(WASHINGTON) — The Justice Department on Friday asked the U.S. Supreme Court for an emergency stay of an appeals court ruling that would sharply restrict access to the widely-used abortion medication mifepristone.
The restrictions were set to take effect early Saturday morning.
On behalf of the Food and Drug Administration, the DOJ has asked the court to impose an immediate administrative stay of the 5th Circuit’s abortion pill decision — to preserve the status quo while the justices consider the application — but to ultimately stay the ruling pending appeal.
“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,” the DOJ stated.
The government says the ruling creates a “host of unprecedented issues” that put the FDA in an “impossible position,” particularly in light of the dueling order out of Washington state.
“Regulated entities are trying to discern their legal duties and urgently demanding guidance. FDA has spent the last week first grappling with the implications of the district court’s order, then racing to untangle the different and enormously more complicated issues raised by the Fifth Circuit’s decision. And in the meantime, another district court has enjoined FDA from doing anything to change the conditions on the distribution of mifepristone in 17 States and the District of Columbia — which means that FDA risks contempt if it takes action to permit the marketing of mifepristone in a manner consistent with the Fifth Circuit’s order. This Court should put a stop to that untenable situation by staying the district court’s order in full,” the Justice Department’s application said.
The administration told the high court that a decision by a district court federal judge in Texas is “the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety — much less done so after those conditions have been in effect for years.”
A few minutes earlier, Danco Labs, maker of the abortion pill mifepristone, also filed an emergency application with the court seeking a full stay of the Texas judge’s order pending appeal or asks the justices to take up the case immediately on the merits and decide it this spring.
Danco cites the conflicting ruling from the Eastern District of Washington as the primary basis for urging the court to get involved now.
The company cites “regulatory chaos” that would ensue if those old FDA restrictions snap back at midnight and an “untenable limbo for Danco, for providers, for women and for health care systems all trying to navigate these uncharted waters.”
Notably, both the FDA and Danco warn that if the 5th Circuit’s decision stands — reverting to circa-2000 restrictions of the abortion pill — all existing doses of mifepristone would be “misbranded” because their labeling would no longer comply with the approval standard.
In turn, they suggest, those doses could not be properly sold or distributed under regulations. Adjusting the drug’s labeling “could take months” they say.
The government also points out that such a scenario would invalidate all generic versions of the drug, since those were approved for use subsequent to the year 2000.
And, they warn of danger to women …. forcing the government to “reinstate a now-obsolete and unfamiliar dosing regimen [from 2000] that includes higher doses of mifepristone than what we now know are needed for the intended use,” which could harm patients.
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