The Supreme Court unanimously rejected a challenge on June 13 that was brought by a doctors’ group against the Food and Drug Administration’s (FDA’s) loosening of regulations of the abortion pill mifepristone, handing a win to the agency.
The court held that those challenging the status of the pill lacked the legal standing to do so.
The decision came two years after the court’s landmark 2022 ruling in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and returned the regulation of abortion to the states.
President Joe Biden quickly hailed the new decision, describing mifepristone as “safe and effective.”
He also criticized Republicans, saying their “attacks on medication abortion are part of … [an] extreme and dangerous agenda to ban abortion nationwide.”
Since Roe v. Wade was reversed, “Republican elected officials have imposed extreme abortion bans in 21 states, some of which include zero exceptions for rape or incest,” the president said in a written statement.
Medication abortions are reportedly lawful in 36 states and the District of Columbia.
A medication abortion generally involves the use of mifepristone, which blocks progesterone, a hormone, and misoprostol, which induces contractions. Misoprostol, which is widely available because it has many medical uses, wasn’t an issue in the current litigation. Also known as mifeprex and RU-486, mifepristone is made by Danco Laboratories.
Advocates for mifepristone said the current system by which the drug is provided is safe, while opponents said it puts women at risk by ignoring safety measures that used to be in place.
The Biden administration and pro-abortion groups warned that the Supreme Court’s eventual decision in the case could affect the drug’s availability.
The case is actually two appeals that the court consolidated—Food and Drug Administration v. Alliance for Hippocratic Medicine (AHM) and Danco Laboratories LLC v. AHM.
The Supreme Court case came after Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, an appointee of President Donald Trump, held in April 2023 that the FDA was wrong to approve mifepristone for public use in 2000. He said the FDA was under political pressure to get the pill on the market and then, after that, had deliberately dragged out judicial review of the drug for years.
Judge Kacsmaryk found the FDA had improperly lifted restrictions related to accessing the drug and issued a preliminary nationwide injunction retroactively staying the FDA’s approval.
In 2016, the FDA changed the drug’s official label, extending the cutoff for use from 49 days of gestation to 70 days. At the same time, the agency allowed the drug to be prescribed with only one in-person visit and halted the requirement that prescribers report nonfatal adverse events.
In 2021, the agency allowed patients to receive the drug by mail instead of having to pick it up in person from a specially certified health care provider.
Issues of Standing
During oral arguments at the Supreme Court on March 26, much of the discussion focused on legal standing, that is, the connection a litigant has to a controversy before the court.U.S. Solicitor General Elizabeth Prelogar told the justices that the Alliance for Hippocratic Medicine, whose member groups include physicians, lacked standing to challenge FDA regulations.
The agency has found the abortion pill to be “safe and effective” across five presidential administrations “and millions of Americans have used mifepristone to safely end their pregnancies.”
The other side “may not agree with that choice, but that doesn’t give them Article III standing or a legal basis to upend the regulatory scheme,” she said. Article III of the U.S. Constitution governs federal courts.
In the court’s opinion, Justice Kavanaugh recounted that several pro-life physicians and associations sued the FDA, arguing that the agency’s actions ran afoul of the federal Administrative Procedure Act.
“But the plaintiffs do not prescribe or use mifepristone. And FDA is not requiring them to do or refrain from doing anything. Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain,” Justice Kavanaugh wrote.
“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. Therefore, the plaintiffs lack standing to challenge FDA’s actions.”
Redress is available to the plaintiffs who challenge the FDA’s decision, but it is to be found in the policymaking process.
Although the challengers “have sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone,” Justice Kavanaugh wrote, under the Constitution “those kinds of objections alone do not establish a justiciable case or controversy in federal court.”
If a question is justiciable, it means that it can be assessed according to legal principles by a court.
The challengers did not show that the FDA’s “relaxed regulatory requirements likely would cause them to suffer an injury in fact,” Justice Kavanaugh wrote, and this means “the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
Instead, the challengers may bring their concerns to the president and the FDA through the regulatory process or the legislative process, or to their fellow citizens.
Plaintiffs Respond
At a news conference following the release of the opinion, Erin Hawley, senior counsel at the Alliance Defending Freedom (ADF), which represented the Alliance for Hippocratic Medicine, said she was disappointed by the ruling.“The FDA’s own label says that roughly one in 25 women who take this drug will end up in the emergency room and up to 7 percent will require surgery. Data cited by the FDA shows that hospitalizations increase about 300 percent with no in-person doctor visit,” she said.
“ADF and our clients will continue to advocate for women’s health and seek to restore common sense safeguards for abortion drugs. We’re hopeful that the FDA will be held to account for putting politics above women’s health.”
Dr. Ingrid Skop, vice president of the Charlotte Lozier Institute, is a practicing obstetrician-gynecologist with more than 30 years of experience.
“I have seen firsthand that mail-order abortion drugs harm my patients, both mothers and their unborn children,” Dr. Skop said in a written statement, criticizing that in-person doctor visits aren’t required.
“As a tragic result, I expect to see more women need blood transfusions, emergency surgery, and other drastic measures, and our emergency medical systems overwhelmed.”
