". . . and having done all . . . stand firm." Eph. 6:13


After Supreme Court’s Temporary Abortion Pill Order, Pro-Lifers Remain Hopeful

April 24, 2023

The Supreme Court on Friday temporarily restored new FDA rules permitting the widespread distribution of the chemical abortion drug, mifepristone. The brief order, from which Justices Clarence Thomas and Samuel Alito dissented, granted without comment two “applications for stays” brought by the Food and Drug Administration (FDA) and Danco Laboratories, LLC., which manufactures abortion pills.

On April 7, a federal judge for the Northern District of Texas struck down FDA approval of mifepristone, finding the approval process was politicized and bypassed safety regulations, effectively halting the distribution of the drug. On April 12, the Court of Appeals for the Fifth Circuit narrowed the injunction to prevent its distribution through the mail or use after seven weeks’ gestation, effectively reverting to the rules that governed the pill in 2016. In response to the Fifth Circuit’s decision, the FDA and Danco Laboratories applied to the Supreme Court to “stay” (pause) the injunction, and the Supreme Court has now granted those requests.

The Supreme Court’s latest order is merely temporary. The one-paragraph order stays the district court’s injunction:

“[P]ending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari, if such a writ is timely sought. Should certiorari be denied, this stay shall terminate automatically. In the event certiorari is granted, the stay shall terminate upon the sending down of the judgment of this Court.”

Justice Alito noted that the appeal was “on a fast track” before the Fifth Circuit with “oral argument scheduled to take place in 26 days,” on May 17.

However, Alito saw no justification for the stay, which he argued “would not remove mifepristone from the market. It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations.” The Supreme Court’s decision “would not express any view on the merits of the question whether the FDA acted lawfully in any of its actions regarding mifepristone,” he continued. “Rather, it would simply refuse to take a step that has not been shown as necessary to avoid the threat of any real harm during the presumably short period at issue.”

Alito argued that “the applicants are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim.”

The FDA had claimed that “regulatory ‘chaos’ would occur,” citing a decision in the Eastern District of Washington. There, a judge had responded within hours to the Northern District of Texas decision with a virtually opposite finding and had “enjoined the FDA from altering its current practice regarding mifepristone,” as Alito described. But Alito noted that “the FDA had never hinted it was contemplating” such an action and “did not appeal that appealable order,” even opposing the request of seven states that sought to intervene. This behavior led Alito to conclude that the FDA “has not acted equitably” and “has engaged in what has become the practice of ‘leverag[ing]’ district court injunctions ‘as a basis’ for implementing a desired policy while evading both necessary agency procedures and judicial review.”

Danco had claimed that it “could not continue to market mifepristone because the drug would be mislabeled.” But Alito argued that would only be a problem if “the FDA elected to use its enforcement discretion to stop Danco,” and there wasn’t “any reason to believe the FDA would make that choice.” Far from it, “the FDA has previously invoked enforcement discretion to permit the distribution of mifepristone in a way that the regulations then in force prohibited, and here, the Government has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases.”

The group challenging the FDA rules, the Alliance for Hippocratic Medicine, is represented by the Alliance Defending Freedom (ADF), which did not express alarm over the Supreme Court’s order. “As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit,” responded ADF attorney Erik Baptist. “The FDA must answer for the damage it has caused to the health of countless women and girls and the rule of law by failing to study how dangerous the chemical abortion drug regimen is and unlawfully removing every meaningful safeguard, even allowing for mail-order abortions.”

“The court essentially hit the pause button on our victories from the lower courts … because what we are asking is relatively ambitious: … to take this drug off the marketplace and restore previous safeguards,” Baptist said on “Washington Watch” Monday. “This is going to get fully briefed up in the next few weeks. And then they’re going to hear our case on the merits. Prior appeals were done on the emergency motions by the government. So this is the first time we’re going to actually have the merits being heard by both the Fifth Circuit and maybe one day the Supreme Court.”

Due to the expedited nature of the case, Baptist expects that the Fifth Circuit could issue a ruling on the May 17 arguments by this summer. “If we prevail at the Fifth Circuit, the Biden administration and the FDA, they’re going to go right back to the Supreme Court and ask for relief,” he said.

Baptist believes his clients are likely to prevail at the Fifth Circuit because “from day one, the FDA has violated federal laws and even the agency’s own regulations.”

“From the beginning, the FDA considered pregnancy an illness and argued that chemical abortion drugs provide a meaningful therapeutic benefit. We know that’s not true, but that was the only way they could justify their approval in 2000 to use their fast-track approval authority,” Baptist explained. Additionally, “When [Congress] delegated its authority to the FDA to be the nation’s drug gatekeeper, it gave specific instructions to the FDA … to study the safety and effectiveness of a drug under the approved conditions of use as directed by the label. That is something the FDA has not done for the last two decades and change.”

But Baptist said the Biden administration went further and “took the health care provider out of the equation and said, ‘You don’t need to meet with that doctor to be screened for these type of complications or gestational age. You can just do this by phone, by computer, and obtain these drugs.’ That’s reckless, dangerous, and frankly illegal.”

“Right now, over 50% of abortions are committed by chemical means. And what we’ve seen correspond with that is the escalation by 500% of emergency room visits by women after abortions, in particular because of the chemical abortion drug,” said Baptist. “So, we have asked the court to hold the FDA accountable for failing to follow the law.”

Joshua Arnold is a staff writer at The Washington Stand.