Maine and 17 other states have filed a lawsuit against the US Food and Drug Administration (FDA) in an effort to remove restrictions on mifepristone, a drug that has been used to safely induce abortions since the 1980s. The lawsuit asserts that the FDA exceeded its authority by imposing unnecessary and burdensome restrictions on the drug, which falls under a set of restrictions known as Risk Evaluation & Mitigation Strategies (REMS). These restrictions are intended to apply to inherently dangerous drugs, such as opioids and high-dose sedatives used by psychiatric patients. However, of the more than 20,000 drugs approved by the FDA, mifepristone is one of only 60 that falls under this category of restrictions. The lawsuit claims that the FDA’s actions violate the constitutional guarantees of equal protection.

Mifepristone, also known as RU-486, is used in combination with misoprostol to terminate pregnancies of up to 10 weeks. 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. 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. To prescribe mifepristone, healthcare providers must be specially certified by the drug distributor. Pharmacies must also be certified to dispense mifepristone before they can fill a prescription.

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 safely used by about 5 million women to terminate a pregnancy. However, despite this safety record, mifepristone is subject to a number of restrictions that the lawsuit claims are unnecessary and serve to deter and restrict people who have a right to end a pregnancy through this extremely safe medication.

The lawsuit comes at a time when the right to abortion access is being fought over in courts and legislatures around the country following the US 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. In a related case, Maine Attorney General Aaron Frey has joined 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. 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 US Supreme Court to overturn Roe v. Wade.

The attorneys general are asking the court for a preliminary injunction to halt enforcement of FDA restrictions on mifepristone until the case has been resolved. The plaintiffs argue that the restrictions on mifepristone use 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 following the Supreme Court’s elimination of the constitutional right to abortion.

The preference for using mifepristone in medical abortions is higher in Maine than it is nationally, where two-thirds of all abortions at two of Maine’s largest clinics use mifepristone. With the lawsuit, Maine and the other states seek to remove the unnecessary restrictions on mifepristone, enabling more women to safely and effectively exercise their right to choose.

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