New Evidence Against RU-486 Filed by Concerned Women for America

WASHIGNTON, October 14, 2003 (LifeSiteNews.com) – In the wake of 18-year old Holly Patterson’s death after taking the abortion drug RU-486, Concerned Women for America, with two doctors’ groups, filed a second legal document on Oct. 10 supporting the case for the FDA to withdraw its approval of the dangerous drug.  This document responds to the attempt by Danco, the distributor of RU-486 (brand name is Mifeprex), to rebut the medical, scientific and legal arguments presented by Concerned Women for America (CWA), American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) and Christian Medical Association (CMA) in a Citizen Petition filed in August 2002.  It bolsters the Citizen Petition’s thoroughly researched evidence that:  – The clinical trials for RU-486 were legally and clinically substandard.  – The inclusion of the second drug, misoprostol, in the protocol was unlawful.  –  The use of RU-486 and misoprostol (Mifeprex Regimen) is inherently unsafe, as proven by recent life-threatening events and deaths.  – The approval of RU-486 under a special regulation for drugs that treat life-threatening or serious illnesses was unlawful.  – Web sites show that prescribers are not following the FDA’s requirements to ensure patient safety. As the FDA wrote to a Congressman in 2000, “If restrictions are not adhered to, FDA may withdraw approval.”  In its response, Danco failed to produce medical-scientific data or adequate explanations for the evidence presented in the Citizen Petition that the clinical trials were insufficient and underreported serious complications, that the FDA violated regulations intended to ensure the safety of approved drugs, and that prescribing clinics are deliberately ignoring the FDA’s requirements for administering RU-486, thereby put women at great risk   Danco made the astonishing claim that an immediate revocation of the FDA’s approval would violate the Constitution. CWA, AAPLOG and CMA responded that, “Given the situation, the Petitioners are dismayed at the Sponsor’s [Danco] insistence that its ‘property right to produce and market Mifeprex,’ outweighs any concern for the safety of the patients that the Sponsor is seeking to ‘treat.’”“The FDA need not wait any longer for evidence that RU-486 is a dangerous drug. The trials proved it, and the hundreds of American women who have suffered serious complications, even death, prove it. Women should not have to pay with their health or lives so that abortion can be easier for the abortion provider,” stated Wendy Wright, Senior Policy Director for CWA.