NCPA - National Center for Policy Analysis

When FDA Approval Isn't Required

December 10, 2001

Most Americans are unaware that some drugs being prescribed by their doctor have never been approved by the Food and Drug Administration. Actually the range and number of these drugs have been described as a small subset of the entire product of the pharmaceuticals industry. In large measure, production and marketing of these drugs have been "grandfathered in" without a requirement for FDA approval.

  • The unapproved prescription drugs include hormone-replacement therapies, prenatal vitamins, and many cough and cold medicines.
  • Most of the drugs are widely accepted by the medical community.
  • They use ingredients that have been on the market for years -- some predating laws on safety and effectiveness enacted 40 years ago.
  • Many of the drugs are on a list to be reviewed by the FDA -- but they are of low priority for the agency.

In this niche market, certain companies create knock-offs of older drugs and market them as generic alternatives without any testing.

Source: Tara Parker-Pope, "Some Prescribed Drugs Slip Onto the Market Without FDA Approval," Wall Street Journal, December 7, 2001.


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