Policy Documents

Making Drugs Safe and Available without the FDA - Executive Summary

Noel D. Campbell –
January 1, 1997

In summary, this article discusses the lengthy delay of the drug approval process within the U.S. imposed by the FDA that can take up to 12 years before being approved, with critics also citing the FDA for being too slow, too expensive and too restrictive.  There is widespread agreement that reforms are needed to improve efficiency and availability in a timely fashion. So much so, that Congress is considering substantial reforms that would include the European system when it comes to a drug and medical device approval system thereby leaving the FDA bureaucrats in control.