As the clock ticked down to the last day to act on Friday, U.S. Supreme Court Justice Samuel Alito issued a temporary administrative stay.

His brief order granted approval, for now, of U.S. Solicitor General Elizabeth Prelogar's compelling 47-page Application [PDF] filed on behalf of the Federal Government, seeking an administrative stay on the entirety of the controversial effort by an activist Donald Trump-appointed judge in Texas who imposed a nationwide ban on the FDA-approved abortion pill, mifepristone.

The temporary administrative hold, keeping the status quo in place only through Wednesday, is meant to allow the full Court time to decide the broader request for a stay from both the Government and a manufacturer of the popular abortion medicine. The Solicitor General asked the Court to issue "a stay pending the consideration and disposition of [the FDA's] appeal to...the Fifth Circuit and, if the Court of Appeal affirms, pending the timely filing of a petition for a writ of certiorari and any further proceedings" before the Supreme Court.

In other words, please keep the status quo not only for the the FDA's science-based original approval issued in 2000 but also for the FDA's scientific decisions, made between 2016 and 2023, to better facilitate availability, distribution and safe use of mifepristone. The Solicitor General has asked for that status quo to remain in place until the U.S. Fifth Circuit Court of Appeals has actually heard full argument in the appeal of the ruling by Judge Mathew Kacsmaryk (the far-right U.S. District Court judge who hears every federal case filed in its Amarillo, TX branch) and then, if needed, throughout any additional appeals made to SCOTUS on the rulings of both lower courts.

While the matter of seeking a temporary stay, pending appeals, will now be decided by the same U.S. Supreme Court, whose right-wing majority, in Dobbs v. Jackson's Women's Health Org., overturned the Court's 50-year old landmark reproductive rights decision in Roe v. Wade last year, Prelogar parried the Court's anti-abortion bias by arguing that the stakes in this case are, by no means, confined to questions only about the approval and use of mifepristone...

The Government's Application argues that the Fifth Circuit ruling last Thursday ignored controlling Supreme Court precedents when it incorrectly held that the physician/respondents, seeking to ban mifepristone in the case, had the required legal standing to bring it in federal court in the first place. None of those doctors actually use or prescribe the drug. That means they are not personally harmed by the FDA's approval. And that mandates dismissing the case in its entirety because, under long-established high court precedent, federal courts lack jurisdiction to decide the substantive issues raised by anyone who lacks the requisite standing.

The Solicitor General also argues the three-judge panel of Republican appointees on the Fifth Circuit (two appointed by Trump and one tapped by George W. Bush) badly misread the case record when handing down its hastily drafted 42-page order just hours after the lengthy motion for a stay, opposition to it and reply briefs had been filed.

For example, the Government alleges that the appellate court reached an altogether inaccurate conclusion about a section of the Patient Agreement Form included with the two-drug cocktail used in the majority of U.S. abortions. The Form states that "in about 2 to 7 out of 100 women who use [mifepristone and misoprostol]...the treatment will not work."

From that phrase, the 5th Circuit panel incorrectly concluded that "it's statistically certain that hundreds of thousands of women [who use mifepristone] will need emergency care".

In truth, that section of the form says nothing about "emergency care". It simply informs patients that between 2% and 7% of mifepristone users may ultimately need to undergo a surgical abortion if they still desire to end a pregnancy. Cases of serious adverse reaction to the pharmaceutical procedure requiring emergency care are, in fact, extraordinarily rare. Many more die from the use of Tylenol or Viagra than from mifepristone and its companion drug misoprostol.

The controlling federal statute "does not require [the] FDA to only approve drugs when they are without risk --- no drug is," Prelogar noted. Instead, the FDA is required to consider whether "the expected therapeutic gain justifies the risk entailed by its use."

Referencing an attached Declaration from the FDA, the Solicitor General argued that, if allowed to take effect, the lower courts' decisions would upend existing caselaw and the FDA's long, well-established approval process for all pharmaceuticals, not just mifepristone. That would result in chaos and disruption to the healthcare system on a national scale.

"No prior decision has endorsed the lower courts' approach to review FDA's decisions regarding drug approvals and REMS [Risk Evaluation and Mitigation Strategies] which would deeply disrupt the pharmaceutical industry," Prelogar wrote, adding a quote from a pharmaceutical industry amicus brief submitted in opposition to Kacsmaryk's radical ruling --- a quote that can also be found in an open letter published last week that was signed by more than 500 pharmaceutical executives and researchers:

While it's always difficult to discern how SCOTUS will rule, the compelling nature of the Solicitor General's arguments; the need to preserve the status quo pending thoughtful judicial analysis; and even Justice Alito's responsible issuance of Friday's administrative stay, all seem to point, at least for now, in the right direction...

UPDATE, 4/19/23: Justice Alito issued an order extending the temporary administrative stay of the lower courts' mifepristone rulings to Friday, April 21.

UPDATE, 4/21/23: By way of a 7 - 2 Decision [PDF] (Justices Alito and Thomas dissenting), the U.S. Supreme granted a stay of both the 5th Circuit and District Court decisions to until the end of the appellate process, including a final disposition on a petition for a writ of certiorari before the Supreme Court. This means that the status quo in which either a physician or certified pharmacy will still be able to prescribe mifepristone without the necessity of an in-patient visit. Women will still be able to access the medication through the 70th day of pregnancy and still receive the medication via delivery services that includes tracking. It also means that women will still have access to generic mifepristone pursuant to a 2019 FDA approval.

In a Tweet, attorney Mark Joseph Stern observed:

As we previously reported, in two federal cases pending in North Carolina and West Virginia, plaintiffs have argued that a State bans on mifepristone violate the Supremacy and Commerce Clauses of the U.S. Constitution. If Danco and the FDA ultimately prevail on the merits in this case, those cases could then potentially establish a nationwide right to medication abortions.

                 

Article Categories: Rights And Freedoms, U.S. Constitution, Washington State, Health Care, U.S. Supreme Court, Donald Trump, Samuel Alito, FDA, Elizabeth Prelogar