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A federal judge in Texas has suspended US approval of the abortion medication mifepristone, one of the two drugs commonly used for medication abortions, in a closely watched case brought by anti-abortion activists.
On Friday, the US district judge Matthew J Kacsmaryk, a Trump administration appointee in Amarillo, Texas signed an injunction directing the Federal Drug Administration (FDA) to pause mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues.
The ruling throws into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval. It was not immediately clear how the ruling would be implemented, or how quickly access to the abortion pill might be curtailed.
The case against the FDA was brought by Alliance Defending Freedom (ADF), a Christian conservative legal advocacy group, arguing that the FDA exceeded its regulatory authority when it approved mifepristone more than two decades ago, in 2000.
The judge didn’t go as far as the plaintiffs wanted by withdrawing or suspending the approvals of chemical abortion drugs and removing them from the list of approved drugs. But he put a “stay” or hold on approval of the drug. His ruling, however, doesn’t immediately go into effect, as he gives the federal government seven days to appeal, which federal lawyers representing the FDA are expected to do so swiftly.
The complainants also included other widely disputed claims in their case, arguing the FDA’s decision to extend the gestational age up to which mifepristone could be prescribed put pregnant women and girls at risk; and that the FDA’s 2021 decision to remove the in-person dispensing requirement over mifepristone during the pandemic put pregnant people at risk. They also claimed the FDA “failed to acknowledge and address the federal laws that prohibit the distribution of chemical abortion drugs by postal mail”, invoking a 19th-century law which made it illegal to send “obscene, lewd or lascivicious” items through the mail, including pornography and abortifacients.
“Simply put, FDA stonewalled judicial review – until now,” Kacsmaryk wrote in his 67-page ruling.
Mifepristone has been repeatedly found to be safe and effective and is used across the world. Joe Biden’s administration, responding to the lawsuit, has said the drug’s approval was well supported by science and that the challenge to the FDA comes much too late.
The US justice department has also argued that a ruling in favor of the plaintiffs would undercut trust in the FDA, the agency that signs off on the safety of food products and drugs in the US and would increase the burden on surgical abortion clinics already overcrowded with women coming from states that now ban abortion.
The FDA warned in legal arguments in January that a decision in favor of the ADF would do “longstanding scientific determination based on speculative allegations of harm”, and would “upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution”.
Jenny Ma, senior counsel to the Center for Reproductive Rights, warned that “if plaintiffs can just bring lawsuits like this, based on junk science, the impact goes far beyond medication abortion. It really seeks to undermine the entirety of FDA authority over drug approval.”
Kacsmaryk, a Trump-appointed judge, is thought to have been targeted by the ADF in a process known as “judge shopping” because of his work with far-right organizations. He previously worked for the First Liberty Institute, a conservative Christian organization that focuses on litigation against LGBTQ+ and abortion rights.
Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.
The decision represents major victory for the anti-abortion movement less than a year after the supreme court overturned Roe v Wade, which guaranteed a constitutional right to abortion and led to full abortion bans in 13 states, while 16 states have laws specifically targeting abortion medications.
Advocates and progressive states have been bracing for the national reverberations of Kacsmaryk’s decision. This week the governor of Washington state said it had purchased a three-year supply of the leading abortion medication in anticipation.
Jay Inslee, a Democratic lawmaker, said he ordered the department of corrections, which has a pharmacy license, to buy 30,000 doses of the generic version of mifepristone at a cost of about $1.28m, or $42.50 each pill. The shipment arrived in late March.
“This Texas lawsuit is a clear and present danger to patients and providers all across the country,” Inslee said in a statement. “Washington will not sit by idly and risk the devastating consequences of inaction.”
Mifepristone is also the subject of lawsuits in West Virginia and North Carolina seeking to expand access to the drug by arguing that state restrictions conflict with federal law, and a lawsuit by Democratic state attorneys general seeking to remove federal restrictions on how it can be distributed.
The Associated Press and Reuters contributed reporting.
English (US)