NCPA - National Center for Policy Analysis

Off-label Prescriptions Call Fda Role Into Question

April 16, 2002

The problem of "drug lag" is widely recognized. It requires almost nine years for the Food and Drug Administration (FDA) to approve a new drug in the United States. However, "off-label" use is a good illustration of a less-regulated market in drugs. Off-label refers to the use by doctors of FDA-approved drugs for purposes other than those approved by the agency. Off-label use is so high that most hospital inpatients receive at least one approved drug for reasons other than those for which it was approved.

Through the use of off-label prescriptions, doctors successfully determine the efficacy of drugs on their own and build up a community of knowledge. For example:

  • Aspirin, used for decades as a pain reliever, was also used to reduce the mortality rate among heart attack victims for years before the FDA sanctioned its use for that purpose.
  • Doctors tested the theory that stomach ulcers were caused by bacteria through off-label prescriptions for antibiotics.
  • Mitomycin, approved for gastric and pancreatic cancers, was found to be useful in treating lung, bladder, breast and cervical cancers as well.

Although doctors have the freedom to prescribe old drugs in new ways, the FDA does not allow doctors the same freedom to prescribe new, but not yet unapproved drugs. By circumventing the FDA, off-label prescribing allows for the more adept use of medication. Allowing more experimentation might allow newer and more affordable drugs to reach patients faster and be better suited to their medical needs.

Source: Scott Esposito, "Off-Label Prescribing of Drugs Calls FDA Role into Question," Medical Sentinel, Spring 2002, American Association of Physicians and Surgeons.


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