- Abortion clinics in Virginia, Montana and Kansas filed a lawsuit Monday in U.S. District Court asking a judge to protect access to the abortion pill mifepristone and remove additional restrictions set by the Food and Drug Administration that plaintiffs called “medically baseless.”
- The lawsuit comes as availability of mifepristone, the most common method of abortion in the country, has been threatened in recent weeks by a Texas judge’s April ruling invalidating FDA approval of the drug. On April 21, the Supreme Court stayed that decision, allowing mifepristone to remain on the market for the time being as the case worked its way through an appeals court.
- The plaintiffs want to remove FDA restrictions on mifepristone that are used for drugs with notable side effects, like some used to treat cancer or opioid-based painkillers. The clinics argue the restrictions are discriminatory and unwarranted, and make mifepristone harder for patients to access.
More than 13 states have banned or severely restricted abortion since the Supreme Court ruled to overturn Roe v. Wade last year, nullifying federal abortion protections. The Texas ruling in April threatened to curtail national access to medication abortions.
Central to the plaintiffs’ request include what the lawsuit calls “extremely unusual” FDA safety strategies imposed on mifepristone, which were implemented, and modified, since the drug’s 2000 approval. The safety strategies impose barriers to mifepristone’s access, according to the lawsuit, and are usually only reserved for drugs with serious side effects.
Barriers from the safety strategies include in-person dispensing requirements (which were suspended during the COVID-19 pandemic and permanently removed in 2023), patient agreements that require prescribers and patients to sign a form notifying risks and prescriber certification requirements.
Plaintiffs argue mifepristone has “never come close to meeting” the criteria for drugs requiring the safety standards, and that the FDA itself has repeatedly said that serious adverse events for patients taking mifepristone are especially rare.
Two of the safety barriers applied to mifepristone only apply to 56 out of more than 20,000 drugs marketed in the U.S. and approved by the FDA, according to the lawsuit.
Although in-person dispensing and physician prescriber requirements were later modified, recent litigation threatens to reimpose prior restrictions on mifepristone, including the U.S. Fifth Circuit Court of Appeals’ decision in April to reduce the period of pregnancy when the drug could be taken and eliminating the ability to dispense it by mail.
The Supreme Court, when later ruling to allow mifepristone to remain on the market, also returned the case to the Fifth Circuit.
Plaintiffs argued current FDA-required safety standards, including patient agreement forms and the potential of reimposed safety requirements would “gravely harm” the plaintiffs’ abortion clinics and patients seeking care.
The lawsuit seeks to remove the safety restrictions on mifepristone or, alternatively, prevent further altering of mifepristone’s access.
The plaintiffs, which include Virginia-based nonprofit Whole Woman’s Health Alliance, Missoula, Montana-based Blue Mountain Clinic and Kansas-based clinic operator Trust Women, argue clinics rely on medication abortion to provide care to patients living in states with abortion bans and those who live in rural areas with limited healthcare access.
Recent dueling court decisions regarding mifepristone have caught abortion providers “in the middle of this maelstrom,” according to the lawsuit.
“Plaintiffs cannot retool their practices overnight with no notice — healthcare has no on/off switch,” the lawsuit alleges. “They and their patients require clarity around their continued provision of mifepristone.”