AG Mayes Sues FDA Over Restrictions on Abortion Drug
Attorney General Kris Mayes has joined a multistate federal lawsuit against the Food & Drug Administration (FDA) accusing it of singling out one of the two drugs used for medication abortions for excessively burdensome regulation, despite ample evidence that the drug is safer than Tylenol.
The Lawsuit and Injunction
The lawsuit, led by Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum, was filed in U.S. District Court for the Eastern District of Washington. Oregon, Nevada, Delaware, Illinois, Connecticut, Colorado, Vermont, New Mexico, Michigan and Rhode Island also joined the lawsuit.
Attorney General Mayes said, “Mifepristone is safe and effective and has been used for over two decades by millions of people. Access to this drug allows patients to make their own private medical decisions without interference by the government or anti-abortion politicians. The bottom line is that individuals should be able to make decisions about their reproductive lives without unnecessary restrictions like these.”
The attorneys general also filed a preliminary injunction asking the court to halt the enforcement of the FDA’s restrictions on mifepristone while the case continues.
FDA Restrictions
Of the more than 20,000 drugs approved by the FDA, only 60 – including mifepristone – fall under a unique set of restrictions known as Risk Evaluation & Mitigation Strategies, or REMS, which are supposed to apply to inherently dangerous drugs, including opioids like fentanyl, and high-dose sedatives used by psychiatric patients, among others.
The FDA-approved regimen for medication abortion involves a dose of mifepristone, followed by a second drug, misoprostol. To prescribe mifepristone, health care providers must be specially certified by the drug distributor in advance. To receive the prescription, patients and providers must sign an agreement that certifies the patient has decided to take the drugs to end their pregnancy — regardless of whether they are seeking an abortion or are being treated for a miscarriage, which is another common use for mifepristone. A copy of this agreement must be included in the patient’s medical records. To dispense mifepristone, pharmacies must also be specially certified before they can fill a prescription.
The Lawsuit
The lawsuit asserts the restrictions on prescribing and dispensing mifepristone are unduly burdensome, harmful and unnecessary, and expose providers and patients to unnecessary privacy and safety risks. The risks are exacerbated by the growing criminalization and penalization of abortion around the country in the wake of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health.
Disclosure of a provider’s or pharmacy’s certification to prescribe mifepristone, or a patient’s agreement to receive it, all required by the FDA, could expose them to violence, harassment or abuse. This documentation may also be used to threaten providers or patients with legal liability in states with extreme anti-abortion laws.
The FDA approved mifepristone for use in the United States in combination with misoprostol for medication abortions in 2000. Since its FDA approval, mifepristone has been safely used more than 5 million times in the U.S.
Mifepristone’s Safety Record
The FDA itself has acknowledged that “serious complications have proven to be extremely rare” with mifepristone. In the lawsuit, the attorneys general note that mifepristone is associated with fewer serious side effects and deaths than common drugs like Tylenol or Viagra — neither of which are regulated under REMS restrictions.
According to the FDA, not one single death can be attributed to mifepristone during its entire history of use in the United States.
