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Appeals court weighs FDA approval of abortion drug

Three-judge panel weighs FDA's 2000 approval of a drug commonly used in abortions

Packages of Mifepristone tablets are displayed at a family planning clinic. The U.S. Court of Appeals for the 5th Circuit on Wednesday heard arguments in the Food and Drug Administration’s approval and regulation of a the abortion drug mifepristone.
Packages of Mifepristone tablets are displayed at a family planning clinic. The U.S. Court of Appeals for the 5th Circuit on Wednesday heard arguments in the Food and Drug Administration’s approval and regulation of a the abortion drug mifepristone. (Anna Moneymaker/Getty Images photo illustration)

A three-judge panel that heard oral arguments Wednesday in a case challenging the Food and Drug Administration’s 2000 approval of a commonly used abortion drug seemed receptive to that challenge.

The U.S. Court of Appeals for the 5th Circuit, which heard arguments in a case brought by a group of conservative medical groups who oppose mifepristone, a drug used as part of the regimen for medication abortions and miscarriage management, seemed skeptical of the federal government’s defense of that drug’s approval. 

The judges were critical of government filings calling a district court decision against the FDA an “unprecedented judicial assault,” with Judge Jennifer Walker Elrod telling Sarah E. Harrington, deputy assistant attorney general for the Justice Department the remarks were “unusual.”

“Why not just focus on the facts of this case, rather than have this sort of ‘FDA can do no wrong’ theme,” asked Judge James C. Ho.

But Harrington said the agency “is charged with determining what is relevant for safety and efficacy, and it’s certainly not up to lawyers and judges to come in and say.”

Judge Cory Wilson, who, like Ho, was appointed by former President Donald Trump, interjected. 

“Well, if the FDA didn’t consider an important part of the problem, it is our role, correct, to go behind the FDA and determine whether what they did was arbitrary and capricious.”

The case, Alliance for Hippocratic Medicine v. FDA, is the first abortion case with major national implications since the Supreme Court overturned the national right to abortion under Roe v. Wade last June. 

A court ruling challenging the FDA’s authority to regulate drugs would also be precedent-setting, and the pharmaceutical industry has warned that could undermine the development and approval of new medications.

Harrington told Ho that an affidavit from former acting FDA Commissioner Janet Woodcock, served as “good evidence” the agency intended to comply with the final court decision.

The judges did not indicate when they would rule and are not under time constraints. The losing side is expected to appeal the decision to the Supreme Court.

Court arguments

Harrington argued that the medical groups should not have standing to challenge the FDA and their central arguments against the drug were time barred.

“They claim injury from speculative downstream effects of choices made by a chain of other people who are not parties to this lawsuit,” Harrington said, adding FDA’s approval of a drug does not require a provider to prescribe it or a patient to take it. 

She said that plaintiffs do not document being required to complete an abortion or treating a patient who has taken the drug for possible complications, or objecting to the use of the drug on religious grounds and still being required to administer it.

“None of the affidavits even allege that they themselves have had to participate in an abortion against their religious beliefs,” she argued, adding there is no “imminent risk” of harm in the past and it’s “purely speculative, whether it would happen in the future.” 

Ho asked Harrington about the government’s position on a physician’s objection to a 1986 law that requires hospitals that accept federal money to provide access to emergency health services.

Harrington said the law does not require a doctor to provide a procedure that violates a religious objection.

Both Harrington and Jessica Ellsworth, the lawyer representing Danco Laboratories, which makes mifepristone, said the plaintiffs also did not demonstrate how FDA’s changes to how mifepristone is prescribed or dispensed caused additional harm. In 2016, FDA expanded the use of mifepristone to 10 weeks of pregnancy, and allowed it to be prescribed via telehealth and by advanced practice practitioners. 

“There was not a single statement in any of the declarations before you that identifies a defendant who treated a patient after that patient received FDA-approved mifepristone through a telemedicine appointment,” said Ellsworth. The agency permanently removed its in-person dispensing requirement in January.

But Elrod expressed multiple concerns about telemedicine and questioned the oversight of prescribing and dispensing the drug “if it’s a mail business thing on the computer” and how it would allow screening for ectopic pregnancies.

Wilson, meanwhile, asked if the FDA considered that in relaxing in-person requirements, the drug could cross state lines and be prescribed from California to Mississippi. Elrod also asked whether mail delivery of the drug could violate state laws.

“It’s relevant, isn’t it, whether or not there should be an injunction, because if it’s violating other law… then we have to decide whether it’s appropriate to enter an injunction or not. And that’s one of the factors we would consider,” she said.

Erin Hawley, senior counsel for Alliance Defending Freedom, rebutted the government’s argument that the plaintiffs were not harmed by the drug’s approval and regulations.

Hawley pointed to language in court documents that said one of the doctors “cared for” patients, which meant she had been personally affected by completing unfinished abortions.

“If we’re going to parse her words, then that last phrase guarantees that she herself performed them. She wouldn’t know what was involved in those procedures if she were just talking about some colleague,” she said.

Elrod asked Hawley how specifically the plaintiffs defined the harm they allegedly experienced.

Hawley said that being “forced to be complicit” in a medication abortion is an “irreparable harm” and there was an “emotional harm” from the “heartbreaking toll” of treating women who had had an abortion.