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Supreme Court grants DOJ a stay in abortion pill controversy

by | Apr 17, 2023

By Dave Andrusko

On Friday, Supreme Court Justice Samuel Alito granted a request from the Justice Department for an administrative stay, which preserves the status quo as the court decides what to do with a trial judge decision that halted the FDA’s 2000 approval of mifepristone as subsequently modified by a panel of the 5th U.S. Court of Appeals.

Justice Alito’s hold will stay in place until 11:59 p.m. Wednesday. He gave the Alliance for Hippocratic Medicine, which brought the challenge to the FDA’s approval of the drug, until noon Tuesday to respond.

“A lawyer for the anti-abortion doctors and medical organizations suing over mifepristone said the court’s action Friday was ‘standard operating procedure’ and urged the justices to allow the appeals court-ordered changes to take effect by the middle of next week,” according to Melissa Quinn of CBS News.

“Before arriving at the Supreme Court, the Justice Department swiftly appealed the lower court’s decision to the 5th Circuit and asked it to halt U.S. District Judge Matthew Kacsmaryk’s decision,” Quinn continued. “Late Wednesday, the appeals court paused the part of the decision that halted the FDA’s approval of the mifepristone, but it left in place remaining portions of the order that blocked changes made by the FDA beginning in 2016, tightening rules surrounding the most common method of terminating an early pregnancy.” Specifically, the changes, which threaten women’s health, were made by the FDA in 2016, 2021, and 2023.

The 5th Circuit decision left the original requirements that the drug be used only up to 7 weeks of pregnancy, three physician visits, removed the ability for the drug to be mailed or dispensed by pharmacies, prevented non-physicians from administering the drug and reinstates the reporting requirements for non-fatal adverse events.

However the 5th Circuit panel refused—for now—to undo the FDA’s original approval of mifepristone.

Solicitor General Elizabeth B. Prelogar told the court in the government’s filing, “If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority.”

According to Quinn, the decision by the Biden administration “to seek emergency relief from the Supreme Court was not unexpected — it said in filings to the 5th Circuit that it would turn to the high court if necessary — and is the latest move in its swift legal response to the decision from Kacsmaryk.”

“Medication abortions” [chemical abortions] account for more than half of all abortions in the U.S. Mifepristone is the first of two drugs—the second is misoprostol—used to abort a baby.

The Biden administration and the drug’s maker, Danco Laboratories, “now want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues,” the Associated Press [https://www.inquirer.com/health/supreme-court-abortion-pill-federal-rules-20230414.html]reported. “As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year.”

Meanwhile, adding another complicating factor, Judge Thomas O. Rice of Washington state clarified his ruling that compels the FDA not to do anything that might affect the availability of mifepristone in the 17 states with Democrat attorneys general who have sued. They argued that too many regulations already exist on the drug.

Judge Rice “said his decision, maintaining full unencumbered access to the drug, remains in effect ‘irrespective of the Northern District of Texas Court’s ruling [Judge Kacsmaryk] or the Fifth Circuit’s anticipated ruling,’” according to Fox News. “That includes access to the drug by mail” [https://www.msn.com/en-us/news/us/doj-to-appeal-abortion-pill-case-to-supreme-court/ar-AA19OXYk]. 

On April 5, National Right to Life released a white paper about the myths involving the Food and Drug Administration’s (FDA) approval and management of mifepristone (generic for Mifeprex),  accurately anticipating and answering many of the issues that have been raised in coverage of the case.

Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone) can be accessed here.

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