Michigan Attorney General Dana Nessel has announced that the Michigan Department of Attorney General is joining a coalition of 11 other states in a new federal lawsuit out of Washington where plaintiffs are motioning for a preliminary injunction to preserve access to the reproductive healthcare medication mifepristone.
The coalition requests that the court enjoin the FDA from applying an undue Risk Evaluation and Mitigation Strategy (REMS) process to patients requiring mifepristone, or from hindering the availability of mifepristone either by removing the drug from the market or by any other cause.
The coalition argues that lack of such action will risk uncompensable 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.”
Given that mifepristone passed through the FDA’s rigorous approval process in 2000 and has exhibited no significant issues with its over 5.6 million users in the 23 intervening years, the coalition argues that the FDA’s imposition of REMS requirements for the drug is “both arbitrary and unconstitutional.” REMS standards have historically been applied to dangerous or addictive substances for which it is “necessary to ensure that the benefits of the drug outweigh the risks of the drug.” 21 U.S.C. § 355-1(a)(1). Mifepristone is considered statistically safer than many common over-the-counter medications, such as Tylenol and aspirin.
The procedural requirements of REMS classification impose a burden on states, providers, pharmacies, and patients which serves no real medical purpose. In addition to the cost of procedural abortion care when compared to the cost of medication, states also stand to suffer from increased administrative fees and the loss of federal funding.
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.”
A hearing has not yet been scheduled on this matter.
Joining Nessel in the lawsuit are the States of Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, New Mexico, Nevada, Rhode Island, and Vermont.
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