Lawsuit accuses the FDA of ignoring more than a quarter century of science showing that mifepristone is extremely safe
March 9, 2023
AUGUSTA – Attorney General Aaron Frey 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, led by Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen F. Rosenblum, was originally filed on February 23, 2023, in the U.S. District Court for the Eastern District of Washington. The original complaint included twelve states: Oregon, Washington, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont. Today’s amended complaint adds 6 states as parties: the District of Columbia, Hawaii, Maine, Maryland, Minnesota, and Pennsylvania.
“There is no medically justified reason for the higher burden placed on people trying to obtain mifepristone,” said Attorney General Frey. “To inappropriately categorize mifepristone along with other riskier drugs will serve to deter and restrict people who have a right to end a pregnancy through this extremely safe medication.”
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.
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. REMS restrictions 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 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. The Dobbs case overturned nearly a half-century of precedent, eliminating the constitutional right to abortion recognized by the court’s Roe v. Wade decision.
The FDA approved mifepristone for use in the United States in combination with misoprostol for medication abortions in 2000. Before its approval in the U.S., mifepristone was widely used in Europe, beginning in France in the late 1980s. Since its FDA approval, mifepristone has been safely used in the United States more than 5 million times.
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 a single death can be attributed to mifepristone during its entire history of use in the United States.
Today’s lawsuit asserts that the FDA exceeded its authority and acted arbitrarily by continuing its unnecessary and burdensome restrictions on mifepristone. The lawsuit also asserts that the FDA’s actions violate the constitutional guarantees of equal protection.
The lawsuit asks the court to find the FDA’s REMS restrictions unlawful and to bar the federal agency from enforcing or applying them to mifepristone. It also seeks to ensure that mifepristone remains accessible, as a safe and effective drug commonly relied upon by residents of the plaintiff states.
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