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Maker of and supporters of mifepristone “push hard,” asking the Supreme Court to remove all “restrictions” which are intended to safeguard women

by | Nov 28, 2023

By Dave Andrusko

The headline to the story merely confirms what we already knew: ‘Biden admin urges Supreme Court to nix mifepristone restrictions.” But the real guts of the story comes immediately, in a photo caption: “Industry representatives have pushed back hard against the appeals court’s restrictions on mifepristone.” Surprise, surprise, those with a gigantic interest in the first of the two drugs that make up “medication abortions” are pulling out all the stops.

Background

Last November, the Alliance for Hippocratic Medicine challenged the FDA’s original approval of the drug which took place in 2000. Put briefly, the plaintiffs—five medical organizations and four doctors—contend that mifepristone is unsafe and that the F.D.A.’s approval process was flawed. It was heard by Judge Matthew Kacsmaryk.

Ground zero for the fast-moving case was Judge Kacsmaryk’s April 7 decision to suspend FDA approval of mifepristone. He accepted the argument of the Alliance for Hippocratic Medicine that the FDA had fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses. Judge Kacsmaryk delayed his ruling until higher courts could review the case. 

A subsequent ruling by a three-judge panel of the 5th Circuit decided not to challenge the FDA’s original approval of mifepristone, but did overturn the changes made in 2016, 2021, and 2023 which loosened the FDA’s original safeguards applied to mifepristone.

It left in place the original requirements that the drug be used only up to 7 weeks of pregnancy, including three physician visits, removes the ability for the drug to be mailed or dispensed by pharmacies, prevents non-physicians from administering the drug and reinstates the reporting requirements for non-fatal adverse events.

The pro-abortion Biden, of course, appealed to the Supreme Court. Meanwhile distribution of mifepristone continues unrestricted.

Kansteiner’s contribution was helpful:

Following similar campaigns mounted by industry players and biopharma trade groups, the United States’ Solicitor General has joined a chorus of voices calling on the Supreme Court to overturn an appeals court’s August ruling surrounding the abortion pill mifepristone.

If the lower court’s decision is allowed to stand, it could upend the regulatory process in the U.S. and pave the way for lawsuits questioning virtually any approved drug on the market, organizations like the trade group Pharmaceutical Researchers and Manufacturers of America (PhRMA) have argued in recent months.

Now, writing for the U.S. Food and Drug Administration, Elizabeth Prelogar is pressing SCOTUS to rethink the Fifth Circuit’s “unprecedented decision,” the Solicitor General said in a reply brief published late this month.

But there was still more industry pushback, including mifepristone-maker Danco Laboratories which

called on the High Court to overturn the appeals court’s verdict, arguing that “risks and confusion” stemming from the Fifth Circuit’s decision would unfairly fall upon women, teenage girls and the public health system.

“Denying review of the Fifth Circuit’s opinion would eviscerate the sovereign authority of states that have chosen to expand and protect access to medication abortion in their jurisdictions,” Danco’s legal team argued at the time.

In October, PhRMA and a plethora of industry players lodged amicus briefs pressing the Supreme Court to reverse the Fifth Circuit’s determination. If the ruling were allowed to stand, FDA approvals would become “mere precursors to litigation,” PhRMA said.

The Supreme Court has not said whether it will take the case, although odds are, it will. I would highly recommend, for a more in-depth examination of the 5th Circuit’s opinion and the issues it raises, that you read our Special Report on the Fifth Circuit’s opinion.  And for a look at where the various abortion pill cases stand, please see here.

Categories: Abortion Pill