Administration is too slow in identifying safety problems once drugs are on the market, but FDA policy experts at the Competitive Enterprise Institute believe the more dangerous problem is FDA’s ‘deadly overcaution.’
“The real risk is that FDA will slow down its approval of new therapies in response to this critique, further delaying the availability of important new therapies.” says Sam Kazman, CEI’s general counsel. “The only way to guarantee zero risks from medicines is not to approve any medicines, and that would be a public health disaster.”
Congress requested the Government Accountability Office report on the FDA’s post-approval monitoring of drugs after the popular painkillers Vioxx and Bextra, along with several other drugs, were pulled from the market. The report criticizes FDA for not acting quickly enough when safety concerns arise. However, a February 2005 FDA advisory committee suggested that FDA can act too quickly in withdrawing drugs. It recommended that Vioxx and Bextra be put back on the market because their therapeutic value outweighs the known health risks.
“Even when FDA has good information, deciding when a drug’s risks outweigh its benefits is not easy,” says Gregory Conko, senior fellow at CEI. “The FDA is charged with protecting the health of patients, and part of that responsibility includes getting good drugs to patients and keeping them on the market where they can do some good.”
CEI has conducted five polls of medical specialists regarding the issue of whether the FDA is too fast or too slow in approving new therapies. The specialists—which included oncologists, cardiologists and emergency care physicians—consistently viewed FDA as too slow in its approvals.