October 10, 2003

Response filed with FDA to opposition comments of the Population Council and Danco Laboratories regarding the Mifeprex Citizen Petition

Holland, Michigan—Today the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), together with the Christian Medical Association (CMA) and Concerned Women for America (CWA), filed a response with the FDA to claims of the Population Council, Inc., and Danco Laboratories, LLC.

The Population Council holds the U.S. patent on mifepristone and Danco Laboratories distributes mifepristone in the United States under the brand name, Mifeprex. In August 2002, AAPLOG, CMA, and CWA jointly filed a Citizen Petition with the FDA documenting the inadequacies of the approval process for Mifeprex and requesting that Mifeprex be removed from the market while these inadequacies were addressed. The Population Council and Danco Laboratories, subsequently filed comments in opposition to the original petition, demanding status quo for the drug.

The response filed today by AAPLOG, CMA, and CWA address the claims made by the Population Council and Danco Laboratories and demonstrates that they have not considered the serious issues raised by the original Citizen Petition.

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