NCPA - National Center for Policy Analysis

The FDA'S Dangerous Play-It-Safe Attitude

February 1, 2011

The Food and Drug Administration (FDA) is notorious for making the approval of new drugs ever more expensive -- with nothing to show in efficacy and safety.  But this play-it-safe attitude is creating a devastating and potentially far more deadly impact: The pipeline for new antibiotics is drying up, says Steve Forbes, Forbes Magazine's editor-in-chief.

  • Since the 1940s the miracle of penicillin and its relatives has saved tens of millions of lives.
  • Antibiotics easily conquered such illnesses as pneumonia and tuberculosis, which routinely killed countless numbers of people each year.
  • Now, however, the flow of new stuff has dried to a trickle.

Many reasons are being bandied about for the dearth of new drugs:  Research is becoming more expensive, thus pharmaceutical companies are finding the cost/benefit risks too high; we are overusing antibiotics, thereby reducing their potency too quickly.  However, the chief villain is the FDA, says Forbes.

  • Author David M. Shlaes says, "Regulatory agencies like the FDA are contributing to the problem with a constant barrage of clinical trial requirements that make it harder, slower and more costly to develop antibiotics."
  • The FDA, for instance, will capriciously change its rules in the middle of an expensive clinical trial, suddenly telling a company that it must add thousands of new patients to the tests.
  • Even when trials are successfully completed the FDA is reluctant to give a new drug the green light.

Normally if big companies cannot respond to an opportunity or a need entrepreneurial startups will leap in.  But small companies are even more disadvantaged by the FDA's increasingly horrific bureaucratic roadblocks, says Forbes.

Source:  Steve Forbes, "How the FDA may Kill Millions of Us," Forbes Magazine, February 2011.

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