NCPA - National Center for Policy Analysis


October 11, 2007

Since coming under fire in the wake of recent high-profile drug safety issues, the Food and Drug Administration (FDA) is approving drugs too slowly and rejecting many promising new treatments; a death sentence for many patients, say Gregory Conko, a senior fellow, and Erin Wildermuth a research associate, at the Competitive Enterprise Institute.

Consider Provenge, a drug that works like a vaccine to help a patient's immune system fight off prostate cancer:

  • A panel of cancer experts that advises the FDA on new drug approvals unanimously agreed that Provenge was safe, yet the agency demanded additional testing before it would approve the drug.
  • The FDA's main concern is that Provenge may not be effective enough; in one trial, 34 percent of patients receiving the drug were alive three years after treatment, compared to just 11 percent of patients receiving the placebo.
  • But the median survival time for those taking Provenge was just 4½ months longer than for the placebo group.
  • Still, Taxotere, the only currently approved alternative for advanced prostate cancer, extends survival for just half that time.

Further, longer agency reviews don't improve drug safety, say Conko and Wildermuth.  One study by economists from the University of Chicago, the Massachusetts Institute of Technology, Biogen Idec Inc. and Westfield Capital concluded that faster approvals beginning in the 1990s benefited patients with an extra 180,000 to 310,000 years of life -- roughly 3 to 5 times greater than the worst case estimate of harms.

Those figures only scratch the surface of the vast human cost of needlessly delaying drug approvals and keeping others off the market.  The Abigail Alliance for Better Access to Developmental Drugs estimates "the government may have contributed to a million premature deaths by delaying 12 cancer drugs in recent years."

Source: Gregory Conko and Erin Wildermuth, "Drug review drag," Washington Times, October 10, 2007.


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