12 States Sued the FDA to Ease Restrictions for Medication Abortion

On February 24, 2023, 12 states filed a lawsuit against the FDA to ease restrictions enforced for mifepristone, one of two pills required for a medication abortion. This lawsuit addresses concerns that the current Risk Evaluation and Mitigation Strategy (REMS) implemented by the FDA for this medication is too restrictive, considering the medication’s safety profile.

The plaintiffs in the trial include Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont. These states are suing the United States FDA, represented by Commissioner Robert M. Califf, and the Department of Health and Human Services (HHS), represented by Secretary Xavier Becerra.

The current REMS regulations require extensive permission before prescribing mifepristone. Current limitations require the prescriber to be certified under the Mifepristone REMS Program and complete the Prescriber Agreement Form.

The restrictions go beyond the prescriber, forcing pharmacies to get certification before dispensing, complete the Pharmacy Agreement Form, and track packages if shipping prescriptions. Patients are also expected to review and sign the Patient Agreement Form.

The current lawsuit filed by these states argues that these restrictions do not accurately reflect the safety profile of the medication. The complaint states that the “FDA’s decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only ‘exceedingly rare’ adverse events has no basis in science.”

According to the complaint filed, only 60 FDA-approved drugs have a REMS. Among these 60 drugs are dangerous substances such as opioids, risky chemotherapy medications, and sedatives.

The plaintiffs argue that this classification is unnecessary as the medication is highly effective with low complication rates. They note that mifepristone is safer than other less-regulated medications, such as Viagra and Tylenol, sold over the counter.

The states’ lawsuit comes at a time of uncertainty surrounding abortion access and reproductive healthcare. The 2022 ruling by the US Supreme Court overturning Roe v. Wade has left many anxious about abortion access. Many states across the US have enacted laws banning or restricting abortion care, leaving individuals worried about the future of reproductive healthcare.

Beyond the overturning of Roe v. Wade, a Trump-appointed Texas judge threatens national access to abortion medication. The judge is expected to rule on a case by an anti-abortion organization that hopes to have mifepristone taken off the market entirely, meaning overturning the medication’s FDA approval.

While most healthcare organizations maintain that access to abortion care is critical, many predict he will rule in favor of overturning approval based on previous rulings and the judge’s staunch anti-abortion background.

With the Texas case in mind, the 12 plaintiffs against REMS regulations for mifepristone hope to maintain and widen access to medications for abortions which are used in roughly 60% of abortion cases. Until the case is closed, the plaintiffs have filed a motion for a preliminary injunction, removing restrictions on mifepristone prescription until a decision is made.

In a statement to the New York Times, Kristin Beneski, first assistant attorney general for Washington State, said, “We are not arguing that the FDA should not have approval authority over mifepristone, only that the REMS system is unnecessary for this drug and poses unnecessary risks to providers and patient in the current legal landscape. Those risks are real and need to be addressed.”