Updated May 17, 2023 - Health

Federal appeals court seems skeptical of FDA's abortion pill approval

Abortion rights activists rallied outside the U.S. Supreme Court in Washington, D.C., on April 14. Photo: Probal Rashid/LightRocket via Getty Images

A federal appellate court on Wednesday seemed skeptical of nearly every argument from the Biden administration as it defended the Food and Drug Administration's power to approve a widely used abortion pill.

Why it matters: The New Orleans-based U.S. 5th Circuit Court of Appeals could decide in the coming weeks to uphold a Texas federal court ruling that ordered the FDA to withdraw its authorization of mifepristone, used in medication abortion, and set a precedent that could diminish the agency's authority in regulating medical treatments.

  • The lower court ruling, issued by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, marked the first time that a court has ordered the FDA to withdraw its authorization of a drug that has been on the market for over two decades.
  • The Supreme Court last month temporarily blocked Kacsmaryk's decision while the 5th Circuit, known for its conservative lean, considers the case.

State of play: The three-judge panel that presided over the case included two Trump appointees, Judges James Ho and Cory Wilson, and one Bush appointee, Judge Jennifer Walker Elrod. All three have an anti-abortion history.

  • The court is likely to issue a final decision in the coming months.
  • Mifepristone is considered safe and effective by major medical groups, such as the American Medical Association, the American College of Obstetricians and Gynecologists, and the World Health Organization.

Details: Almost immediately after the Justice Department, on behalf of the FDA, began arguing that the anti-abortion groups that brought the case lacked standing, the judges began interrupting, seeming skeptical of the government's assertions.

  • When Sarah Harrington, the government attorney, called the case "unprecedented" in her opening her arguments, Ho cut her off to add that the FDA has previously been legally challenged and that the agency has taken drugs off the market.
  • Harrington said that the FDA, on its own accord, has removed drugs from the market, but added that there hasn't been another instance in which a court "has vacated FDA’s determination that a drug is safe to be on the market."

The DOJ said that the groups lack standing because they are not directly regulated by the FDA — which does not have the authority to regulate the practice of medicine — and because the damages they say they will suffer are speculative, as the Supreme Court has previously set that plaintiffs in a case need to show real impact to bring a lawsuit.

  • However, the judges questioned the reasoning, siding with the anti-abortion groups' argument that physicians have been forced to provide an abortion, as well as care for patients who have had complications from the procedure.
  • The DOJ responded that the rate of complications from mifepristone is less than 1% and that the FDA's approval of the drug does not inherently force a health provider to provide an abortion.

Wilson also challenged the DOJ, suggesting that when the FDA allowed patients to access mifepristone via mail, they should have taken the long-dormant Comstock Act, an 1873 law that made it illegal to mail what at the time was considered "obscene, lewd, lascivious," such as pornographic publications.

  • Harrington asserted that Congress gave the FDA the power to determine what drugs and treatments are considered safe and effective, not the responsibility to examine laws when evaluating medical products.

Between the lines: Legal experts have argued that it is not the FDA's job to consider federal laws when approving or authorizing treatments because they do not enforce them.

  • "FDA is charged with reviewing the science and determining whether drugs are safe and effective, and making safe and effective drugs available to the public," said Lorie Chaiten, a senior staff attorney with the ACLU's Reproductive Freedom Project.
  • "The government agency that is responsible for enforcing the Comstock Laws is the Department of Justice," Chaiten told Axios, adding that it "is not [the FDA's] job to determine the enforcement of a criminal statute."

Danco Laboratories, the manufacturer of the name-brand mifepristone that is also part of the case, debated with the judges whether pregnancy should be considered an illness.

  • The anti-abortion groups argue that the FDA had to consider a pregnancy an illness in order to expedite approval of mifepristone in 2000 through a process that they say is typically used for medications to treat life-threatening diseases.
  • The judges seemed to side with the anti-abortion groups' argument, with Ho asking, "When we celebrated Mothers’ Day ... were we celebrating illness?"
  • Danco's attorney responded and said that the FDA has in the past expedited approval for drugs that are not used for potentially fatal conditions and added that mifepristone has been deemed safe and effective numerous times since it was first approved.

Don't forget: A definitive ruling directing the FDA to get rid of its authorization of mifepristone would set a precedent allowing a single judge to have the final say in the U.S. drug approval process.

  • The agency is "under attack like never before," said FDA commissioner Robert Califf during a conference. "Indeed, our fundamental authority to regulate the safety and efficacy of products is being challenged."

What we're watching: Regardless of the outcome, the case is expected to return to the Supreme Court in its next term.

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