In an unprecedented decision, a federal judge in Texas has issued a stay that will shut down the prescribing and distribution of mifepristone in seven days, one of two drugs used for medication abortions that has been on the market in the U.S. for more than two decades.
District Court Judge Matthew Kacsmaryk, an appointee of former President Trump, gave the government a weeklong window to appeal and seek emergency relief before his ruling goes into effect.
The FDA can appeal the decision to the conservative 5th Circuit Court of Appeals, and the judge has given the federal government seven days to seek relief. The case could eventually reach the Supreme Court.
The ruling could have far-reaching implications for access to abortion nationwide, as well as the authority of the entire Food and Drug Administration.
Kacsmaryk sided with the antiabortion group that brought the lawsuit and said the agency’s approval process was improperly rushed, and resulted in an unsafe drug regimen getting on the market.
Kacsmaryk said that FDA violated federal standards when it first approved mifepristone 23 years ago.
“The Court does not second-guess FDA’s decision-making lightly. But here, 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.”
He also hinted the agency bowed to political pressure, and deliberately “stonewalled” any challenges to the drug’s approval.
“Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review — until now,” he wrote.
The drug was first approved in 2000, a process that took more than four years. It is indicated for use in abortions up to 10 weeks into a pregnancy. Mifepristone is also used by OB-GYNs to manage early miscarriages.
But the stay means FDA’s longstanding approval has been blocked, a move that the Justice Department argued was “extraordinary and unprecedented.” In court filings ahead of the March 15 hearing, the government said the lawsuit was based on false claims of severe complications from the drug.
The lawsuit was initially filed in November by the Alliance Defending Freedom (ADF), a powerhouse conservative legal group that has helped author states’ anti-abortion laws and defended Mississippi in the case that led the Supreme Court to overturn the abortion protections granted in Roe v. Wade.
The lawsuit claims the drug is unsafe and alleges that the FDA failed to study it carefully enough. Legal experts said the argument was purely political and had no merit, but the lawsuit was strategically filed in the Northern District of Texas so that Kacsmaryk was guaranteed to hear it.
Medication abortion is the most common method for terminating a pregnancy, and ever since the Supreme Court’s decision overturning Roe v. Wade in June, pregnant Americans have increasingly turned to abortion pills.
This story was updated at 7:05 p.m.
Many of the country’s leading medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, said medication abortion is safe and effective.
Despite arguments from anti-abortion advocates, the medical groups said years of clinical evidence has shown there is a greater risk of complications or mortality for procedures like wisdom tooth removal, cancer-screening, colonoscopy, or the use of Viagra.
Medication abortion in the U.S. is a two-step process. The first step involves taking mifepristone, which is followed up 24 hours later by a dose of misoprostol, a drug first approved in the 1970s for stomach ulcers. In the absence of mifepristone, medical providers have said they would offer misoprostol only, though studies have shown it to be less effective
