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Survey: Cancer Doctors Say FDA Takes Too Long to Approve Drugs
Daily Policy Digest

Regulatory Issues / FDA Drug Approval

Tuesday, May 14, 2002
A survey of cancer specialists sponsored by the Competitive Enterprise Institute revealed that doctors fault the Food and Drug Administration for dragging its feet on approval of potentially life-saving drugs.

  • Some 44 percent agreed that "on balance" FDA regulations "prevent" them from "using promising new drugs and medical devices" to treat patients.
  • Slightly fewer, 43 percent, say FDA rules "help."
  • "The FDA is too slow in approving new medical drugs and devices" say 61 percent of oncologists, and 60 percent agree that "the additional time it takes for the FDA approve medical drugs and devices cost lives by forcing people to go without potentially beneficial therapies."
  • More than two-thirds of oncologists favor changing FDA law "so that unapproved drugs or devices could be made available to physicians as long as they carried a warning about their unapproved status."
A debate has emerged around the question of whether the FDA should restrict its role to certifying a drug's safety -- and leave the evaluation of its effectiveness to medical professionals. But observers report the bureaucracy has signaled it wants even more stringent efficacy tests before a drug is approved for marketing.

Source: Editorial, "Cancer Doctors on the FDA," Wall Street Journal, May 14, 2002.

For more on FDA Drug Approval
http://www.ncpa.org/iss/reg


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