Citizen Petition     2/2/2002
Requesting the Withdrawal of FDA's Approval of Mifeprex

Click here or on the image above to read the response to Danco.

A Citizen Petition was filed on August 20, 2002 with the FDA describing the threat to women's health from the abortion drug Mifeprex™ (commonly referred to as RU-486 or mifepristone). The petition also outlined numerous procedural violations that occurred when FDA considered the drug for approval. The Citizen Petition asks the Commissioner of FDA to halt all distribution and marketing of the drug.

Press Release
Executive Summary
Citizen Petition
Bibliography
Petition Statistics

The FDA approval process is intended to ensure that drugs, commercially marketed in the United States, are safe and effective for their intended uses. Violations of the process have, in the recent past, resulted in the great sickness and death for some medical patients using other drugs approved by FDA - and then withdrawn from the market. (For background, The Los Angeles Times has discussed this important topic at great length in December 2000 in a series of stories. )

On April 17, 2002, the FDA released a Letter to Health Care Providers from the manufacturer and posted a webpage of questions and answers related to the drug. These actions were prompted by numerous serious adverse events that occurred from the use of the Mifeprex abortion regimen.

If you have suffered adverse events from the use of Mifeprex, you are not alone - but please make sure that the FDA knows about it. Either your doctor or you can report this occurrence directly to the FDA.

The Petitioners comprise doctors and women concerned about the health and safety of women - here are links to their websites:

• American Association of Pro-Life Obstetricians and Gynecologists
• Christian Medical Association
• Concerned Women for America
• FDA's Subpart H Approval Chart

Links to Related Websites:

• FDA's Mifeprex webpage
• For background - RU486Facts.org
• National Right to Life

Adobe Acrobat: To read the petition, you must use the computer program Adobe Acrobat Reader. It is available free of charge but must be downloaded to your computer.

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