Supreme Court rejects challenge to abortion pill mifepristone, allowing drug to stay on the market

By: CNN

Posted: Jun 13, 2024 10:22 AM CDT
Updated: Jun 13, 2024 12:00 PM CDT

Mandel Ngan/AFP/Getty Images via CNN Newsource

By Tierney Sneed and John Fritze

(CNN) — The Supreme Court on Thursday rejected a lawsuit challenging the Food and Drug Administration’s approach to regulating the abortion pill mifepristone with a ruling that will continue to allow the pills to be mailed to patients without an in-person doctor’s visit.

The ruling is a significant setback for the anti-abortion movement in what was the first major Supreme Court case on reproductive rights since the court’s conservative majority overturned Roe v. Wade in 2022.

Justice Brett Kavanaugh wrote the opinion for a unanimous court.

The court ruled that the doctors and anti-abortion groups that had challenged access to the drug did not have standing to sue. Though technical, the court’s reasoning is important because it might encourage other mifepristone challenges in the future.

“We recognize that many citizens, including the plaintiff doctors here, have sincere concerns about and objections to others using mifepristone and obtaining abortions,” Kavanaugh wrote. “But citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities – at least without the plaintiffs demonstrating how they would be injured by the government’s alleged under-regulation of others.”

The challenge to the drug had been vehemently opposed by the pharmaceutical industry, which warned that a ruling that second-guessed the regulations for mifepristone could open the door to legal challenges targeting all sorts of medications.

Under the Constitution, Kavanaugh wrote, “a plaintiff’s desire to make a drug less available for others does not establish standing to sue.”

“Citizens and doctors who object to what the law allows others to do may always take their concerns to the Executive and Legislative Branches and seek greater regulatory or legislative restrictions on certain activities,” he wrote.

Much of Kavanaugh’s opinion covered the various legal thresholds a plaintiff must reach to make it appropriate for courts to intervene in a dispute. Turning to the anti-abortion doctors and medical groups that sued the federal government over the current regulatory regime for the drug, Kavanaugh wrote that the plaintiffs suffered neither the monetary nor the physical injuries that could have established standing. He noted that federal law already protects individual health care providers who have objections to performing abortions for moral reasons.

“In short, given the broad and comprehensive conscience protections guaranteed by federal law, the plaintiffs have not shown – and cannot show – that FDA’s actions will cause them to suffer any conscience injury,” Kavanaugh wrote.

Justice Clarence Thomas wrote a concurrence to bring up other issues he had with the anti-abortion groups’ standing claims.

Attorney General Merrick Garland said that the Justice Department was “gratified” that the ruling “ensures that mifepristone remains available for women across the country on the terms approved by the Food and Drug Administration.”

Danco, a mifepristone manufacturer that had intervened to also defend access to the drug, said it was “pleased with the Supreme Court’s decision in this incredibly important case.”

The ruling, Danco spokesperson Abigail Long said, “maintained the stability of the FDA drug approval process, which is based on the agency’s expertise and on which patients, healthcare providers and the US pharmaceutical industry rely.”

“The decision also safeguards access to a drug that has decades of safe and effective use,” Long said in the statement.

The Alliance Defending Freedom, a conservative legal group that brought the lawsuit on behalf of the anti-abortion doctors, said it was “disappointed that the Supreme Court did not reach the merits of the FDA’s lawless removal of commonsense safety standards for abortion drug,” while alluding to the fact that the legal fight over the rules could continue with other plaintiffs.

Ingrid Skop, an anti-abortion OB-GYN and member of one of the medical groups suing the FDA, said it was “deeply disappointing that the FDA was not held accountable today for its reckless decisions.”

Originated in Texas with Trump-appointed judge

At the outset of the case, the anti-abortion doctors and medical organizations who challenged the FDA rules sought to pull mifepristone off the market entirely, arguing it was unsafe – a claim that has been refuted by mainstream medical organizations.

That effort came against a backdrop of conservative state laws that severely limited abortion in much of the country. As those bans helped propel the demand for medication abortion, mifepristone became a logical target for the anti-abortion movement. Medication abortions account for nearly two-thirds of all abortions in the US, according to some estimates.

A federal judge in Texas nominated by former President Donald Trump, Matthew Kacsmaryk, sided with the anti-abortion groups, but his ruling never went into effect.

The 5th US Circuit Court of Appeals reversed part of that ruling, holding the drug’s two-decade-old underlying approval would stand. But the appeals court sided with the doctors who challenged subsequent decisions by the agency that expanded access to the drug, including the ability to dispense it through the mail.

None of those lower court rulings went into effect because the Supreme Court intervened last year and ordered that the status quo around mifepristone remain in place until the justices reviewed the case. The Supreme Court heard arguments in March.

In the meantime, a group of GOP-led states intervened in the case at the trial judge-level, signaling that the legal fight over abortion pill access could continue even as the Supreme Court has rejected the lawsuit brought by the anti-abortion doctors.

Steve Vladeck, a CNN Supreme Court analyst and professor at the University of Texas School of Law, said that Thursday’s ruling “doesn’t cut off the possibility of future challenges to mifepristone,” as he pointed to the efforts by those Republican states.

“But the reasoning of the case should make those challenges less likely to succeed, because those plaintiffs (and others) will have a hard time showing that they were harmed by the FDA’s actions,” Vladeck said.

The FDA approved mifepristone in 2000 as part of a two-drug regimen to end a pregnancy. Over the course of two decades, the agency loosened restrictions it initially placed on the drug’s use. In 2016, it allowed women to take the drug later into a pregnancy, to 10 from seven weeks of gestational age. It also permitted non-physicians, such as nurse practitioners, to prescribe it. During the Covid-19 pandemic, the FDA announced it would no longer enforce the in-person dispensing requirement.

Last year, after the doctors’ lawsuit was filed, the FDA formalized that decision, allowing the drug to be dispensed through the mail.

Both the FDA and several medical groups, including the American Medical Association, told the Supreme Court that mifepristone is safe.

But the doctors, many of whom have long been associated with the anti-abortion movement, claimed that they faced the risk of being forced to treat patients dealing with complications from the drug, such as heavier-than-expected bleeding. They claimed that triaging those women had a substantial impact on their practices. And some said they had been called on to perform post-medication abortion procedures they said violated their beliefs.

At the Supreme Court hearing earlier this year, several justices — including members of the conservative bloc – expressed doubt that the doctors had overcome a procedural threshold known as standing, which requires plaintiffs to show that they had been harmed by the government’s actions.

None of the doctors who submitted declarations to a lower court actually prescribe mifepristone and none pointed to an instance when they were personally required to complete an abortion for a patient who had complications after taking the drug.

The lead medical group in the suit, the Alliance for Hippocratic Medicine, was incorporated in Amarillo, Texas, months before it filed the lawsuit – allowing it to choose a court where it was guaranteed to be assigned to Kacsmaryk, who was appointed to the bench by former President Donald Trump.

The Biden administration, along with a mifepristone manufacturer that intervened to defend the FDA, argued that since the anti-abortion doctors were not prescribing the drug, it wasn’t appropriate for them to challenge the regulations.

The decision landed in the middle of a presidential election that has already been heavily swayed by the Supreme Court’s abortion jurisprudence. The 2022 ruling in Dobbs v. Jackson Women’s Health Organization ended the constitutional right to abortion that Roe established in 1973. The decision prompted conservative states to enact strict limits on the procedure, which prompted additional litigation and helped rally Democrats. President Joe Biden has repeatedly blasted the decision on the campaign trail this year.

The mifepristone appeal was one of two abortion cases the high court was considering this month. The other deals with a strict ban on the procedure in Idaho. The Biden administration sued the state over that prohibition, arguing that a federal law requires hospitals that receive Medicare funding to provide stabilizing care in emergency rooms, including abortions, when the health of the pregnant woman is at stake.

This story has been updated with additional details.