Maine and 17 other states are suing the Food and Drug Administration in an effort to eliminate restrictions the federal agency has placed on mifepristone, a drug that has been safely used to induce abortions since the 1980s.

Attorney General Aaron Frey announced Thursday that Maine has joined the multistate lawsuit, which claims the FDA singled out the medication abortion drug by placing unlawful and unnecessary restrictions on its use despite scientific evidence that has shown it to be safer than Tylenol.

“There is no medically justified reason for the higher burden placed on people trying to obtain mifepristone,” Frey said in a statement. “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.”

Frey said that of the more than 20,000 drugs approved by the FDA, mifepristone is one of only 60 that fall under a set of restrictions known as Risk Evaluation & Mitigation Strategies. REMS restrictions are supposed to apply to inherently dangerous drugs, including opioids like fentanyl, and high-dose sedatives used by psychiatric patients, among others.

Though the restrictions on mifepristone use have been in place for years, they were retained after an FDA risk review conducted in January.

The states’ 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 comes as the right to abortion access is being fought over in courts and legislatures around the country following the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health that overturned nearly a half-century of precedent, eliminating the constitutional right to abortion recognized by the court’s Roe v. Wade decision.

The lawsuit was filed Feb. 23 in the U.S. District Court for the Eastern District of Washington. The original complaint named 12 states, but an amended complaint filed Thursday included the District of Columbia, Hawaii, Maine, Maryland, Minnesota and Pennsylvania. In addition, the attorneys general ask the court for a preliminary injunction to halt enforcement of FDA restrictions on mifepristone until the case has been resolved.

In 2000, the FDA approved mifepristone to terminate pregnancies of up to 10 weeks, when used with a second drug, misoprostol. Mifepristone is taken first to dilate the cervix and block the hormone progesterone, which is needed to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel pregnancy tissue. To prescribe mifepristone, health care providers must be specially certified by the drug distributor.

Patients and providers also 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. Pharmacies also must be certified to dispense mifepristone before they can fill a prescription.

In a related case, Frey in February joined his counterparts in 21 other states filing a brief that urges a conservative federal Texas judge known for his anti-abortion views to reject a lawsuit challenging the use of mifepristone.

TEXAS RULING AWAITED

The suit, filed in Texas, seeks to revoke the FDA’s approval of mifepristone, one of two drugs in a prescription used in more than half of all U.S. abortions and the most common method of ending an unwanted pregnancy in Maine. Such a ruling would outlaw the drug in states like Maine, where abortion has remained legal following a Supreme Court ruling last year that allowed states to further restrict abortions.

The Texas case was brought by Alliance Defending Freedom, the same conservative medical group that was behind the Mississippi state abortion law that led the U.S. Supreme Court to overturn Roe v. Wade. The lawsuit alleges the FDA erred when it approved mifepristone for abortion in 2000 through an expedited process that is intended to get medical treatments to ill patients faster. The plaintiffs say this was an improper use of the fast-track approval process because pregnancy is not an illness.

Frey said that Thursday’s 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, Frey said, are exacerbated by the growing criminalization and penalization of abortion around the country in the wake of the Supreme Court’s eliminating the constitutional right to abortion.

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.

In his statement, Frey said the FDA 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.

According to the FDA, not a single death can be attributed to mifepristone during its entire history of use in the United States. It has been used by about 5 million women to terminate a pregnancy.

In Maine, the preference for using mifepristone in medical abortions is higher than it is nationally. Two-thirds of all abortions at two of Maine’s three abortion clinics – Maine Family Planning in Augusta and Planned Parenthood in Portland – are medication abortions. At Mabel Wadsworth Center in Bangor, half the abortions performed are medication procedures.

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