A coalition of 22 states Friday filed an amicus brief opposing a proposed preliminary injunction that would withdraw or suspend the US Food and Drug Administration’s (FDA) approval of the abortion medications Mifepristone and Mifeprex. The case is in the US District Court for the Northern District of Texas Amarillo Division.
The brief asserts that the medications are safe and effective. Additionally, the brief claims that the drugs help promote access to abortion in rural and underserved communities. The brief states that withdrawing the FDA’s approval of the drugs risks undermining “the integrity of the FDA-approval process for other drugs.”
In response to filing the brief, New York Attorney General Letitia James stated:
Decades of medical and clinical research have proven that medication abortion is safe. Despite these facts and its widespread use, we know this is not a debate about science. Access to safe reproductive healthcare could be in jeopardy for millions of Americans because of a baseless lawsuit. We are taking action to protect the reproductive freedoms of people in every corner of the country, especially in vulnerable communities. Every time they try to chip away at our rights, we will rise up and fight back to protect access to safe abortion care.
The anti-abortion group Alliance for Hippocratic Medicine and other similar groups commenced the lawsuit against the FDA in November 2022. The 113-page complaint argues that the FDA failed to follow its legal obligations to protect girls’ and women’s health, safety, and welfare when it approved the drugs. The plaintiffs then moved for a preliminary injunction that would withdraw or suspend the FDA approval of the drugs. The plaintiffs seek the preliminary injunction because they believe they are “likely to prevail on their claims that the FDA acted unlawfully” when it approved the drugs for medication abortion.
After filing the original complaint on behalf of the Alliance for Hippocratic Medicine, the Alliance Defending Freedom Senior Counsel Erik Baptist stated:
By illegally approving dangerous chemical abortion drugs, FDA officials put women and girls in harm’s way, and now it’s high time they were held accountable for their reckless actions. Science was the FDA’s first victim. Women and girls were soon to follow. We urge the court to listen to the doctors we represent who are seeking to protect women from the documented dangers of chemical abortion drugs.
The FDA responded to the Alliance by stating that reversing the approvals would “dramatically harm” public interest. The FDA also asserted that Mifepristone has “meaningful therapeutic benefit to patients.”
According to the FDA, mifepristone facilitates medication abortion by blocking a hormone called progesterone. When used with another drug, misoprostol, it can be used to terminate a pregnancy within ten weeks of the last menstrual period. The FDA claims approximately 5.6 million women have used the drug with negligible adverse effects.