The Supreme Court on Friday temporarily restored full access to a key abortion medication, giving itself more time to review a lower court decision that suspended approval of a pill used in more than half of all abortions in the United States.
The government and Danco Laboratories, manufacturer of the drug mifepristone, urged the court not to second-guess the expertise of the Food and Drug Administration, which relied on data from dozens of clinical trials when it approved the drug more than 20 years ago. Leaving the ruling in place, they said, will create confusion and uncertainty for abortion providers and have devastating consequences for the pharmaceutical industry’s ability to bring new drugs to market.
“If allowed to take effect, the lower courts’ orders would thwart FDA’s scientific judgment and undermine widespread reliance in a healthcare system that assumes the availability of mifepristone as an alternative to more burdensome and invasive surgical abortions,” Solicitor General Elizabeth B. Prelogar told the court in the government’s filing. “Those harms would be felt throughout the Nation because mifepristone has lawful uses in every State — even those with restrictive abortion laws.”
U.S. District Judge Matthew Kacsmaryk of Texas last week suspended approval of the drug. The U.S. Court of Appeals for the 5th Circuit on Wednesday refused to completely undo FDA approval of mifepristone for now, but reinstated limits on how patients obtain the drug and how late into pregnancy it can be used.
Those restrictions would have taken effect Saturday, the government said, if the court had not intervened.
Prelogar said the Supreme Court should extend a stay while the appeals court reviewed the merits of Kacsmaryk’s decision, but could also quickly schedule full briefing and oral argument to review the case before the court’s summer recess.
Erin Hawley, senior counsel with Alliance Defending Freedom, the conservative group behind the lawsuit, said in a statement Friday that the FDA “illegally approved chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades. The 5th Circuit rightly required the agency to prioritize women’s health by restoring critical safeguards, and we’ll urge the Supreme Court to keep that accountability in place.”
Alito, the justice designated to consider emergency petitions arising from the 5th Circuit, said Hawley’s group should file its response to the government by Tuesday. The full court will almost surely decide the outcome.
The 5th Circuit’s order is directly at odds with a separate ruling from a federal judge in Washington state who directed the FDA not to make any changes to the availability of mifepristone in 17 states and the District of Columbia, whose officials filed suit there. By contrast, the 5th Circuit panel reinstated restrictions prohibiting mailing of the drug directly to patients and rolls back the period of time in which it can be used from 10 weeks of pregnancy to seven weeks.
Prelogar’s petition said both the Texas judge and the 5th Circuit countermanded FDA’s scientific judgment and would unleash “regulatory chaos.”
“In 2000, FDA approved mifepristone for termination of early pregnancy based on the agency’s expert judgment that the drug is safe and effective,” she wrote. “FDA has maintained that scientific judgment across five presidential administrations, and it has modified the original conditions of mifepristone’s approval as decades of experience have conclusively demonstrated the drug’s safety.”
She noted: “Public health authorities around the world have likewise approved mifepristone, and the World Health Organization has included it on a list of ‘Essential Medicines.’”
She said the court of appeals judges “badly misread” documents about its safety and said the number of patients who might require emergency care after a medication abortion is “extremely low.”
Moreover, Prelogar wrote, “As of June 2022, only 28 deaths had been reported among the more than 5 million women who have taken mifepristone, and some of them had obvious alternative causes — including homicide, drug overdose, and other factors entirely unrelated to mifepristone.”
She said the group of antiabortion doctors who challenged the FDA’s approval of mifepristone in Kacsmaryk’s court should never have been granted legal standing, because their interests are not implicated.
“They neither take nor prescribe mifepristone, and FDA’s approval of the drug does not require them to do or refrain from doing anything,” Prelogar wrote. “Yet the Fifth Circuit held that the associations have standing because some of their members might be asked to treat women who are prescribed mifepristone by other providers and who then suffer an exceedingly rare adverse event. This Court has squarely rejected that statistical approach.”
Last June, the court majority in Dobbs v. Jackson Women’s Health Organization said it was attempting to “heed the Constitution and return the issue of abortion to the people’s elected representatives.”
Justice Brett M. Kavanaugh wrote that the goal was to remove the courts from the issue.
“After today’s decision, the nine Members of this Court will no longer decide the basic legality of pre-viability abortion for all 330 million Americans,” Kavanaugh wrote in a concurring opinion. “That issue will be resolved by the people and their representatives in the democratic process in the States or Congress.”
But the new challenge calls into question just that — the availability of abortion nationwide, as well as the authority of a government agency to decide on the safety and use of certain drugs.
In its filing Friday, mifepristone’s manufacturer said affirming the 5th Circuit would abandon the assurance of the court in Dobbs. “Allowing the Fifth Circuit’s opinion to stand eviscerates the sovereign authority of States that wish to expand and protect access to medication abortion in their jurisdictions,” wrote Jessica Ellsworth, the lead attorney for Danco.
The company was supported by amicus briefs from other companies.
GenBioPro, the only generic manufacturer of mifepristone, told the court it would be forced to halt operations under the 5th Circuit’s ruling, which overturned FDA regulatory actions beginning in 2016. GenBioPro received FDA approval for its generic application in 2019.
In a separate brief, the trade group Biotechnology Innovation Organization, industry executives and companies including the global giant Pfizer said the lower-court rulings would upend the FDA’s regulatory authority with repercussions far beyond abortion pills.
“Both courts … substituted their own idiosyncratic views of clinical benefit and safety for the legislatively required, gold-standard benefit-risk analysis performed by FDA’s medical and scientific professionals,” the industry argued.
Kavanaugh could be key to the court’s deliberations, as could Chief Justice John G. Roberts Jr.
Roberts was not among the court’s conservatives who voted to overturn Roe. In the Dobbs decision, he wrote that he was reluctant to deny a woman a “reasonable opportunity to choose” whether to end her pregnancy. Colleagues to his left and right, he wrote, “display a relentless freedom from doubt on the legal issue that I cannot share.”
Dobbs concerned constitutional questions. The current case is statutory — when to defer to the FDA’s expertise on the safe use of mifepristone — and has divided the justices before along familiar ideological lines.
The court’s consideration of the issue several years ago was with a different backdrop — the then-constitutional right to abortion — and with the FDA at the time opposing efforts to ease access to the drug.
In 2020, during the pandemic, U.S. District Judge Theodore D. Chuang of Maryland lifted the FDA requirement that a patient travel to a doctor’s office to receive mifepristone. He said that travel restrictions during the pandemic put a burden on those seeking the medication and that experience had shown the visits were unnecessary to safely prescribe the drug.
The Trump administration strongly objected. After a long delay, the court declined to undo Chuang’s order.
That brought a strong dissent from Alito and Justice Clarence Thomas. “If the FDA is right” that mifepristone should be picked up in a doctor’s office even if ingested by the patient at home — which was the FDA’s position at the time — “non-enforcement of the requirement risks irreparable harm.”
And Alito was critical of Chuang. “A District Court Judge in Maryland took it upon himself to overrule the FDA on a question of drug safety,” Alito wrote, saying Chuang disregarded the court’s guidance against “second-guessing of officials with public health responsibilities.”
In the closing days of the Trump administration, the government went back to the Supreme Court, and the justices reimposed the requirement.
Roberts wrote that he was deferring to the expertise of the government agency, as he had in other decisions about pandemic restrictions.
The question is whether Chuang and an appeals court “properly ordered the Food and Drug Administration to lift those established requirements because of the court’s own evaluation of the impact of the COVID-19 pandemic. I do not see a sufficient basis here for the District Court to compel the FDA to alter the regimen for medical abortion,” he wrote.
The court’s liberals objected. Justices Sonia Sotomayor and Elena Kagan said their colleagues were allowing the FDA to impose unfair restrictions.
“Of the over 20,000 FDA-approved drugs, mifepristone is the only one that the FDA requires to be picked up in person for patients to take at home,” Sotomayor wrote. She said the years of experience in women taking the drug early in pregnancy had shown its safety.
But the FDA restrictions, she said, were part of a pattern. “This country’s laws have long singled out abortions for more onerous treatment than other medical procedures that carry similar or greater risks.”
Now, the FDA, under the Biden administration, has done away with the requirement that patients pick up the drug from a doctor’s office or clinic and allows health professionals besides doctors to prescribe it.
And now it is conservative judges who say the FDA has not demonstrated that it properly considered the safety concerns in implementing its new regulations.
The cases are FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.
Perry Stein and Christopher Rowland contributed to this report.
