Following similar campaigns mounted by industry players and biopharma trade groups, the United States' Solicitor General has joined a chorus of voices calling on the Supreme Court to overturn an appeals court’s August ruling surrounding the abortion pill mifepristone.
If the lower court’s decision is allowed to stand, it could upend the regulatory process in the U.S. and pave the way for lawsuits questioning virtually any approved drug on the market, organizations like the trade group Pharmaceutical Researchers and Manufacturers of America (PhRMA) have argued in recent months.
Now, writing for the U.S. Food and Drug Administration, Elizabeth Prelogar is pressing SCOTUS to rethink the Fifth Circuit’s “unprecedented decision,” the Solicitor General said in a reply brief published late this month.
Like PhRMA and the companies rallying behind mifepristone, Prelogar warned that the appeals court's verdict threatens the FDA’s decision-making power. Such an approach would “call into question countless other drug approvals," Prolegar wrote.
Over the summer, the U.S. Court of Appeals for the Fifth Circuit moved to revoke the FDA’s approval of mifepristone for distribution by mail. It also shrank the timeframe the drug can be used during pregnancy—from 10 weeks to 7 weeks.
At the time, the panel of judges agreed with the plaintiffs, the Alliance for Hippocratic Medicine, that the FDA’s mifepristone approval process was flawed and exceeded its regulatory authority.
The Alliance has alleged the FDA rushed its 2000 approval of the drug, justifying its decision by labeling pregnancy as an illness.
Prelogar countered in her reply brief that the Fifth Circuit leveraged a “novel and unworkable” legal framework to review the FDA’s drug approvals. She cited prior amicus briefs from the pharmaceutical industry underscoring the extent to which the lower court “strayed from settled principles of standing and administrative review."
The industry has been pushing back hard against the Fifth Circuit’s decision. Late this summer, mifepristone-maker Danco Laboratories called on the High Court to overturn the appeals court’s verdict, arguing that “risks and confusion” stemming from the Fifth Circuit’s decision would unfairly fall upon women, teenage girls and the public health system.
“Denying review of the Fifth Circuit’s opinion would eviscerate the sovereign authority of states that have chosen to expand and protect access to medication abortion in their jurisdictions,” Danco’s legal team argued at the time.
In October, PhRMA and a plethora of industry players lodged amicus briefs pressing the Supreme Court to reverse the Fifth Circuit’s determination. If the ruling were allowed to stand, FDA approvals would become “mere precursors to litigation,” PhRMA said.
Mifepristone remains unrestricted until the Supreme Court decides whether or not to review the case.