Louisiana v. FDA

Mifepristone is a safe and effective medication used in nearly two-thirds of U.S. abortions, as well as for miscarriage care.  In 2023, the Food and Drug Administration changed the Risk Evaluation and Mitigation Strategy (“REMS”) for mifepristone, permanently removing the outdated in-person dispensing requirement and allowing mifepristone to be dispensed by mail and through certified pharmacies, increasing access to this important medication.

Louisiana and a Louisiana-state resident have asked a federal judge in the Western District of Louisiana to stay or enjoin the Food and Drug Administration’s 2023 Risk Evaluation and Mitigation Strategy (“REMS”) for mifepristone. This request for extraordinary nationwide relief would reimpose medically unnecessary restrictions on a medication that has been safely used by more than 7.5 million people in the United States over more than twenty-five years. Their request relies on discredited data, methodologically flawed studies, and isolated anecdotes that have already been rejected by other courts and the broader scientific community.

The Lawyering Project signed on to an amicus brief which details the benefits mifepristone provides—including when prescribed via telehealth—and the severe consequences that would follow if Plaintiffs obtain the relief they seek.  The brief was filed on behalf of more than 100 reproductive health, rights, and justice organizations, along with other organizations deeply invested in access to reproductive care.  The Lawyering Project also served as local counsel for the primary counsel at Jenner & Block.

The overwhelming consensus of the scientific and medical communities is clear: medication abortion using mifepristone—including when prescribed via telehealth—is safe, effective, and medically necessary. Since the FDA approved mifepristone in 2000, hundreds of high-quality studies and the experience of millions of patients have confirmed its exceptional safety record.

The evidence supporting telehealth access has only grown stronger. Reinstating the in-person dispensing requirement would impose devastating and medically unjustified burdens on patients nationwide. Telehealth access is particularly critical for people in rural areas, low-income communities, communities of color, and survivors of intimate partner violence—groups that already face the steepest barriers to in-person care.

Even individuals in states where abortion remains legally protected could experience delays or be unable to access this essential medication if the Plaintiffs prevail. The requested injunction would undermine access to both abortion and miscarriage care, threatening patients’ health and autonomy across the country.

The brief was part of a suite of amicus briefs filed from a range of experts including the American College of Obstetricians and Gynecologists and other medication associations; nine former FDA Commissioners; the National Domestic Violence Hotline; and disability rights advocates.  They all urged the court to deny this attempt to make it harder for people around the country to get medication abortion and miscarriage care.