Understanding the current Supreme Court abortion case.

in fda •  6 months ago 

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The case is FDA vs. Alliance for Hippocratic Medicine. The reporting on it is bad even by normal media standards. Most articles don’t give the name of the case or explain the legal issues in any meaningful way, focusing only on the Justice’s questioning and the possible effects of the decision.

So here’s an attempt to make it coherent while being reasonably brief.

The drug at issue: Mifepristone was originally approved by the FDA for abortions in 2000, and more than half of abortions now use the drug. In 2016 the FDA expanded its use from 7 week into pregnancy to 10 weeks, reduced the number of required in-person clinical visits from three to one, and allowed certain non-physician healthcare providers licensed to prescribe and dispense drugs under their state’s law to prescribe and dispense mifepristone. In 2021, because of Covid, the FDA eliminated the in-person dispensing requirement. Mifepristone can now be prescribed via telemedicine and shipped to the pregnant woman for in-home use.

The FDA’s relaxation of restrictions is the subject of the lawsuit, with Alliance for Hippocratic Medicine – a group of anti-abortion healthcare providers, it appears – alleging they violated the law in their rule-making process.

Note: Whether or not we like a particular outcome, it’s important that bureaucratic agencies follow the law in their rulemaking (this is primarily the Administrative Procedure Act). If they don’t, the rule should be struck down (the end does not justify the means). If the agency really thinks a rule is necessary, they should follow the proper procedure.

The Hippocratic Alliance aren’t sticklers for procedure, but the claim that the FDA did not follow the law in its rulemaking is the legal ground it could find for trying to eliminate or limit access to mifepristone. Particularly, their concern is that women in states that severely restrict abortion can get a telemedicine consult, receive mifepristone through the mail, and secretly have an abortion in violation of state laws.

But if successful, the rollback of FDA regulations would also prohibit women in states that allow abortion from receiving mifepristone through the mail. This is, I’m sure, from their perspective a desired side-benefit. But it’s also deeply concerning to abortion rights supporters. Apparently, some of the SCOTUS justices were bothered by that, too. While they might sympathize with a state’s effort to prevent abortions in its own state, they seem dubious that nationwide restrictions on mifepristone are appropriate. (And, note, the case was not brought by a state, but by healthcare providers; more on that below).

I haven’t read closely enough to have an opinion on whether or not the FDA followed the law in their rulemaking or not.

But the Federal District Court ruled that the FDA had been “arbitrary and capricious” (a legal term of art) under the Administrative Procedure Act, extending even to the FDA’s original 2000 approval of mifepristone. The 5th Circuit Court reversed the ruling so far as the original approval of the drug but upheld the ruling against the FDA’s later rule changes.
The appeal to the Supreme Court seeks to overturn the 5th Circuit’s ruling against the FDA.

But….to have standing to bring a lawsuit, someone has to be able to claim injury. This is a threshold issue. Even if the FDA truly acted arbitrarily and capriciously, if you are not harmed by their action, you cannot bring a lawsuit against them. The District Court and 5th Circuit agreed that the Hippocratic Alliance had standing, but part of the FDA’s appeal to the Supremes is that they don’t.

So what injury does the Hippocratic Alliance claim? I need to quote here (from the FDA’s brief), because I can’t summarize neatly. Some “women who take mifepristone will experience adverse events or require surgical abortions…and that some of the [Alliance’s] members are likely to treat women who experience such adverse events . . . [and] doctors who treat such patients may provide care that violates their consciences, may be ‘forced to divert time and resources away from their regular patients,’ and may be ‘expose[d] *** to greater liability and increased insurance costs.’”

I’m not a lawyer. I don’t know if that’s a good legal argument for standing or not. I think hypotheticals sometimes pass muster and sometimes don’t, presumably based on how plausible/likely the justices think they are.

If the Court decides these health care providers have standing, then they will rule on the substance of the case. If they decide they do not, they will throw out the whole case, and the FDA regulations will remain in place.

Because lawyers will sometimes throw everything at the wall to see what sticks, the Hippocratic Alliance also raised the issue of the Comstock Act, a 19th-century law prohibiting sending various “immoral” things through the mail, including drugs used for inducing an abortion. This seems, to me, to be a more direct challenge, but apparently it’s somehow more of a secondary issue. Again, I am not a lawyer (and I’m only willing, for the moment, to put just a small amount of effort into this issue).

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