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A judge blocked federal approvals for the abortion pill mifepristone Friday while litigation plays out, largely siding with anti-abortion rights advocates and throwing millions of Americans’ access to medication abortion into doubt in the wake of the Supreme Court overturning Roe v. Wade—but another judge issued a conflicting ruling minutes later.
Texas-based U.S. District Judge Matthew Kacsmaryk put his ruling against mifepristone on hold for a week so the federal government can file an appeal, after which the Food and Drug Administration’s approval of the drug—which dates back to 2000—will be halted.
In a separate case the same evening, federal Judge Thomas Rice in Washington state barred the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone,” setting up a possible conflict between two courts—though Rice’s ruling only applies to 17 states plus Washington, D.C., that brought the case.
Anti-abortion rights advocates sued the Food and Drug Administration in the Texas case in November, seeking to revoke the FDA’s approval of abortion drug mifepristone because they argued the drug shouldn’t have been approved in the first place.
Kacsmaryk, a Trump appointee, issued a preliminary injunction that will effectively stay the drug’s approval, instead of ordering the FDA to fully withdraw it as the plaintiffs proposed.
The Texas judge wrote in a 67-page ruling he “does not second-guess FDA’s decision-making lightly” but the FDA “acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
Many states have already banned abortion entirely or enacted restrictions on abortion pills, but Kacsmaryk’s order means even states where prescription of the pills has gone largely unrestricted could be affected.
The FDA has not yet responded to a request for comment.
53%. That’s the percentage of all abortions in the U.S. that were medication abortions in 2020, the most recent year for which data is available, according to the pro-abortion rights Guttmacher Institute.
What To Watch For
If it goes into effect, Kacsmaryk’s ruling could cut off an additional 40 million American women’s access to abortion, according to a study by pro-abortion rights group NARAL Pro-Choice America released in February. The case is still playing out in court, suggesting Kacsmaryk or another judge could restart access to abortion pills, and this order is likely to be swiftly appealed. The case will likely next go to the Fifth Circuit Court of Appeals, which is also known for being one of the most conservative courts in the country.
Medication abortion has been repeatedly shown in studies to be safe and effective. The process consists of two abortion drugs: mifepristone, which terminates a pregnancy, and misoprostol, which helps expel the tissue. Abortion pills have become a greater debate in the wake of the Supreme Court overturning Roe v. Wade in June, which led to state-level abortion bans across the country and dozens of clinics stopping abortion procedures. The bans have made pills more prominent as an abortion method, as they’re easier for people in states where abortion is banned to obtain and travel to other states to receive. Services like mail orders of abortion pills—which can raise legal concerns—and mobile clinics dispensing abortion pills on state borders have sprung up in response, with VICE News reporting at least 20,000 packets of pills have been covertly shipped in the U.S. in the six months since the Supreme Court’s ruling. The Biden Administration has also sought to expand access to abortion pills, making abortion pills available at retail pharmacies and issuing guidance clarifying the pills can be legally mailed to states where abortion is banned under federal law. The growing importance of medication abortion to abortion access has made anti-abortion rights advocates step up their opposition to the pills in response, with multiple bills now pending in state legislatures that would enact further restrictions on them in addition to the lawsuit challenging their approval.
Legal experts have suggested Kacsmaryk’s ruling may not be as impactful as feared, given the constraints on the judiciary’s power over the FDA. The FDA has a legal process to revoke a drug’s approval that could take months or years to play out, experts wrote in Slate, and federal courts cannot legally force the agency to adopt a different process. Courts also cannot force the FDA to take enforcement action against drugs that are being sold without formal FDA approval, meaning the agency could decide to simply allow mifepristone to continue to be sold even without formal approval without pharmaceutical companies or customers facing any consequences. Since only one manufacturer of mifepristone, Danco, is involved with the lawsuit, the experts also argue Kacsmaryk’s ruling cannot block GenBioPro, the other company manufacturing the drug, from continuing to produce it.
Abortion providers said ahead of Kacsymarky’s ruling that if mifepristone is blocked they will also continue to provide medication abortions using only misoprostol, which is commonly used in combination with mifepristone for medical abortions. The misoprostol-only method has been found to be between 80 to 100% effective in terminating a pregnancy, versus a 99.6% effective rate with mifepristone, and has been recommended by the World Health Organization as a safe alternative to using mifepristone and misoprostol together. Misoprostol has not been subject to the same legal scrutiny as mifepristone has and is more readily available, as it’s also used to treat other conditions.
Vice President Kamala Harris spoke out against the lawsuit and expected ruling against abortion pills during a White House meeting on reproductive healthcare on February 24—the first day that Kacsmaryk’s ruling could have been issued—describing the attempt to revoke FDA approval for the drug as “an attack on the very foundation of our public health system.” “Those who would attack this process and the ability of the FDA to make these decisions ought to look in their own medicine cabinets to figure out where they’re prepared to say that those medications that they need … should no longer be available to them,” Harris said. “Because that is what we are talking about.”
What We Don’t Know
What other medications could now be at risk if courts are willing to strike down drugs’ FDA approval. Anti-abortion rights advocates have already taken aim at other controversial drugs like those used to prevent HIV or vaccines, and those attacks could now ramp up with Kacsmaryk’s ruling bolstering their efforts. Pharmaceutical industry officials cited by STAT suggested a ruling could also hinder research efforts to develop future medications that could be considered more politically divisive or induce miscarriages, even if their main purpose isn’t for abortion.
New Lawsuit Aims To Revoke FDA Approval Of Abortion Drug (Forbes)
Ruling Could Cut Off 40 Million Women’s Abortion Access, NARAL Study Says (Forbes)
Abortion Pills: What To Know About Mifepristone As Biden Administration Defends It From Legal Attack (Forbes)