A group of pharmaceutical companies and executives have filed a brief challenging a court decision that stripped the long-standing government approval of an abortion drug.
The brief filed on 12 April was joined by major firms including Gilead Sciences, Juvena Therapeutics and Pfizer, among others.
Dozens of individual doctors and health care providers signed the amicus brief, which argues that US District Judge Matthew Kacsmaryk’s decision that sided with anti-abortion activists against the Food and Drug Administration’s approval of mifepristone would imperil the companies.
“The district court’s decision is at odds with that longstanding statutory and regulatory framework,” the brief said. “The district court unreasonably found fault with FDA’s sound scientific judgments in order to stay approval of a drug that has been approved for nearly a quarter-century and used safely by millions of women.”
The brief also criticised the ruling for misapplying drug approval laws and substituting the judge’s personal conclusions “drawn from anecdotes and cherry-picked publications” for the FDA’s arduous approval process.
“Far from being limited to one drug, the logic of the district court’s order overturns the long-settled legal basis of FDA’s drug-approval process,” the briefing reads. “Unless stayed, the district court’s lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients’ access to critical medicines.”
The brief also said that the ruling would “chill” research into and undermine investments for crucial treatment.
In addition, it also argues that the FDA, not courts that lack expertise, should be in charge of drug approval. It also took issue with Judge Kacsmaryk’s faulting the FDA for not denying a new drug application for mifepristone for not including “adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.”
“However, the opinion identified no errors in FDA’s scientific judgment or calculations,” the briefing argued. “Instead, the court proffered its own, competing analysis, which lacked any evidence that could support the type of rigorous scientific decision-making with which FDA is tasked.”
The brief also said that the court’s reasoning would create more rigid standards for drug development.
“The district court’s approach would have ripple effects across FDA’s programs for drugs intended to treat serious and life-threatening diseases and conditions — programs that are essential to facilitating and expediting the development and review of critical medicines,” the briefing said.
The brief comes after a group of more than 400 executives with major drug manufacturers sounded a similar warning in a scathing letter denouncing Judge Kacsmaryk’s decision.
“The decision ignores decades of scientific evidence and legal precedent,” said the letter, which was signed by leaders at Pfizer and Biogen, among others.
“If courts can overturn drug approvals without regard for science or evidence,” the letter said, “or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”
Democrats have chastised Judge Kacsmaryk’s decision since he dropped it on Friday evening, saying it jeopardises access to abortion care even in states where abortion remains legal. The US Department of Justice appealed the decison and many have criticised Judge Kacsmaryk for using anti-abortion activist language like referring to abortion providers as “abortionists,” abortion patients as “post-abortive women” and a fetus as an “unborn human.”
Alex Woodward contributed reporting
