On Friday evening, federal judge Matthew Kacsmaryk issued a ruling to stay the FDA’s approval of mifepristone, part of the regimen of medication abortion care, ordering the decision to take effect seven days after the ruling (which means for now, medication abortion with mifepristone is still protected).
In response, The Century Foundation’s Deputy Director of Health Care Equity and Reform, Anna Bernstein, issued the following statement:
“Friday’s decision in Texas illustrates the continued onslaught on reproductive autonomy that has escalated since the overturning of Roe v. Wade last June. This case—in which conservative extremists cherry-picked a radical Trump-appointed judge, Matthew Kacsmaryk—challenged the Food and Drug Administration’s (FDA) approval of mifepristone in 2000. Mifepristone is the medication that, coupled with misoprostol, makes up the most common regimen for medication abortion care.
“Claims that the FDA misused protocols when approving the drug have already been determined baseless, as a 2018 GAO report thoroughly details. The lawsuit also leans heavily on false claims of the medication’s risks, and this ruling doubles down on that inaccurate and dangerous framing. This is despite the well-established fact that mifepristone is overwhelmingly safe and effective. Indeed, evidence from its twenty-plus years on the market in the U.S. has demonstrated that mifepristone is safer than Tylenol.
“Unlike the Dobbs decision, which led to abortion access fracturing state-by-state, this radical ruling has the potential for nationwide impact. If this decision is allowed to take effect, mifepristone will be made unavailable across the country, including in states that have served as havens for abortion access during the last eight months. The impact would be catastrophic: currently, medication abortion comprises over half of all abortions in the U.S., and mifepristone is part of the gold standard of that care.
“Crucially, this ruling is not the end of litigation around mifepristone. The Biden-Harris administration has already announced that the Justice Department will appeal. And a separate case filed by Democratic state attorneys general in federal court in Washington state also released a ruling Friday night, which directly contradicts that of Kacsmaryk and orders the FDA to maintain the current availability of mifepristone. While it is too early to tell the impact of these conflicting rulings, the two cases could eventually be considered together by the Supreme Court.
“Ultimately, this decision underscores the urgent need for the Biden-Harris administration to explore all possible avenues—and do whatever it takes—to protect and expand abortion access, including access to medication abortion care with mifepristone.”