NCPA - National Center for Policy Analysis

FDA Reforms Apparent, But Progress Is Slow

August 30, 1999

Prodded by Congress and stung by criticisms that its regulatory procedures were allowing people to die while waiting for drugs to be approved, the Food and Drug Administration has made progress over the past several years. Time needed for approvals has fallen. But the development period for drugs and devices is still unconscionably high, critics report.

  • The average approval time for new drugs in 1998 was 11.7 months -- nearly a 20-month drop from a decade earlier.
  • On the other hand, it still takes 15 years to bring a breakthrough medicine to market -- with much of that time taken up on human studies which the FDA controls.
  • Under a law passed in 1992, the FDA will soon have only one month to explain why it would put a company's candidate drug on "clinical hold" -- there having been no deadline in the past.
  • The agency has also worked on a better system for resolving disputes between itself and companies, observers report.

Source: Daniel J. Murphy, "Reform Arrives at FDA, Slowly," Investor's Business Daily, August 30, 1999.


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