The Biden administration and a company that manufactures the abortion pill on Friday both called on the U.S. Supreme Court to preserve access to mifepristone while a closely watched lawsuit works its way through the appeals process.
The U.S. solicitor general wrote in the Department of Justice appeal that allowing lower courts’ rulings to take effect would “create significant chaos for patients, prescribers, and the health care delivery system.”
The two separate emergency appeals ask the justices to place on hold the entirety of a federal district court’s ruling from one week ago that would have overturned the U.S. Food and Drug Administration’s 2000 approval of the abortion medication.
The federal government and Danco Laboratories appealed to the Supreme Court after the 5th Circuit Court of Appeals in New Orleans placed part of that district court ruling on hold late Wednesday night.
The three-judge appeals panel’s ruling would have kept mifepristone on the market during the appeals process, though they called for the prescribing and administration of the medication to revert to pre-2016 instructions.
Those changes would reduce when mifepristone can be taken from 10 weeks gestation to seven, require doctors to prescribe and administer the medication instead of health care providers with prescribing authority and require three in-person visits.
Prescribing mifepristone via telehealth and mailing it to patients would be barred under the 5th Circuit’s partial stay of the district court ruling. The dosage and timing of medication abortion, a two-drug regimen that includes misoprostol, would also change.
“The orders would ‘immediately’ render all extant doses of mifepristone misbranded because their labeling would be inconsistent with the operative conditions of approval,” Solicitor General Elizabeth Prelogar wrote in the federal government’s appeal. “The generic version of the drug would cease to be approved altogether.”
“FDA and mifepristone’s sponsor would have to adjust the drug’s labeling to account for the lower courts’ actions — a process that could take months,” Prelogar added.
Danco Laboratories, which manufactures the brand name version of mifepristone, wrote in a 47-page brief the 5th Circuit’s decision to push prescribing and administration of the medication back to the guidelines used before 2016 amounts to a ban.
Danco’s legal team also noted a conflicting ruling from the U.S. District Court for the Eastern District of Washington, which on April 7 ordered the FDA not to alter access to mifepristone in the 17 states and Washington, D.C. that filed suit in that court.
Judge Thomas Rice, issued his original order on Friday, April 7, just minutes after the Texas federal judge issued his order overturning the FDA’s approval of mifepristone.
Rice, in clarifying his ruling Thursday following a request from the federal government, reinforced that the FDA cannot alter access to mifepristone in those locations.
Rice wrote in a six-page clarification that “irrespective of the Northern District of Texas Court ruling or the Fifth Circuit’s anticipated ruling” the FDA was barred from “altering the status quo and rights as it relates to the availability of Mifepristone” under current prescribing and administration guidelines in those 17 states and Washington, D.C.
In the appeal filed to the Supreme Court on Friday, Danco Laboratories wrote that in the Dobbs v. Jackson Women’s Health Organization decision last summer, which overturned the constitutional right to an abortion that had stood for nearly 50 years, the justices “returned” decisions about abortion “to the people and their elected representatives.”
“If the Court denies a stay, it abandons that assurance,” Danco wrote. “Allowing the Fifth Circuit’s opinion to stand eviscerates the sovereign authority of States that wish to expand and protect access to medication abortion in their jurisdictions.”
Government asserts mifepristone safety
The federal government, in its appeal, argued in support of the FDA’s medical and scientific authority in approving pharmaceuticals as well as on the safety and efficacy of mifepristone.
The U.S. solicitor general wrote the 5th Circuit was “demonstrably wrong” when it wrote in its partial stay that FDA “failed to ‘examine the relevant data’” when it changed prescribing and administration guidelines in 2016.
“The court’s holding that the 2016 changes were arbitrary and capricious thus ultimately rests on its assertion that FDA failed to cite a study that evaluated the effects of those changes ‘as a whole,’” Prelogar wrote.
“In other words, the court appeared to hold that FDA cannot change a drug’s conditions for approval unless it can cite a single study that combines all of the relevant changes,” Prelogar added. “That holding contradicts settled principles of administrative law, the (Federal Food, Drug, and Cosmetic Act), and common sense. And it is factually incorrect in any event.”
The federal government’s appeal later notes that “As of June 2022, only 28 deaths had been reported among the more than 5 million women who have taken mifepristone, and some of them had obvious alternative causes — including homicide, drug overdose, and other factors entirely unrelated to mifepristone.”
“In addition, pregnancy itself entails a significantly higher risk of serious adverse events, including a death rate 14 times higher than that associated with legal abortion,” the solicitor general wrote.
ADF urges ‘accountability’
Alliance Defending Freedom, the legal organization that filed the original lawsuit on behalf of four anti-abortion medical organizations and four anti-abortion doctors, said in a statement Friday that the Supreme Court should leave the 5th Circuit’s partial stay in place.
“The 5th Circuit rightly required the agency to prioritize women’s health by restoring critical safeguards, and we’ll urge the Supreme Court to keep that accountability in place,” said Senior Counsel Erin Hawley.
Hawley, a key lawyer in the case, is the wife of U.S. Missouri Republican Sen. Josh Hawley, who sits on the Judiciary Committee, which oversees the confirmation process for U.S. Supreme Court justices.
Sen. Josh Hawley during his tenure in the Senate voted to confirm Amy Coney Barrett, but voted against the confirmation of Ketanji Brown Jackson.
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