Twelve blue states filed a lawsuit Friday against the U.S. Food and Drug Administration (FDA) for placing “burdensome restrictions” on mifepristone, the first of two drugs used in a chemical abortion.
The lawsuit claims that current Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone, which include limits on “who can prescribe and dispense the drug” and documentation of the patient’s use “for the purpose of abortion,” violate the Due Process Clause of the Fifth Amendment. The debate around abortion pills is increasingly prompting legal action from states, lawmakers and advocacy organizations, with nearly every state taking sides in a separate Texas case brought by pro-life medical organizations against the FDA that could overturn the agency’s approval of abortion pills altogether.
“Through the 2023 REMS, FDA reduces access to a critical and time-sensitive health care service needed by pregnant people,” the lawsuit claims. “And FDA treats providers, pharmacists, and patients who prescribe, dispense, or use mifepristone worse than providers, pharmacists, and patients who prescribe, dispense, or use nearly every other medication.”
Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum co-led the lawsuit, which was joined by Oregon, Nevada, Delaware, Arizona, Illinois, Connecticut, Colorado, Vermont, New Mexico, Michigan and Rhode Island.
In a statement, Washington Attorney General Bob Ferguson said the government has “known for years that mifepristone is safe and effective.”
“In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risk,” Ferguson said. “The FDA’s excessive restrictions on this important drug have no basis in medical science.”
“In this time when reproductive healthcare is under attack, our coalition of 12 states seeks to ensure that access to Mifepristone – the predominant method of safe and effective abortion in the US – is not unduly restricted. Our coalition stands by our belief that abortion is healthcare, and healthcare is a human right,” Oregon Attorney General Rosenblum said in a statement.
The current lawsuit in Texas, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), argues that the FDA never had the authority to authorize chemical abortion drugs in the first place, since it did so using accelerated approval regulations that forced it to categorize pregnancy as an “illness.”
Many opponents to abortion pills, like those who filed the suit in Texas, believe FDA regulations of mifepristone are not too tight but too loose, citing concerns about its impact on women’s health.
An amicus brief filed in the Texas case by Human Coalition notes that there have been “1,048 hospitalizations, 604 blood transfusions, and 414 infections (including 71 severe infections)—with a total of 4,213 adverse events” reported after using the pill as of June 2022. Other opponents cite concerns of coercion that could result from dispensing the pill without restrictions.
The FDA did not immediately respond to a request for comment.
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