A federal judge in Texas has issued a preliminary ruling nullifying the Food and Drug Administration’s 23-year-old approval of the abortion drug mifepristone, an unprecedented order – if it passes challenges Court rules – can make it harder for patients to get an abortion in states where abortion is legal, not just in places that try to restrict it.
The drug will continue to be available at least for the short term because Judge Matthew J. Kacsmaryk upheld his own order for seven days to give the FDA time to ask the appeals court to intervene.
Less than an hour after Judge Kacsmaryk’s ruling, a judge in Washington state issued a ruling in another lawsuit, contradicting Texas’ decision, asking the FDA not to change mifepristone’s availability. in 18 states filed that lawsuit.
The conflicting orders of two federal judges, both preliminary orders issued before the full cases are heard, appear to create a legal deadlock that is likely to escalate to the Court Supreme Court.
President Biden said his administration would fight the Texas ruling. “This doesn’t just affect women in Texas,” he said in a statement. “If it stands, it will prevent women in every state from accessing the drug, regardless of whether abortion is legal in that state.”
Order of Judge Kacsmaryk, a Trump appointee who wrote a review of Roe sues Wadeis the initial ruling in a case that could lead to the most serious abortion decision since the Supreme Court overturned Roe v. Wade last June.
On Friday night, the Justice Department filed a notice that it was appealing the Texas ruling.
“Today’s decision reverses the FDA’s expert judgment, made more than two decades ago, that mifepristone is safe and effective.” Attorney General Merrick B. Garland said in a statement, adding that the Justice Department will ask to uphold the decision while the appeal is pending. He said the department is reviewing the ruling in Washington’s case.
The lawsuit, filed by a coalition of anti-abortion groups and doctors, aims to end more than 20 years of legal use of mifepristone, the first pill in a two-drug abortion regimen.
The Washington State lawsuit was filed against the FDA by 18 Democratic attorneys general, who are challenging the agency’s restrictions on the prescribing and dispensing of mifepristone. In a preliminary order in that case he filed with the states that sued, Judge Thomas O. Rice prevented the agency from taking “any action to remove mifepristone from the market or say the other way is to make this drug less available.”
Medical abortion is the method used in more than half of all abortions in the United States. The lawsuit claims that the FDA failed to adequately consider the scientific evidence or follow proper procedures when approving mifepristone in 2000, and has since ignored the drug’s safety risks.
The FDA and the Department of Justice have strongly denied the claims in the lawsuit, saying that rigorous federal agency reviews of mifepristone over the years have repeatedly reaffirmed the decision to approve mifepristone, the drug that blocks mifepristone. a hormone that allows pregnancy to develop. In a statement Friday night, the agency said: “The FDA supports its determination that mifepristone is safe and effective under the approved conditions of use for early pregnancy termination and believes that the disease Individuals should have access to FDA-approved drugs that FDA has determined to be safe and effective for their intended use.”
In Texas’ 67-page ruling, Judge Kacsmaryk appeared to agree with virtually all statements made by anti-abortion groups and repeatedly used the language of abortion opponents, calling abortion pills is a “chemical abortion” and refers to the fetus as an “unborn person” or “unborn child”.
“The court did not take the FDA’s decision lightly,” the judge wrote. “But here, the FDA agreed to its legitimate safety concerns — in violation of its statutory obligation — on the grounds that it was clearly unfounded and the studies did not support the conclusion. their. There is also evidence that the FDA faces significant political pressure to waive proposed safety precautions in order to better promote political aims to increase ‘access’ to chemical abortion.”
An attorney for Danco Laboratories, which makes the branded version of mifepristone, called Mifeprex, and which joined the lawsuit on the FDA’s side, strongly disagreed with the judge’s characteristics.
“The court ruling rewrites the facts and the law to tell its preferred story – it is a story that contradicts established legal principles and with a well-established safety record. of Mifeprex,” attorney Jessica Ellsworth, said in a statement. Danco has filed a notice that it is appealing the ruling.
Erik Baptist, an attorney for anti-abortion groups that filed the lawsuit in Texas, called the decision “an important victory for the doctors and medical associations we represent, and more importantly, for the health of the community.” health and safety of women and girls.” “By illegally approving dangerous chemical abortion drugs, the FDA has placed a dependency on abortion,” said Baptist, senior counsel with Alliance Defending Freedom, a conservative Christian legal organization. Women and girls are in peril, and it is time for this agency to be held accountable for its reckless actions.”
Legal experts say that even if the Texas ruling is ultimately upheld, there will be a number of legal options that could allow mifepristone manufacturers to continue to supply the drug and suppliers to continue. prescribing to patients.
Shortly after Friday night’s ruling, the chief executive officer of GenBioPro, one of the two manufacturers of mifepristone in the United States, released a statement saying the company is reviewing both judges’ decisions.
“We will take whatever steps are necessary to make mifepristone legally available and accessible to as many people as possible in the country,” said a statement from Chief Executive Officer, Evan Masingill.
And if legal access to mifepristone is blocked, some abortion providers plan to offer only a second type of abortion pill, misoprostol, which is safely used alone in many countries. where mifepristone is less available. Misoprostol, a medication approved for other medical uses, causes contractions similar to a miscarriage and is considered slightly less effective than when combined with mifepristone and is more likely to cause miscarriage. side effects such as nausea.
In the Texas case, the plaintiffs also sought to ban the use of misoprostol for abortion, but their request for a preliminary injunction focused on mifepristone.
Since a Supreme Court ruling last year overturned national abortion rights, the pills used in medical abortions have increasingly become the focus of political and legal battles. Some conservative countries, in addition to banning or restricting abortion in general, have begun to consider legislation that specifically targets the abortion pill. And some recent lawsuit was filed in an attempt to maintain or expand access to medical abortion.
The lawsuit filed in Washington state aims to be a direct challenge to the Texas case. The Democratic attorney general filed the case in late February on the first day that Judge Kacsmaryk could issue a ruling. While its key statements seek to remove a framework of additional restrictions that the FDA has long imposed on mifepristone, the lawsuit also asks the judge to declare that “FDA approval of mifepristone is legal and valid” and asks the FDA “not to take any action to remove mifepristone from the market or reduce its availability.”
During a press conference earlier this week, Washington’s attorney general, Bob Ferguson, described the lawsuit he and other attorneys general filed as “the opposite of what is happening in Texas.” He added, “So there are likely to be two decisions or judges that are, in fact, contradictory. In other words, a judge in Texas might say ‘Hey, I’m issuing a nationwide ban on mifepristone’ and a judge in Washington State in a case against 17 other states might say ‘no, no, no only available, you have to extend access to it.’”
The incident caused a stir in the reproductive health community. It was filed by the Hippocratic Medical Union, a organization lists five anti-abortion groups that are members of it and are was founded in August in Amarillo, Texas, where the case was filed. Judge Kacsmaryk is the sole federal judge in charge of the court’s Northern District Amarillo division.
The FDA has regulated mifepristone more strictly than many other drugs and regularly reviews the evidence for its safety and effectiveness.
For decades, the agency has imposed a limited framework and additional oversight on the drug. Called Strategies for assessing and mitigating risksor REMS, that framework was used for there are only about 300 other drugsonly 60 of which it currently covers.
In recent years, the FDA has extensively reviewed new data on mifepristone and has lifted some restrictions, including requiring patients to receive the drug directly from a provider.
In 2002 and 2019, several anti-abortion organizations filed lawsuits in Texas that had previously filed citizen petitions opposing FDA actions against mifepristone. Both were denied by the agency as unfounded. And a 2008 review by the Government Accountability Office found no anomalies in the FDA’s approval of mifepristone.
Legal experts say the ruling appears to be the first time a court has ordered a drug removed from the market in the face of objections from the FDA, and that if the ruling goes into effect, it could have consequences. to the federal agency in regulating other drugs. drugs.
In his statement, Mr. Biden said, “If this ruling were to go into effect, there would be virtually no prescription, FDA-approved, that would be safe from these kinds of political, ideological attacks.” .”
Adam Liptak contribution report.
