A Texas federal judge on Friday ruled that the U.S. Food and Drug Administration "stonewalled judicial review" of its decades-old approval of the abortion drug mifepristone and agreed to stay the effective date of the drug's approval, in a watershed ruling that could dramatically restrict abortion access in the U.S., where medication abortion has become the most common method to terminate pregnancies.
U.S. District Judge Matthew J. Kacsmaryk stopped short of granting the preliminary injunction sought by the anti-abortion advocacy groups against the FDA's 23-year-old approval of mifepristone — the pill used in tandem with misoprostol to end an early-stage pregnancy. The judge agreed "to stay the effective date of FDA's September 28, 2000 approval of mifepristone and all subsequent challenged actions related to that approval."
However, he stayed the applicability of his opinion and order for seven days "to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit."
Almost immediately after the Texas ruling came down, a Washington federal judge issued an order preliminarily enjoining the FDA from "altering the status quo and rights as it relates to the availability of Mifepristone."
Judge Kacsmaryk, who was appointed in 2019 by former President Donald Trump, found that the anti-abortion advocacy groups had a substantial likelihood of success on the merits and stayed the FDA's 2000 approval while a lawsuit brought against the agency by anti-abortion groups including the Alliance for Hippocratic Medicine plays out.
The groups sued the FDA in November 2022, just months after the U.S. Supreme Court overruled Roe v. Wade, seeking to undo the agency's approvals of the brand-name drug Mifeprex and the generic version of the drug, mifepristone.
The anti-abortion groups, along with a handful of individual physicians, claim that medication abortions are dangerous, that the FDA should not have approved mifepristone and that the agency has removed safeguards once in place to protect women and girls.
The group not only sought to block an FDA January 2023 rule change that permanently lifted a restriction requiring in-person dispensing of the abortion pill and permitted pharmacies to fill mifepristone prescriptions for customers directly, it also sought to overturn all FDA approvals of mifepristone dating back to the agency's initial decision to greenlight the drug back in 2000.
The FDA, for its part, has repeatedly said mifepristone is safe and effective.
The agency has argued that serious adverse events associated with the drug are a "rarity" and that plaintiffs have provided no evidence that, in the absence of a preliminary injunction, mifepristone's continued availability on the market would cause them any harm.
In its briefs, the FDA further argued that a preliminary injunction threatens to cause significant harm to patients and would upend the status quo relied on by businesses and workers involved in mifepristone's manufacturing and distribution.
In a hearing on the motion for a preliminary injunction, held on March 15 in Amarillo, Texas, counsel for the government told Judge Kacsmaryk that a preliminary injunction could have a broader impact on the U.S. pharmaceutical industry.
Julie Straus Harris, counsel for the FDA, told the judge a preliminary injunction in the case "would leave pharmaceutical companies unable to confidently rely on FDA approval decisions to develop the pharmaceutical drug infrastructure that Americans depend on to treat a variety of health conditions."
The anti-abortion groups are represented by Erik C. Baptist, Erin Morrow Hawley, Matthew S. Bowman, Erica Steinmiller-Perdomo, Julie Marie Blake and Denise M. Harle of the Alliance Defending Freedom and Christian D. Stewart of Morgan Williamson LLP.
The government is represented by Noah T. Katzen of the U.S. Department of Justice's Civil Division's Consumer Protection Branch.
The case is Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al., case number 2:22-cv-00223, in the U.S. District Court for Northern District of Texas.