Abortion Pill Showdown

Terry H. Schwadron

March 25, 2024

Tomorrow’s abortion pill showdown at the Supreme Court promises to be much more than a new front in the reproductive medicine war.

It’s an engineered attack on abortion, the Federal Drug Administration and its practices by a group that may not have proper legal standing and is building its arguments on pseudoscience.

The case due for hearing Tuesday is FDA v. Alliance for Hippocratic Medicine, an ad hoc group of anti-abortion doctors and others who came together last year to fight the distribution of mifepristine, one of two medicines used in about 60% of all abortions, The group sought out the federal district court of Judge Matthew Kacsmaryk, an anti-abortion campaigner and lawyer for Christian causes himself before joining the bench, who ruled that the FDA wrongly approved use of the drug 23 years ago, and wrongly allowed distribution by mail during the pandemic.

A federal appeals court partly overruled Kacsmaryk about the original clinical okay but upheld the portion that would block distribution by mail and not in person.  Distribution has continued during the appeals process.

Questions have included whether the plaintiffs had standing to file the challenge, whether there was sufficient evidence about any additional clinical trials needed (two cited studies have since been discredited), and a witness presented as a “doctor” whose advanced degree is a masters in theological studies, and over a time limit for challenge.

But upholding the portion that basically requires physical visits would have a huge impact nationwide, particularly as many red states have ruled abortion clinics and treatments illegal.  

The Arguments

It could be that even this conservative Supreme Court majority may steer clear of the details, as some argue. There is no real matter of law here about the drug.   

Instead, there is a question about the authority of a federal agency like the FDA to set procedures for distribution of the drug.

Basically, the appeals verdict said that the FDA should have mounted one big safety study rather than several smaller studies before allowing patients to forgo physical appointments — ignoring exigencies created under the covid emergency.

The FDA has never been required to make this kind of inquiry when approving any other drug. Upholding a requirement to do so could mean that thousands of medications would likely also fall short.

As things stand, mifepristone can be used up to the 70 days of pregnancy (up from 49 days at a capped dosage. There is a sister drug that usually is used with mifepristone that can be used alone, but is less effective. Any decision to return to pre-2016 protocols, in which the FDA reduced three required medical visits to one, would delay distribution for months as company would have to revise packaging and labels, recertify providers and the like.

A decision to extend abortion law by barring mifepristone would be the equivalent of declaring abortion illegal nationwide.

The irony is that an anti-abortion majority could be in the position to save the most popular abortion treatment in the country.

Where Does It Go?

The FDA argues that the appeals court was wrong, as was the original district court.

One out here is that no one among the plaintiff groups has been injured, and so the debate over whether the Alliance has standing remains open. At first, the Alliance said because mifepristone was not entirely tested, even after 20 years and millions of usages, some patients might end up in these doctors’ reluctant abortion care. They might feel injured if they are made to “feel complicit” in any resulting abortion.

The court could rule that the FDA met its requirement to review data before changing the rules because the agency reviews several other clinical study results involving tens of thousands.

In any event, the appeals court wanted the FDA to go through different procedures in the past, not the present, applying new rules about clinical trials to decisions made years ago. That prompted the pharmaceutical industry to file briefs in this case that argues that few if any of many thousands of other drugs approved in the past would meet the same standard.  If the FDA now must comply with more restrictive protocols and if those new rules apply retroactively to its past decisions, countless existing medications would immediately be subject to legal challenge.

But why stop at drugs. Why isn’t the same thing true for airline manufacture or arms production or child labor laws?

The issues presented here certainly underscore just how far individual judges or courts will go to stop abortions, even rewriting court precedents and procedures.

But it also comes at a time when Republican leadership is pressing for national legislation that would define life as the moment of conception, putting IVF help for births at risk anew, opening the door to contraceptive restrictions, and deepening divides around the country.

You might want to listen to these live arguments on the Internet.

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