(Washington, D.C.): On September 30, the Food and Drug Administration (FDA) approved the drug application by Evita Solutions, LLC for generic mifepristone, the first drug in the life-ending chemical abortion regimen. Mifepristone blocks the pregnancy support system, specifically the hormone progesterone, thereby starving the unborn child of nutrients needed to survive.
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While the full extent of the originally applied safeguards has been heavily stripped by politically motivated regulatory overreach, this approval stipulates a requirement to follow the same Risk Evaluation and Mitigation Strategies (REMS) as Mifeprex, the brand name for mifepristone manufactured by Danco Laboratories, as approved by the FDA in September 2000.
The approval comes on the heels of the Ethics and Public Policy Center’s analysis of health claims data showing the chemical abortion regimen, including Mifepristone, results in more than 1 in 10 women experiencing at least one serious adverse event. This is more than 22 times the rate reported by the clinical trials supporting the original FDA approval.
John Mize, the CEO of Americans United for Life (AUL), commented on the FDA’s announcement: “Americans United for Life is deeply disappointed and concerned at the decision by the FDA, especially considering data highlighting the increased complication rate for women ingesting the medication without physician oversight or even the original REMS required for medications that provide potential risks.”
Steven H. Aden, Chief Legal Officer and General Counsel for AUL, emphasized, “Political interference has allowed basic safety standards that would ordinarily apply to any other drug proven as dangerous as mifepristone to be stripped over time. If the FDA is going to approve yet another version of this dangerous drug, they must, at minimum, reapply the original REMS protocol. The FDA must uphold its duty to ensure the health and lives of women are not put at risk by this ill-advised approval.”
Read the FDA approval letter here.
For more information or to arrange an interview with AUL, contact Gavin Oxley at press@aul.org or 202-987-3321.
Since 1971, Americans United for Life (AUL) has advanced the human right to life in culture, law, and policy by equipping advocates and lawmakers with the facts and strategies that change hearts and minds and protect human life. The first national pro-life organization in the country, AUL is a nonprofit, public-interest law and policy organization with a four-star rating from Charity Navigator.
