MoxBlog

Reproductive rights returned to the Supreme Court on Tuesday for the first time in nearly two years, as the justices heard oral arguments for in the high-stakes case FDA v. Alliance for Hippocratic Medicine.

The high court is considering whether to roll back access to mifepristone, a key abortion medication that is part of a two-drug regimen and used in more than 60 percent of U.S. abortions.

The Alliance for Hippocratic Medicine, a coalition of antiabortion doctors and others, is arguing that the Food and Drug Administration didn’t sufficiently consider safety concerns when it approved the drug in 2000 or when it removed some restrictions in 2016 and in 2021. The Justice Department, on behalf of the Biden administration, argues that the mifepristone opponents don’t have standing in the case because they have never prescribed the drug. Danco Laboratories, the drug’s manufacturer, also contends that a ruling in favor of those challenging the drug would have a chilling effect on the pharmaceutical industry.

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Here are five key exchanges from Tuesday’s oral arguments:

1. The government is arguing that the doctors who brought the case don’t have standing

JUSTICE CLARENCE THOMAS: General, if we agree with you on standing, could you give us an example of who would have standing to challenge … these FDA actions?

U.S. SOLICITOR GENERAL ELIZABETH B. PRELOGAR: They are 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.

Supreme Court Justice Clarence Thomas asked the first question cutting to the heart of the government’s case: Who has standing to challenge the FDA’s drug approval process for mifepristone?

Solicitor General Elizabeth B. Prelogar didn’t directly answer Thomas’s question, instead saying that the coalition of antiabortion doctors who brought the case don’t have standing. “They don’t prescribe mifepristone,” she said. “They don’t take mifepristone.” As such, Prelogar argued, these doctors “stand at a far distance from the upstream regulatory action they’re challenging.”

2. Who has standing to sue the FDA?

JUSTICE SAMUEL A. ALITO JR.: Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful, and maybe what they did was perfectly lawful, but shouldn’t somebody be able to challenge that in court?

PRELOGAR: I think that with respect to these regulatory changes, it’s hard to identify anyone who would have standing to sue.

One recurring line of question for the government was who exactly could sue the FDA. Justice Samuel A. Alito Jr. asked Prelogar to provide a more “specific” answer to Thomas’s question about who had standing to challenge the FDA. He asked whether the states that intervened in the case have standing. Prelogar said no.

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Alito then followed up with a series of hypothetical scenarios, all related to the question of who has standing to challenge the FDA. Prelogar called one of Alito’s questions speculative and ultimately answered, “I think that with respect to these regulatory changes, it’s hard to identify anyone who would have standing to sue.” Alito seemed unpersuaded by the argument, telling Prelogar: “It’s just too bad, nobody can sue in court. There’d be no remedy. The American people have no remedy for that.”

3. Can a 151-year-old law that prohibits the mailing of ‘obscene materials’ include materials used for abortions?

ALITO: Shouldn’t the FDA have at least considered the application of 18 U.S.C. 1461?

PRELOGAR: So I think that the Comstock provisions don’t fall within FDA’s lane.

The conservative justices repeatedly referenced the Comstock Act during the oral arguments, referring to a law that bans the mailing of “obscene” or “indecent” materials and includes provisions limiting access to abortion medication and contraceptives by mail.

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Conservatives have looked to the Comstock Act — named after Anthony Comstock — as an opportunity to block mail-order abortion medications such as mifepristone. The first mention of the 1873 law occurred during an exchange between Alito and Prelogar.

“Shouldn’t the FDA have at least considered” the applicability of the Comstock Act, Alito asked.

The “FDA was not affirmatively approving mailing in violation of Comstock, even if you interpreted it that way,” Prelogar responded. “And we don’t think it means what respondents suggest it means.”

The Comstock Act hasn’t been applied in nearly a century and is generally believed to be obsolete.

4. Who is responsible for determining whether the abortion pill is safe?

JUSTICE SONIA SOTOMAYOR: But the reality is, even if there is some increase in emergency room visits, the question of when that rises to a sufficient safety risk is up to the FDA, correct?

PRELOGAR: That’s right.

Another recurring line of questioning for the government and drug manufacturer was whether the FDA’s loosening of regulations on the drug has resulted in more frequent trips to emergency rooms.

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In a previous exchange with Alito, Prelogar acknowledged that some studies have noted more visits, but “that didn’t equate to additional serious adverse events and, in fact, [in] one of the studies, half of the women who went to the emergency room didn’t get any treatment at all.”

In her question, Sotomayor focused on whose responsibility it was to determine the safety of the drug. Prelogar argued that falls under the purview of the FDA, which she said Congress has entrusted the FDA to do.

5. Are the mifepristone opponents asking for too much?

JUSTICE NEIL M. GORSUCH: This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal government action. Thoughts?

ERIN HAWLEY, PLAINTIFF LAWYER FOR ALLIANCE FOR HIPPOCRATIC MEDICINE: I think it’s impracticable to raise a conscious objection, but even spotting that the district court remedy was perfectly appropriate.

Justice Ketanji Brown Jackson repeatedly asked whether the anti-abortion doctors are “entitled” to the remedy they are seeking, which is to prevent “anyone from having access to these drugs at all.”

She told Prelogar she worries that “there is a significant mismatch” in the case between the claimed injury and the remedy the doctors seek. “The obvious common-sense remedy would be to provide them with an exemption that they don’t have to participate in this procedure,” Jackson told Prelogar.

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If the doctors can lodge their objections, “isn’t that enough to remedy their issue?” she asked Erin Hawley, who is arguing on behalf of those challenging the medication.

“Do we have to also entertain your argument that no one else in the world can have this drug or no one else in America should have this drug in order to protect your clients?” Jackson asked.

Gorsuch interrupted the exchange between Jackson and Hawley to add that the Supreme Court asks parties “over and over again [to] provide a remedy sufficient to address the plaintiff’s asserted injuries and go no further.”

“This case seems a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule,” he said.

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