A broad range of experts filed amicus briefs on May 1 urging the Fifth Circuit Court of Appeals to reverse a district court decision that purports to block the FDA’s long-standing approval of mifepristone, the first pill in the two-drug regimen for medication abortion.

The briefs were filed in Alliance for Hippocratic Medicine v. FDA, a case brought by anti-abortion advocates aiming to remove the abortion drug from the market nationwide—even in states where abortion is protected. The case will be argued before the Fifth Circuit on May 17.

Watch the May 17 livestream.

Leading medical and health organizations; pharmaceutical companies; members of Congress; current and former government officials; and reproductive health, rights and justice advocates were among the experts filing amicus briefs (also known as “friend of the court” briefs) with the court.

The briefs argue that the lower court’s decision, if allowed to take effect, would upend the FDA’s scientific-based process for approving drugs; jeopardize other drugs that have been approved by the FDA; harm patient health; and interfere with patient decision-making. Several also outline mifepristone’s proven safety and efficacy since it was first approved more than two decades ago.

Read all the amicus briefs.

Highlights of the briefs include:

• Two briefs from members of the pharmaceutical industry, including Pharmaceutical Research and Manufacturers of America and other pharmaceutical companies, pharmaceutical company executives, and industry investors: These briefs emphasize that Congress intended the FDA, not courts, to serve as the expert arbiter of drug safety and effectiveness; that the district court improperly substituted its own views for FDA’s expert scientific judgement; and that the court’s decision would create impossibly rigid new standards for drug development and approval, which would in turn chill drug development and investment. 

• Members of Congress Amicus Brief: This brief was filed on behalf of 253 Members of Congress, the most ever to join an amicus brief in a reproductive rights-related case. It emphasizes that the challenge to mifepristone has no basis in law, threatens the Congressionally mandated drug approval process, and poses a serious health risk to pregnant individuals by making abortion more difficult to access—when access has already been seriously eroded in the aftermath of the elimination of the constitutional right to abortion by the U.S. Supreme Court in 2022.

• Advanced Practice Clinicians’ Amicus Brief: Filed on behalf of the National Association of Nurse Practitioners in Women’s Health and the American College of Nurse-Midwives, this brief addresses the Court’s attempt to prevent Advanced Practice Clinicians (APCs) from prescribing mifepristone as part of their independent scope of practice. It emphasizes that APCs must satisfy rigorous education and certification requirements, that APCs provide safe and effective abortion care, and that mainstream medical and public health groups overwhelmingly support the provision of medication abortion care by APCs. 

Read more about the case.

• Reproductive Health, Rights and Justice Advocates Amicus Brief: Filed on behalf of over 200 reproductive health, rights, and justice organizations—including the Center for Reproductive Rights—this brief affirms that mifepristone is safe, effective, and widely used, and that the consequences of suspending FDA’s approval of mifepristone will be immediate and severe. These organizations have directly seen the importance of medication abortion to individuals’ health and bodily autonomy. Several organizations represent abortion providers and patients and have experience litigating cases, while others are clinics or healthcare providers who would be directly impacted by the district court’s decision.

For a complete list of amicus briefs submitted in Alliance for Hippocratic Medicine v. FDA, click here.

For more information on the case, including court decisions, legal documents, news updates, and more, click here.