A federal judge in Texas issued a preliminary ruling that invalidated the 23-year-old Food and Drug Administration approval of the abortion pill mifepristone, an unprecedented injunction that — if upheld through court action — could make it more difficult for patients to have an abortion in states where abortion is legal, not just states that try to restrict it.
The drug will remain available at least for the foreseeable future, as the Texas judge suspended its own order for seven days to give the FDA time to ask an appeals court to intervene.
Less than an hour after Judge Kacsmaryk’s ruling, a Washington state judge issued a ruling directly contradicting Texas’ decision, ordering the FDA not to make any changes to the availability of mifepristone.
The conflicting orders from two federal judges appear to be creating a legal stalemate that is likely to escalate to the Supreme Court.
The The order from Judge Kacsmaryk, a Trump appointee who has written critically of Roe v. Wade, is the first ruling in a case that could lead to the most sweeping abortion decision since the Supreme Court overturned Roe v. Wade last June.
The lawsuit, brought by a coalition of anti-abortion groups and doctors, seeks to end more than 20 years of legal use of mifepristone, the first pill in the dual-drug abortion regimen.
The lawsuit in Washington state was brought against the FDA by more than a dozen Democratic attorneys general. In a preliminary injunction in that case, Judge Thomas O. Rice blocked the agency from “taking any action to remove mifepristone from the market or otherwise cause the drug to become less available.”
Medical abortion is the method used in more than half of abortions in the United States. The lawsuit alleges that the FDA did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and has since ignored the medication’s safety risks.
Abortion rights advocates reacted angrily to the decision in Texas.
“This lawsuit was drafted as part of an orchestrated campaign to deny all women in the U.S. access to abortion, even those who live in states with strong abortion rights protections,” said Nancy Northup, president and chief executive of the Center for Reproductive Health. Rights. “While the decision is ill-founded, the impact is devastating and threatens access to a safe and effective drug that has been used by more than five million patients over the past two decades.”
Erik Baptist, an attorney for the anti-abortion groups that brought the Texas case, called the decision “an important victory for the physicians and medical associations we represent, and more importantly, the health and safety of women and girls. ” Mr Baptist, who is senior counsel for the Alliance Defending Freedom, a conservative Christian legal organization, said: “By illegally approving dangerous chemical abortion drugs, the FDA has put women and girls at risk, and it is high time the agency being held accountable. for his reckless actions.”
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Legal experts said that even if the Texas ruling is eventually upheld, there would be several legal options that would allow mifepristone manufacturers to continue to supply the drug and suppliers to continue to prescribe it to patients.
Shortly after Friday night’s rulings, the CEO of GenBioPro, one of two manufacturers of mifepristone in the United States, issued a statement saying the company was reviewing both judges’ decisions.
“We will take all necessary steps to make mifepristone legally available and accessible to as many people as possible in the country,” said the CEO, Evan Masingill.
And if legal access to mifepristone is blocked, some abortion providers plan to provide only the second abortion medication, misoprostol, which is safe to use on its own in many countries where mifepristone is less available. Misoprostol, a drug approved for other medical uses, causes contractions similar to miscarriage and is considered slightly less effective on its own than when combined with mifepristone and more prone to side effects such as nausea.
In the Texas lawsuit, the plaintiffs are also seeking to ban the use of misoprostol for abortion, but their request for a preliminary injunction focused on mifepristone.
Since last year’s Supreme Court ruling overturning national abortion rights, the pills used in drug-induced abortions have increasingly become the focus of political and legal battles. Some conservative states, in addition to banning or restricting abortion in general, have begun considering legislation specifically targeting abortion pills. And several recent lawsuits have been filed to preserve or expand access to medication abortion.
The FDA and the Justice Department strongly disputed the claims in the lawsuit, saying the federal agency’s rigorous reviews of mifepristone over the years had repeatedly confirmed its decision to approve mifepristone, which blocks a hormone that may make pregnancy possible. makes. In a lawsuit filing the case, the FDA said reversing mifepristone’s approval would cause “significant harm, denying patients a safe and effective drug that has been on the market for more than two decades.”
The lawsuit filed in Washington state was intended as a direct challenge to the Texas case. Democratic attorneys general filed the case in late February, on the first day that Judge Kacsmaryk could have issued a ruling. While the main claims were aimed at eliminating a framework of additional restrictions that the FDA has long placed on mifepristone, the judge in the lawsuit was also asked to declare that the FDA’s “approval of mifepristone is lawful and valid” and the FDA prohibit “any action to remove mifepristone from the market or reduce its availability.”
At a news conference earlier this week, Washington Attorney General Bob Ferguson said that 17 states had joined the lawsuit as plaintiffs.
“Two different federal lawsuits in two different jurisdictions,” said Mr. Ferguson. “And so there is the possibility for two decisions or judges that are effectively opposite to each other. In other words, a Texas judge could potentially say, “Hey, I’m issuing a cross-country ban on mifepristone,” and a Washington state judge in the case involving 17 other states could say, “no, no.” , it’s not just available, you need to expand access to it.’”
The case has sparked great concern in the reproductive health community. It was filed by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as members and was founded in August in Amarillo, Texas, where the case was filed. Judge Kacsmaryk is the sole federal judge for the Amarillo Division in the Federal District Court for the Northern District of Texas.
The FDA has regulated mifepristone more strictly than many other drugs and has regularly reviewed evidence for its safety and effectiveness.
For a decade or so, the agency has imposed an additional framework of restrictions and monitoring for the drug. This framework, called a Risk Evaluation and Mitigation Strategy or REMS, has been used for only about 300 other drugs, of which only 60 are currently covered.
In recent years, the FDA has extensively reviewed new data on mifepristone and lifted several restrictions, including requiring patients to get the drug in person from a provider.
Some of the same anti-abortion organizations that filed the lawsuit in Texas had previously filed citizen petitions in 2002 and 2019 opposing the FDA’s actions against mifepristone. Both were rejected by the agency as unfounded. And a 2008 review by the Government Accountability Office found no irregularities in the FDA’s approval of mifepristone.
Legal experts said the ruling appeared to be the first time a court had acted to order that a drug be withdrawn from the market over FDA objections and that if the ruling stood, it could have implications for the federal authority to regulate other drugs. types of medicines.
Adam Liptak reporting contributed.
