In an unprecedented move, U.S. District Judge Matthew Kacsmaryk on Friday suspended the Food and Drug Administration's longtime approval of key abortion pill mifepristone, though he gave the government a week to appeal his decision. If the ruling does eventually go into effect, it would curtail access to the standard regimen for medication abortion nationwide.
The FDA approved mifepristone more than 20 years ago to be used in combination with a second drug, misoprostol, to terminate pregnancies at up to 10 weeks. Over half of U.S. abortions are done by medication abortion, according to the Guttmacher Institute, a research group that supports abortion rights.
The pills have become increasingly significant in the fight over abortion access since Roe v. Wade was overturned last June.
President Joe Biden on Friday said his administration would fight the ruling, and the Justice Department signaled it would appeal.
A coalition of anti-abortion groups, collectively called the Alliance for Hippocratic Medicine, sued in November challenging the process through which the FDA evaluated and approved mifepristone. They argue that the government did not adequately assess the drug’s safety and should not have made it accessible via telehealth during the pandemic.
The plaintiffs sought an injunction — which the judge granted, in part — to halt the use of mifepristone nationwide while the case plays out.
"The Court does not second-guess FDA’s decision-making lightly," Kacsmaryk wrote. "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."
If the stay on the FDA's mifepristone approval goes into effect, the drug would no longer be available anywhere in the U.S. That would leave a surgical procedure or off-label use of misoprostol on its own as the only options in states where abortion is legal.
Misoprostol, which is not affected by the injunction, is not FDA-approved to terminate pregnancies on its own — doctors would have to prescribe it off-label for that purpose. Some abortion providers said they intend to do that if access to mifepristone is cut off, even though the one-drug approach has been shown in clinical trials to be somewhat less effective than the two-pill regimen.
Biden said the Texas ruling poses a risk to abortion rights everywhere in the nation.
“This does not just affect women in Texas — if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state,” Biden said in a statement. “It is the next big step toward the national ban on abortion that Republican elected officials have vowed to make law in America.”
On Friday night, the Department of Justice filed a notice of appeal to the 5th Circuit Court of Appeals, indicating that the government plans to appeal. Attorney General Merrick Garland also said in a statement that the DOJ plans to appeal Kacsmaryk’s decision.
“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision,” Garland said.
Defendant Danco Laboratories, which manufactures mifepristone, also filed a notice of appeal to the 5th Circuit on Friday.
The case could be a new test for the Supreme Court
The Supreme Court is likely to have the final word on whether the Texas ruling goes into effect.
Even if the 5th Circuit Court in New Orleans does block Kacsmaryk’s ruling, the challengers could ask the Supreme Court to overturn that decision.
So either way, the case is likely to test the Supreme Court’s pronouncement last summer when it overturned Roe v. Wade that it was leaving the issue of abortion to the states and other branches of government to decide as a policy question.
In his concurring opinion, Justice Brett Kavanaugh stressed that the ruling “does not prevent the numerous states that readily allow abortion from continuing to allow abortion.”
The votes of Kavanaugh and Chief Justice John Roberts, who voted against overturning Roe, could be pivotal.
Reactions to Kacsmaryk’s decision
Vice President Kamala Harris said on Friday that the Biden administration “will stand with the women of America."
"Today’s unprecedented decision threatens the rights of women nationwide to make decisions about their health care and the ability to access medication prescribed to them by their doctors," she said in a statement. "Simply put: this decision undermines the FDA’s ability to approve safe and effective medications — from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin — based on science, not politics. This decision threatens the rights of Americans across the country, who can look in their medicine cabinets and find medication prescribed by a doctor because the FDA engaged in a process to determine the efficacy and safety of that medication."
Erik Baptist, senior counsel for the Alliance Defending Freedom, which represents the plaintiffs in the Texas case, said the FDA never had the authority to approve abortion pills.
“This is a significant victory for the doctors and medical associations we represent, and more importantly the health and safety of women and girls,” he said.
However, Nancy Northup, president and CEO at the Center for Reproductive Rights, said in a statement that the decision "has no basis in law or fact."
"This lawsuit was manufactured as part of an orchestrated campaign to deny all women in the U.S. access to abortion, even those living in states with strong abortion rights protections," she said.
An unprecedented legal challenge to the FDA's approval process
In the lawsuit, the Alliance for Hippocratic Medicine alleges that medication abortion has “potentially serious and life-threatening effects.” However, studies suggest that when mifepristone and misoprostol are used together in consultation with doctors, the regimen successfully terminates pregnancies up to 99.6% of the time and has a 0.4% risk of major complications.
In court filings, the FDA said that it “extensively reviewed the scientific evidence and determined that the benefits of mifepristone outweigh any risks” and that the “public interest would be dramatically harmed” if the drug were removed from the market.
It also called the lawsuit “extraordinary and unprecedented.”
There is little legal precedent for a court to overturn an FDA approval of a drug.
However, some abortion rights advocates expected this decision from Kacsmaryk, a Trump appointee who earlier in his career represented a Christian conservative legal group, First Liberty Institute. The group sued the federal government challenging the part of the Affordable Care Act that required employers to provide free insurance coverage for birth control.
Biden said Friday that “the Court in this case has substituted its judgment for FDA, the expert agency that approves drugs.”
“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” Biden said.
The legal fight over abortion pills going forward may be complicated by a second ruling that came minutes after the Texas decision. In a separate case, a federal judge in Washington state issued a preliminary injunction barring the FDA from "altering the status quo and rights as it relates to the availability of mifepristone."
In that case, a coalition of Democratic attorneys general in February challenged the FDA’s regulations on mifepristone and asked the court to remove “unnecessary” restrictions that could limit access to it.
However, the ruling from the judge in Washington state applies only to the 18 states that sued.