Supreme Court seems skeptical on case that could end use of popular abortion drug

A challenge to the FDA’s approval of a popular abortion drug is in doubt after justices on the nation’s highest court seemed skeptical of plaintiffs standing to sue the regulatory agency.

The U.S. Supreme Court, on Tuesday, heard arguments from both sides of a lawsuit seeking to undo the FDA’s decades-old approval of the drug mifepristone, when justices seemed to think the lower courts had gone too far in accepting arguments brought by doctors that object to performing abortions.

“I’m worried that there is a significant mismatch in this case between the claimed injury and the remedy that’s being sought and that that might or should matter for standing purposes,” Associate Justice Ketanji Brown Jackson said.

The case comes after a group of antiabortion healthcare professionals sued the Food and Drug Administration, alleging the abortion drug’s original approval was based on flawed data. When the Alliance for Hippocratic Medicine brought their case to a court in Texas five months ago, U.S. District Judge Matthew Kacsmaryk was quick to agree with their position and was poised to revoke medical approval of mifepristone and prohibit its use nationally.

The Fifth Circuit later overturned most of Kacsmaryk’s order, but reversed rules the FDA had put in place for the drug in 2016 and 2021 which allowed it to be sent via the U.S. mail and to be taken outside of the presence of a medical provider.

Lawyers arguing on behalf of the plaintiffs contend, that even if they don’t give the drug to patients, its approval for use puts them at risk of having to treat a patient who might fall ill after taking it, which in turn might violate their religious beliefs.

Solicitor General Elizabeth Barchas Prelogar, arguing on behalf of the government, told the court that the plaintiffs don’t have to prescribe the drug, and therefore are not necessarily even subject to the regulations they were trying to overturn.

“They don’t prescribe mifepristone. They don’t take mifepristone, obviously. FDA is not requiring them to do or refrain from doing anything. They aren’t required to treat women who take mifepristone. FDA is not directing the women who take the drug to go seek out care from these specific doctors,” she said.

“And the Court has said in many cases that in a situation like that, when you are not the direct object of the agency’s regulation, it can be substantially more difficult to establish standing,” she said.

Lawyers for Danco, one of the companies that produces the abortion drug, told the court that allowing the challenge would upend the pharmaceutical industry as a whole, with any drug approved by experts at the FDA potentially subject to court challenge.

Jackson wondered at the fallibility of judges when it comes to matters of medicine, asking “what deference, if any, do courts owe the opinion of the expert agency concerning the safety and efficacy of drugs?”

The court will likely issue an opinion on the case in June.

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