The Texas ruling against the Food and Drug Administration’s (FDA) approval of mifepristone, a pill that can be used for an abortion up to 10 weeks of pregnancy, could have major implications for abortion access throughout the country.
U.S. District Judge Matthew Kacsmaryk issued his ruling, which could stop the prescribing and distribution of mifepristone, after deciding that the FDA improperly rushed the approval process for the drug and allowed a dangerous drug regimen to make it to market.
The Biden administration plans to challenge the ruling, and higher courts will likely step in to settle the case after a separate ruling from another case upheld access to the pill in certain states.
Here’s four things to know about the Texas abortion pill ruling:
Invalidates the FDA’s 23-year-old approval of the drug
The FDA originally approved mifepristone, one of two pills approved for abortions, in 2000 after a four-year approval process.
The agency said in a statement that it approved the pill following a “comprehensive review” of the available scientific evidence and determined that it was safe and effective. It said it is standing by its approval of the drug.
“FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses,” the agency said.
But Kacsmaryk sided with an antiabortion group in the case, finding that the agency rushed the process and violated federal standards.
“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,” his ruling states.
Kacsmaryk also hinted that the agency might have given in to political pressure to approve the drug and alleged that it “stonewalled” any potential challenges to its approval.
Could have a far-reaching impact on abortion nationwide
The case only directly concerned the Northern District of Texas, a relatively small geographic area compared to the entire country, but its impact could affect abortion access in the entire country if the ruling stands.
Kacsmaryk’s ruling found that the approval process for mifepristone was flawed, which would revoke access not just in the district where the case happened but the entire country.
Democrats who have criticized the ruling have specifically noted that just one judge issued the ruling that potentially has nationwide implications for abortion rights.
“Today a single federal district judge in Texas ruled that a prescription medication that has been available for more than 22 years, approved by the FDA and used safely and effectively by millions of women here and around the world, should no longer be approved in the United States,” President Biden said. “The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs.”
Nothing changes immediately as government and manufacturer appeal
Although Kacsmaryk’s ruling could have significant lasting effects, it did not go into effect immediately. He gave the government one week to file an appeal and request emergency relief before the ruling goes into effect.
Multiple parts of the Biden administration quickly responded by filing their appeals to the Fifth Circuit Court of Appeals within hours of the ruling. The FDA filed its appeal on Friday, and Attorney General Merrick Garland said the Justice Department would also appeal the ruling.
Danco Laboratories, the manufacturer of the pill, also appealed the ruling.
“This is a dark day for public health, especially for reproductive rights and the reliance on science and medical expertise to guide decisions about what drugs are safe and effective and should be available to patients,” said Abby Long, Danco’s director of public affairs.
With the appeals filed, the Fifth Circuit needs to grant at least one of them emergency relief to prevent Kacsmaryk’s ruling from going into effect at the end of next week. Without the emergency relief, access to the pill could be cut off.
Will likely go to the Supreme Court
Aside from the appeals, a higher court will likely need to step in because at almost the same time on Friday as Kacsmaryk’s ruling, U.S. District Judge Thomas Rice, in the Eastern District of Washington, issued an injunction that could protect access to mifepristone.
Rice’s ruling stops the FDA from “any action to remove mifepristone from the market or otherwise cause the drug to become less available.” He ruled that the FDA cannot alter “the status quo and rights as it relates to the availability of Mifepristone” in the 17 states and Washington, D.C. that brought a lawsuit arguing that too many regulations exist on the drug.
The rulings from Kacsmaryk and Rice conflict with each other and would likely require higher courts to settle the dispute. A higher court ruling could also concern the broader authority of the FDA.
“Based on the public health and administrative considerations at issue in this case, Plaintiffs have shown the balance of the equities sharply tip in their favor and the public interest favors a preliminary injunction,” Rice’s ruling states.
Opposing sides of the case can also appeal beyond the Fifth Circuit, likely granting the Supreme Court at least the opportunity to weigh in, which it might be likely to do for a case with such major implications for abortion rights after Roe was overturned.