FDA v. Alliance Hippocratic Medicine (23-235)

argument 23-235

FDA v. Alliance Hippocratic Medicine

Supreme Court of the United States 1h 32m 8 speakers 8 chapters transcribed 8 days ago official recording ↗

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What is the core argument about the FDA’s authority to approve mifepristone?

John G. Roberts 0:00

We will hear argument this morning in case twenty three two hundred and thirty five, the Food and Drug Administration versus Alliance for Hippocratic Medicine and the Consolidated Case. General Piliger.

Elizabeth B. Prelogar 0:11

Mr. Chief Justice, and may it please the court. FDA approved mithopristone based on the agency's scientific judgment that the drug is safe and effective. It's maintained that judgment across five presidential administrations, and millions of Americans have used mithopristone to safely end their pregnancies. Respondents may not agree with that choice, but that doesn't give them Article III standing or a legal basis to upend the regulatory scheme. Mm. At the outset, respondents lack standing. They now concede they can't rely on a statistical theory of injury like the lower courts did. Instead, they have to identify a specific doctor who faces imminent harm. But their theories rest on a long chain of remote contingencies.

Elizabeth B. Prelogar 0:53

Only an exceptionally small number of women suffer the kind of serious complications that could trigger any need for emergency treatment. It's speculative that any of those women would seek care from the two specific doctors who asserted conscience injuries, and even if that happened, federal conscience protections would guard against the injury the doctors face. And there's no basis to conclude that any of that would be traceable to the incremental changes that FDA made in twenty sixteen and twenty twenty one, as opposed to the availability of mithopristone in general. Respondents' theories are too attenuated as a matter of law, the court should say so and put an end to this case. If the court reaches the merits, FDA's actions were lawful.

Elizabeth B. Prelogar 1:31

The agency relied on dozens of studies, involving tens of thousands of women. Respondents don't identify any evidence that the agency overlooked. They just disagree with the agency's analysis of the data before it, but that doesn't provide a license to authorize judicial second guessing of the agency's expert judgments. Finally, on remedy. The relief entered below would severely disrupt the federal system for developing and approving drugs, harming the agency and the pharmaceutical industry. It would also inflict grave harm on women across the nation. Rolling back FDA's changes would unnecessarily restrict access to Mythopristone with no safety justification. Some women could be forced to undergo more invasive surgical abortions, others might not be able to access the drug at all, and all of this would happen at the request of plaintiffs who have no certain injury of their own.

Elizabeth B. Prelogar 2:22

The court should reject that profoundly inequitable result. I welcome the court's questions.

Clarence Thomas 2:28

Uh General, if we agree with you on standing, could you give us an example of who would have standing to challenge to uh uh challenge these uh FDA actions?

Elizabeth B. Prelogar 2:43

As a general matter, we've seen lawsuits in the past that are brought by, for example, prescribing physicians or patients who want greater access to a drug. Sometimes we've seen theories of competitor standing where a competing drug manufacturer might sue and claim that FDA's approval of a drug creates a competitive harm or in or injury in that sense. Uh you know, Justice Thomas, I think that if the question is whether there would be individuals who generally oppose abortion who would have standing and want to challenge FDA's actions, the answer to that is no. But the reason is because those people aren't regulated in any relevant way under FDA's decisions here. You know, take these respondent doctors.

Elizabeth B. Prelogar 3:20

They don't prescribe mifepristone, they don't take myfopristone, 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. And so they stand at a far distance from the upstream regulatory action they're challenging. And the court has said in 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.