Generic Abortion Pill Manufacturer Sues FDA As Mifepristone Faces Supreme Court Battle

Topline

The manufacturer of a generic version of the abortion drug mifepristone sued the Food and Drug Administration on Wednesday to prevent any new restrictions on the pill, ahead of a Supreme Court decision that could decide whether the drug’s FDA approval remains in place.

Generic mifepristone manufacturer GenBioPro has sued the FDA amid a series of legal conflicts … [+] concerning the abortion pill.

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Key Facts

Las Vegas-based pharmaceutical company GenBioPro, which says it supplies roughly two-thirds of the pills used for medication abortions in the U.S., filed the lawsuit less than two hours before the Supreme Court extended a temporary ruling to leave federal approvals for mifepristone in place.

The Supreme Court was expected to rule by midnight on whether to greenlight a lower court order imposing certain restrictions on mifepristone, including the FDA’s 2019 approval of the generic brand of the drug—but SCOTUS extended its deadline until midnight on Friday.

The suit asks a federal court in Maryland to prevent the FDA from ”depriving GenBioPro of its constitutional and statutory right to market mifepristone” by revoking approval of the drug without a more in-depth process.

GenBioPro is seeking court orders that would require the FDA to go through certain steps before declaring mifepristone unapproved, and is also asking the court to bar the federal government from taking enforcement actions against the company before the FDA has gone through a statutory process of withdrawing or suspending the pill.

The company alleges it has made multiple attempts to get assurance from the FDA that it would go through the multistep withdrawal process mandated by Congress before revoking approval, but the agency did not offer those assurances, GenBioPro claims.

Key Background

On April 7, Texas federal district judge Matthew Kacsmaryk issued a preliminary ruling suspending mifepristone’s FDA approval, following a lawsuit from anti-abortion groups arguing the FDA did not follow proper approval procedures. The unprecedented ruling would have sharply curtained access to abortion nationwide—including in states where the procedure remains legal—almost a year after the Supreme Court overturned Roe v. Wade and gave states the power to ban abortion for the first time in a half-century. The U.S. 5th Circuit Court of Appeals ruled last week the FDA’s approval of brand-name mifepristone in 2000 could remain in place, but it reimposed certain limitations on the drug, including suspending approval of the generic brand of mifepristone. The Supreme Court temporarily blocked that ruling, but the stay is now set to expire on Friday at 11:59 p.m. If the Supreme Court does not act before then, the restrictions would take effect and GenBioPro’s FDA approval would be revoked.

What We Don’t Know

It remains unclear how the new lawsuit will impact the existing legal conflicts over mifepristone. Kacsmaryk’s ruling was part of a lawsuit against the FDA from the Alliance for Hippocratic Medicine, which alleged the FDA did not properly approve mifepristone for terminating pregnancies. Meanwhile, 17 states and Washington, D.C., filed a separate lawsuit earlier this year asking a court to prohibit the FDA from rolling back access to the abortion pill, and the same night as Kacsmaryk’s ruling, a federal judge in Washington state blocked the FDA from curtailing mifepristone access in the states that brought the suit. The conflicting rulings have brought the case to the Supreme Court, but GenBioPro’s suit is not a party in the Supreme Court case.

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