FDA panel finds mifepristone safe and effective

Area of Science:

• Reproductive Health
• Pharmacology

Background:

• Mifepristone, also known as RU486, is an abortifacient drug used in early pregnancy termination.
• The Population Council filed an application for US marketing approval of mifepristone.

Purpose of the Study:

• To evaluate the safety and efficacy of mifepristone for early pregnancy termination.
• To determine if mifepristone should be approved for marketing in the United States.

Main Methods:

• Review of data from a French study and an American clinical trial involving over 2000 women.
• Public testimony from 33 speakers during an FDA Advisory Committee hearing.

Main Results:

• The FDA's Advisory Committee for Reproductive Health Drugs voted unanimously that mifepristone is safe and effective for early pregnancy abortions.
• The committee recommended the drug's approval for marketing in the US, with benefits outweighing risks.

Conclusions:

• The advisory panel's recommendation for mifepristone approval is highly likely to be followed by the FDA.
• Mifepristone, if approved, will be manufactured and distributed in the US, with a company designated as the exclusive distributor.