Supreme Court rules in abortion medication case, finds group lacked standing to challenge FDA approval

The Supreme Court on Thursday ruledagainsta challenge to the Food and Drug Administration’s (FDA) regulatory approval process of the abortion drug mifepristone, in the latest abortion case since the landmark decision in 2022 that overturned Roe v. Wade. 

In a victory for the Biden administration and abortion rights supporters, the high court gave a unanimous decision that challengers to the FDA lacked standing to sue the government. 

‘Under Article III of the Constitution, a plaintiff’s desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs’ other standing theories suffice,’ Justice Brett Kavanaugh wrote, who authored the unanimous opinion.

‘The plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone,’ he said. ‘But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court.’ The case was remanded back down to the Fifth Circuit consistent with the Court’s opinion.

The case stemmed from a set of lawsuits filed by a group of health care associations, Alliance for Hippocratic Medicine, who claimed that the drug has a high rate of complications. 

Erin Hawley, counsel for the civil rights firm Alliance Defending Freedom, who argued the case against the FDA, said, ‘We are disappointed that the Supreme Court did not reach the merits of the FDA’s lawless removal of commonsense safety standards for abortion drugs. ‘

‘Nothing in today’s decision changes the fact that the FDA’s own label says that roughly one in 25 women who take chemical abortion drugs will end up in the emergency room — a dangerous reality the doctors and medical associations we represent in this case know all too well. The FDA recklessly leaves women and girls to take these high-risk drugs all alone in their homes or dorm, without requiring the ongoing, in-person care of a doctor,’ she said. 

‘While we’re disappointed with the court’s decision, we will continue to advocate for women and work to restore commonsense safeguards for abortion drugs — like an initial office visit to screen for ectopic pregnancies. And we are grateful that three states stand ready to hold the FDA accountable for jeopardizing the health and safety of women and girls across this country,’ she said.

The Supreme Court said that the group couldn’t prove that the FDA’s relaxed rules would have caused them injury, enough to give them standing to sue.

‘Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions,’ Kavanaugh said. 

‘The plaintiffs may present their concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the legislative process. And they may also express their views about abortion and mifepristone to fellow citizens, including in the political and electoral processes,’ he wrote.

In March, the justices heard about 90 minutes of arguments about federal government regulations since 2016 that made access to mifepristone easier, including access by mail.

In overturning Roe v. Wade in June 2022, the Supreme Court ruled in Dobbs v. Jackson Women’s Health Organization that the U.S. Constitution does not guarantee the right to an abortion and that the matter may be decided by the states.

In the aftermath, 14 states have banned abortion at all stages of pregnancy, with some exceptions, and two others have banned abortion once a fetal heartbeat is detected, which is at around six weeks of gestation. 

Mifepristone is taken along with misoprostol, and the two-drug combination is known as medication abortion or the ‘abortion pill.’ 

Lower courts concluded the federal agency did not fully consider the potential health risks to women when revising regulations for mifepristone beginning in 2016. Those revisions — last updated in 2023 — include reducing the recommended dose, allowing use of the drug up to 10 weeks of pregnancy (from seven weeks), approving a generic version and permitting it to be mailed (eliminating in-person doctor visits), among other measures.

The Biden administration and the maker of mifepristone asked the Court to reverse an appellate ruling that would cut off access to the drug through the mail and impose other restrictions, even in states where abortion remains legal. 

The restrictions would have included shortening the time during which mifepristone can be used in pregnancy from the current 10 weeks to seven weeks.

Data from the Guttmacher Institute research group says nearly two-thirds of all abortions in the U.S. in 2023 relied on mifepristone. About six million women have used the drug since its approval 24 years ago.

Abigail Long, a spokesperson for Danco, manufacturer of the drug said, ‘We are pleased with the Supreme Court’s decision in this incredibly important case.’ 

‘By rejecting the Fifth Circuit’s radical, unprecedented and unsupportable interpretation of who has standing to sue, the justices reaffirmed longstanding basic principles of administrative law,’ Long said.

‘In doing so, they 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,’ she said. 

‘We thank the Court for its careful analysis and remain committed to developing and bringing to market safe and effective products in this crucial area of public health.’

Justice Clarence Thomas, in a concurring opinion, highlighted his concerns with ‘associational standing’ raised in the case.

‘The Alliance’s attempted use of our associational-standing doctrine illustrates how far we have strayed from the traditional rule that plaintiffs must assert only their own injuries. The Alliance is an association whose members are other associations. None of its members are doctors. Instead, the Alliance seeks to have associational standing based on injuries to the doctors who are members of its member associations. Thus, the allegedly injured parties — the doctors — are two degrees removed from the party before us pursuing those injuries,’ he said.

Attorney General Merrick Garland praised the unanimous ruling Thursday saying, ‘As I said the day Dobbs was decided, women who reside in states that have blocked access to comprehensive reproductive care must remain free to travel to states in which that care is lawful.’ 

‘Under the First Amendment, individuals must remain free to inform and counsel each other about the reproductive care that is available across state lines. And, as the Office of Legal Counsel has concluded, the Comstock Act does not prohibit people from mailing mifepristone or misoprostol when they do not intend the recipient to use those drugs unlawfully,’ he said. 

‘For more than two decades, and across five presidential administrations, millions of Americans have relied upon FDA’s expert judgment that mifepristone is safe and effective for termination of early pregnancies. Today, more than half of those who choose to terminate their pregnancies rely on mifepristone to do so,’ he said.

Garland said he is ‘proud’ of the Justice Department lawyers ‘for vigorously defending the FDA’s expert judgment about the safety and efficacy of a medication that women have relied upon for more than twenty years.’

‘But our work does not end today. The Department will continue to work tirelessly to protect and advance reproductive freedoms under federal law,’ he said.