WASHINGTON (CN) — The Supreme Court was asked on Friday to intervene in a high-stakes battle over the Food and Drug Administration’s decades old approval of the abortion pill mifepristone.
Danco Laboratories — the maker of mifepristone — as well as the Department of Justice filed dueling emergency appeals to the justices this morning, asking them to immediately pause a lower court ruling that would take the abortion drug off shelves nationwide. The government requested an immediate administrative stay against the injunction on mifepristone that will otherwise take effect at 1 a.m. on Saturday.
“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,” U.S. Solicitor General Elizabeth Prelogar wrote.
The Fifth Circuit granted a partial stay late Wednesday that changes how the popular abortion drug is administered. Not going as far as the district court, which ruled last week to take mifepristone off the market, the panel upheld regulations that would change how the drug is prescribed and dispensed.
Prelogar said the lower court rulings would leave all mifepristone currently on the market misbranded because of the altered approval status. She notes this would include the generic version of the drug — which would cease to be approved altogether. The process of relabeling could take months and puts the FDA in an impossible position, according to the government.
“The Fifth Circuit’s unprecedented order has created regulatory chaos across the country,” Jessica Ellsworth, an attorney with Hogan Lovells representing Danco, wrote in the application. “The direct consequence of the Fifth Circuit’s ruling is that FDA must effectuate a series of extensive approvals to implement the Fifth Circuit’s rollback. Without those approvals, Danco cannot legally market and distribute mifepristone.”
U.S. District Judge Matthew Kacsmaryk issued a national injunction last week on mifepristone’s FDA approval, arguing the agency had abandoned its safety proposals when approving the drug. One of two medications used in pill abortions, mifepristone has been used across the nation by over 5.6 million women for more than two decades. Kacsmaryk also embraced arguments that mifepristone was unsafe, even though the government provided evidence to the contrary.
The Alliance for Hippocratic Medicine led the charge against mifepristone’s approval. According to the group, someone who took mifepristone could have a very rare reaction to the drug and land in the hospital. A doctor associated with the group could then have the potential to treat that patient and not be available to treat other patients who hadn’t taken mifepristone.
Offering a partial stay, the Fifth Circuit stopped mifepristone from being taken off the shelves nationwide. The panel reasoned that the medical group’s challenge to mifepristone’s 2000 approval was barred by the statute of limitations. However, mifepristone had subsequent approvals that changed how it was administered — from up to seven weeks to 10 weeks — and how it was dispensed — requiring a series of doctors appointments to telehealth and through the mail. The Fifth Circuit paused these later approvals expanding mifepristone’s use while the full appeal proceeds.
The panel found the FDA did not show the agency would be harmed by the district court ruling because it focused on harm to women instead of the agency.
“FDA’s assertion that the district court’s injunction will harm pregnant women or other members of the public does not speak to the irreparable injury factor (although it may speak to other factors), because those persons are not stay applicants in this case,” the panel wrote (parentheses and italics in original). “Since FDA does not articulate any irreparable harm that FDA will suffer absent a stay, it makes no showing on this ‘critical’ prong.”
The government said it has spent the last week attempting to figure out how to legally comply with Kacsmaryk's ruling. Then the FDA was faced with a conflicting ruling out of Washington state.
"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," Prelogar wrote. "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."
Claiming this is the first time a court has done anything like this, the Biden administration urged the justices to step in.
"This Court should put a stop to that untenable situation by staying the district court’s order in full," Prelogar wrote.
Kacsmaryk’s ruling was condemned by drug company leaders who worried it would upend the approval process for critical medications. Mifepristone has not only been on the market for two decades, but the drug has been proven to be safer than common medications like penicillin and the erectile-dysfunction drug Viagra.
The Biden administration noted mifepristone’s safety record in it’s appeal to the Fifth Circuit.
“When mifepristone is used as FDA directs, serious adverse events are exceedingly rare, just as they are for many common drugs like ibuprofen,” Brian Boynton, principal deputy assistant attorney general, wrote in the government’s stay application.
Calling the district court ruling an extraordinary, unprecedented and ultimately delayed attempt to remove mifepristone from the market, the government said the appeals court had reason to grant a stay because the medical groups lacked standing to bring the suit. None of the doctors involved have ever administered mifepristone, but instead claim they could have to treat patients in the future who have.
A doctor-led nonprofit advocating for reproductive health said the case will have far-reaching impacts on reproductive health, medical ethics and patient autonomy.
“The District Court agreed with Plaintiffs-Appellees’ erroneous assertion that its decision would increase and promote patient well-being and healthy outcomes,” the group said in an amicus brief. “As physicians and experts in reproductive health, PRH knows this is false. Eliminating access to mifepristone will hurt patients by eliminating their ability to choose treatment that is medically sound, and will jeopardize patient health.”
More than 200 members of Congress signed on to an amicus brief that claims revoking mifepristone’s approval would violate the Constitution’s separation of powers. Lawmakers said upending the congressionally mandated drug approval process poses serious health risks.
“Congress designated the U.S. Food and Drug Administration (“FDA”) as the expert federal agency with authority to review and approve drug applications, including subsequent changes to those applications,” the lawmakers wrote in their brief. “While Congress permitted some judicial review of FDA’s approval decisions, it did not invite federal courts to substitute their judgment for the expert conclusions of FDA’s scientists.”
The Alliance for Freedom, which is representing the doctors, did not respond to requests for comment on the applications.Follow @KelseyReichmann
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