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The Supreme Court Mifepristone Case Isn’t Just About Abortion

The issue of government agency omnipotence is reaching fever pitch in American politics.

Annual March For Life Held In Washington, D.C.
(Photo by Anna Moneymaker/Getty Images)

Is the Food and Drug Administration immune to challenges from the highest court? The solicitor general of the United States says yes. In Tuesday’s oral arguments before the U.S. Supreme Court in FDA v. Alliance for Hippocratic Medicine—“the abortion pill case”—Elizabeth Prelogar demurred in response to justices’ questions of who, if not the plaintiff doctors, could be permitted to contest FDA’s decisions regarding drug safety. 

FDA v. Alliance for Hippocratic Medicine has climbed the levels of the judicial system in the last year, bringing with it questions of federal agency overreach and the limits of standing. Those questions are now on the public tongue, too, due to the sensitive subject matter at hand: curtailing federal approval of mifepristone, the drug now responsible for the majority of abortions in the United States. After Tuesday’s oral arguments, a revocation of FDA approval looks unlikely: The court seemed to agree with the solicitor general that the plaintiffs, a group of doctors who cite conscientious objections to assisting in an abortion, have narrow grounds for challenging the drug’s use.

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But agency overreach, the unchecked ability of the FDA to approve and disapprove drugs as it sees fit, consequences notwithstanding, loomed large. Associate Justice Samuel Alito pushed the question repeatedly. 

“So your argument is that it doesn’t matter if FDA flagrantly violated the law, it didn't do what it should have done, endangered the health of women, it's just too bad, nobody can sue in court?” Alito said. “There’s no—there’s no remedy? The American people have no remedy for that?”

“The government has been routinely resisting standing because we think that that would essentially mean that any advocacy organization could say it opposes what the federal government is doing and so, therefore, has to devote resources to that opposition. If that were enough, then every organization would have standing and it would be a vast expansion of ordinary Article III principles,” Prelogar responded.

Drugs became the go-to method for the majority of women seeking abortions only in 2020. Mifepristone use was on the rise before the pandemic, but it was the strictures of lockdown that gave the FDA pretext to expand access to chemical abortifacients, under the guise of making “life-saving” medicine available in desperate times. Where once a woman had to have an in-person visit with a doctor before aborting, she could now receive the drug by mail after a telemedicine call. By the end of 2020, mifepristone abortions accounted for 53 percent of all abortions nationwide; just four years later, they comprise 63 percent.

The ability to mail this drug is significant for abortion regulation as well as for drugmakers’ bottom line. It is also significant in light of the Comstock Act of 1873, which prohibits the mailing of lewd or indecent materials, including those used for abortion. The abortion piece of Comstock was effectively rendered useless by the Supreme Court’s decision in Griswold v. Connecticut, but legal scholars say Dobbs may have changed that. One Texas district judge, Matthew Kacsmaryk, certainly believed so, and argued as much when FDA v. Alliance reached his desk. (The FDA itself remains immune to Comstock, as a federal agency that merely approves the abortion drugs for mailing but does not mail them. Danco Laboratories, mifepristone’s distributor, would be at risk.) There is also another reason mail-order abortion drugs are so consequential: The FDA’s own review of studies in which women were given the pill without seeing a doctor showed 7 percent more women visiting the emergency room for side effects.

The trouble with a mail-order kill pill is that unborn babies are not so easily gotten rid of. Women who take mifepristone often experience excruciating pain and profuse bleeding. These can hardly be called side effects, since a miscarriage is the purpose of taking the drug. While not all women who go to the ER need treatment, many do; it is not uncommon for women to need a “D&C,” or dilation and curettage, in which a doctor manually dilates her cervix to scrape her womb of pregnancy tissues and fetal remains, to prevent deadly hemorrhage. All of this does not top mifepristone’s intended purpose as a drug, which boasts dead subjects in 95 to 99 percent of uses.

The FDA fears granting this case standing would allow hundreds of organizations to sue the agency for its approval of various drugs, a prospect which is understandably concerning for the agency. The FDA has been caught in corruption in the past—allowing Purdue Pharma employees to draft the FDA’s own language in the approval of OxyContin, for example, or allowing Danco to cite a “<0.5%” adverse reaction rate to mifepristone on its label, when FDA knew the real rate was as high as 20 percent, or four times the complication rate of a surgical abortion. Due to the doctrine of sovereign immunity, however, pharmaceutical companies have been the ones to feel the burn. With the exception of the occasional scapegoat, the federal bureaucracy typically remains unscathed. No court, according to Tuesday’s hearings, has ever second guessed the FDA’s judgment about access to a drug. 

Alito’s questions are answered in the negative for now. The Administrative Procedure Act has previously been used to make such challenges to FDA judgment nearly impossible. But should the FDA be immune to such challenges, especially where the lives of mothers and children are at risk, is another question entirely.

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