Maine Joins FDA Lawsuit Over Restrictions on Medication Abortion Drug


Mifepristone is Safer Than Tylenol.

Attorney General Aaron Frey has joined a    multistate federal lawsuit against the Food & Drug Administation (FDA) accusing it of singling out one of the two drugs used for medication abortions for excessively burdensome reglation, despite ample evidence that the drug is safer than Tylenol according to a press release from his office this afternoon.

The lawsuit, led by Washington attorney general Bob Ferguson and Oregon attorney general Ellen F. Rosenblum, was filed originally on February 23, 2023 in the US Disrict Court for the Eastern District of Washington.  The original complaint included 12 states; today’s amended complaint adds 6 states or parties, including Maine.  The attorneys general also filed a preliminary injunction asking the court to halt the enforcement of the FDA’s restrictions on mifepristone while the case continues. The other states or parties added to the amended complaint today are:  the District of Columbia, Hawaii, Maryland, Minnesota and Pennslvania.

Of the more than 20,000 drugs approved by the FDA, only 60, including mifepristone, fall under a unique set of restrictions known as Risk Evalulation & Mitigation Strategies, or REMS.  REMS restrictions ae suppoed to apply to inherently dangerous drugs, including opioids like fentanyl, and high-dose sedatives used by psychiaric patients, among others.

The lawsuit asserts the restrictions on prescribing and dispensing mifepristone are unduly burdensome, harmful and unnecesary, and expose providers and patients to unnecessary privacy and safety risks.  The risks are excerbated by the growing criminalization and penalization of abortions around the country in the wake of the US Supreme Court’s decsion in Dobbs v. Jackson Women’s Health.  The Dobbs case overturned nearly a half-century of precedent, eliminating constitutional right to abortion recognized by the court’s Roe v. Wade decision.

The FDA approved mifepristone for use in the US in combination with misoprostal for medication abortions in 2000.  Before its approval in the US, mifepristone was widely used in Europe, beginning in France in the late 1980s.  Since its FDA approval, mifepristone has been safely used in the US  more than 5 million times.

Today’s 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 asks the court to find the FDA’s REMS restrictions unlawful and to bar the federal agency from  enforcing or applying them to mifepristone.  It also seeks to ensure that mifepristone remains accessible, as a safe and effective drug commonly relied upon by residents of the plaintiff states.

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

The following is a quote from a “New York Times” article on Saturday, February 25, 2023 by Pam Bullock, in the first section,  on the original lawsuit:  “A federal judge in Texas is expected to issue an order soon in a case filed by anti-abortion groups to overturn the FDA’s approval of the same abortion pill, mifepristone, and have it taken off the market.  The potential consequences of the Texas case have set the reproductive health comnunity on edge out of concern that the judge, a Trump appointee who is politically conservative and wrote an article that was critical of Roe v. Wade, could issue an order effectvely blocking access to mifepristone across the country.  Such a  ruling would immediately be appealed, but if it ultimately stands, it would have far-reaching implications, affecting states where abortion is legal, not just states where abortion is restricted.”  The same article also points out that the original dozen states filing the lawsuit last month were all “Democratic-controlled states.”