US Supreme Court hears oral arguments on abortion drug mifepristone

On Tuesday, March 26, the U.S. Supreme Court heard oral arguments in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, part of a legal challenge to the FDA’s studies and approval of the drug mifepristone. Mifepristone and misoprostol are used in a two-drug regimen for medication abortions. A ruling is not expected until June, when the court adjourns for the summer. The outcome could lead to the medication being severely restricted, including in states where abortion is legal. Abortion is banned or severely restricted in 21 U.S. states. 

FDA’s mifepristone history

Mifeprex, the patented version of mifepristone, was approved by the FDA in 2000. At that time, it could be taken up until seven weeks of pregnancy. In 2011, the FDA began a Risk Evaluation and Mitigation Strategy program that required prescribers to be certified to dispense the drug. In 2016, the FDA approved the drug for patients up to 10 weeks of pregnancy. In 2019, mifepristone, the generic of Mifeprex, was approved by the FDA. In 2020, because of the COVID-19 pandemic, mifepristone was approved to be dispensed by mail via telehealth. A year later, the FDA approved the sale of the drug in certified pharmacies. In June 2022, the Supreme Court overturned Roe v. Wade, and five months later the FDA’s approval of the drug was challenged in the case Alliance for Hippocratic Medicine v. FDA.

In February 2024, the Guttmacher Institute released a report of findings that medication abortions comprised 63% of all abortions in the nation in 2023, up 10% from 2020.

How we got here

In April 2023, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a decision that suspended the FDA’s 23-year-old approval of mifepristone along with subsequent rules governing the use of the medication. The U.S. Department of Justice appealed the decision to the U.S. Court of Appeals for the 5th Circuit.

A few days later, the appeals court issued a ruling that upheld Kacsmaryk’s decision regarding the rules and reinstating earlier restrictions on the dispensing and use of the drug, such as the legality of sending the drug through the mail, but did not suspend the FDA’s approval of the drug. 

The next day, the Justice Department announced it would seek emergency relief from the U.S. Supreme Court to protect access to mifepristone. A federal appeals court then issued a temporary stay, leaving the abortion medication on the market with its pre-2016 restrictions in place, limiting who can prescribe the medication and what pharmacies can dispense it.

Mifepristone has been determined to be safe in numerous scientific studies and has been used by over 5 million patients in the U.S. 

“GenBioPro urges the Supreme Court to reverse the Fifth Circuit’s ruling, protect the regulatory authority of the FDA, and safeguard access to this critical medication for millions of patients across the country who rely on it,” Evan Masingill, the CEO of GenBioPro, the manufacturer of generic mifepristone, said in a statement. 

“This suit, brought by extreme, anti-abortion special interest groups, is a baseless attack aiming to undermine science and access to a safe and effective medication,” Masingill said, adding that a ruling against the FDA could stifle pharmaceutical innovations and put the status of other approved drugs at risk. 

Reproductive rights leaders weigh in

U.S. Solicitor General Elizabeth Prelogar, arguing on behalf of the FDA, spent much of her argument explaining to the justices how deeply the FDA has studied the medication. 

Following oral arguments, reproductive rights leaders said the lawsuit was just another attempt by anti-abortion groups to end access to abortion care.

“Mifepristone is safer than Tylenol, but that hasn’t stopped anti-abortion extremists from lying about it to block even more Americans from the abortion care they need,” Mini Timmaraju, the president and CEO of Reproductive Freedom for All, said in a statement.

Pro-abortion rights groups in Wisconsin have been battling in court since Roe was overturned. A lawsuit filed by Gov. Tony Evers and Attorney General Josh Kaul has slowly wound its way through the courts and is expected to land in front of the state Supreme Court soon. At present, abortion medication is available at three Planned Parenthood clinics, but the state currently does not allow the medication to be sent to patients through the mail.

“Mifepristone is safe, effective, and has been used by more than 5 million people in the United States for abortion and miscarriage care since the FDA approved it more than 20 years ago,” Michelle Velasquez, chief strategy officer of Planned Parenthood of Wisconsin said in a statement sent to the Wisconsin Independent.

Possible outcome

According to reporting by Law Dork’s Chris Geidner, it seems unlikely that the Supreme Court will limit access to mifepristone. 

Most of the justices on both ideological sides of the court called into question whether the anti-abortion doctors who filed the initial lawsuit could prove that they would be harmed by the FDA authorization, that is, whether the Alliance and other original plaintiffs have standing to challenge mifepristone’s approval.

If the court rules that the respondents in the current case do not have standing, it can dismiss the case without ruling on the FDA’s authorization of mifepristone. Prelogar warned during oral arguments that a successful challenge to the FDA’s approval of drugs would go beyond mifepristone.

“It harms the agency, which had the federal courts come in and displace the agency’s scientific judgments,” Prelogar said. “It harms the pharmaceutical industry, which is sounding alarm bells in this case and saying that this would destabilize the system for approving and regulating drugs. And it harms women who need access to medication abortion under the conditions that FDA determined were safe and effective.”