Last week, Michigan Attorney General (AG) Dana Nessel announced plans to join a coalition of states in a lawsuit seeking a preliminary injunction to preserve access to mifepristone, a pill used to cause an abortion during the early part of a pregnancy.
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Mifepristone blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifepristone is used together with another medication called misoprostol, which causes an end to pregnancy up to the tenth week of a pregnancy.
Previously, mifepristone could only be obtained in person and needed to be prescribed by physicians. However, during the pandemic, the US Food and Drug Administration (FDA) lifted this restriction and allowed physicians to prescribe the drug online and have it mailed to patients or sent to local pharmacies for pick up.
More recently, the FDA announced a new rule in January dealing with mifepristone, which tightens regulation of the medication and sets forth new requirements that must be followed to obtain it. The FDA is labeling this rule under their risk evaluation and mitigation strategy (REMS), and creating a new program specifically for mifepristone, known as the Mifepristone REMS Program.
Under the program, the drug must be dispensed by certified pharmacies or under the supervision of a certified prescriber, and must be prescribed by a provider that meets certain qualifications. Healthcare providers who prescribe mifepristone, pharmacists who dispense it, and patients who take it are required to sign agreement forms in order to prescribe/take the drug.
The lawsuit challenges the FDA’s new rule modifying the pharmacy certification requirement. The coalition argues that lack of such action will risk non-compensable monetary and labor costs to the states, as well as harming “the health and well-being of state patients and providers by aggravating the ongoing crisis of reduced access to abortion care.” The coalition also believes there is no medical purpose for the rule change, and it only imposes undue burdens on states, providers, pharmacies, and patients.
The coalition consists of 11 states including Arizona, Colorado, Connecticut, Delaware, Illinois, Nevada, New Mexico, Michigan, Rhode Island, Vermont, and Washington. The lawsuit is being co-led by Washington’s AG Bob Ferguson (D) and Oregon’s AG Ellen Rosenblum (D). The coalition argues that “reductions in health care access—and the negative patient outcomes that result—are precisely the sorts of irreparable harms that preliminary injunctions are appropriate to prevent.”
“This is just one example of the unprecedented threats to reproductive healthcare being faced by women across our country in the wake of Dobbs,” Nessel said. “Mifepristone has been in use for over two decades without issue, but anti-choice groups have taken this period of uncertainty as an opportunity to obstruct safe and legal medical care—regardless of the risk it poses to residents’ health and wellbeing. Their actions cannot be allowed to stand.”
Ferguson has filed 110 lawsuits against presidential administrations of both Democratic and Republican presidents, of which he has only lost three. The lawsuit was filed in the US District Court for the Eastern District of Washington, and a hearing has yet to be scheduled.