A federal judge’s decision to revoke the approval of an abortion pill rippled across the biotechnology industry over the weekend, as industry leaders warned the ruling could threaten the Food and Drug Administration’s authority to regulate medicines.
The decision, issued by U.S. District Court Judge Matthew Kacsmaryk, invalidates the approval of mifepristone, a pill involved in more than half of the abortions in the U.S. It marked the first time in modern history the judiciary has overturned an approval issued by the FDA, whose role is to assess the safety and effectiveness of new drugs. It also adds to a growing politicization of the “entire FDA approval process,” said Allison Whelan, an assistant law professor at Georgia State University College of Law.
“What we may see is a domino effect, with ramifications for drugs beyond mifepristone, particularly any that are politically, ethically or socially controversial,” she said in an interview.
The FDA has appealed the decision, which is now likely to work its way to the Supreme Court. But in the meantime, industry leaders and lobbying groups rallied behind the agency, arguing that Kacsmaryk’s ruling, if it stands, could provide a blueprint for reversing more drug clearances.
“Judicial activism will not stop here,” read a letter signed by more than 300 biotech investors and executives over the weekend. “If courts can overturn drug approvals without regard for science or evidence, 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.”
Rachel King, the interim president and CEO of the Biotechnology Innovation Organization, added in a separate statement that the decision sets “a dangerous precedent for undermining the FDA” and creates “regulatory uncertainty that will impede the development of important new treatments and therapies.”
Kacsmaryk’s decision was the result of a suit filed by the Alliance for Hippocratic Medicine on behalf of conservative anti-abortion groups and doctors. The groups sued the FDA and the U.S. Department of Health and Human Services, arguing that the regulator misapplied its process for granting accelerated approval to mifepristone in 2000 and that the medicine should be removed from the market.
Those assertions were challenged by FDA scholars as well as agency lawyers, who argued the regulator evaluated “extensive scientific data” over its two decades on the market. The Government Accountability Office also found no impropriety in the approval process in a report published more than a decade ago. The medicine is considered highly safe and effective.
Nonetheless, Kacsmaryk on Friday ruled in favor of the plaintiffs, writing the agency “acquiesced on its legitimate safety concerns” and approved the drug “based on plainly unsound reasoning and studies that did not support its conclusions.” Kacsmaryk added that the FDA bowed to “significant political pressure” in clearing mifepristone.
The FDA defended its review of mifepristone in a statement on Saturday, noting that its approval was “based on the best available science and done in accordance with the laws that govern our work.”
The agency “stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy,” the regulator said.
Others have rushed to the agency’s defense as well, wary of the impact the decision could have on drug regulation. Jack Resneck, the president of the American Medical Association, said Kacsmaryk’s opinion “flies in the face of science and evidence.” President Joe Biden added that the court “substituted its judgment for [the] FDA” and that, if the ruling were to stand, “there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
The effects could be acutely felt by biotech companies. The sector relies on the regulator’s expertise to evaluate new medicines, as well as the processes in place for bringing drugs to market or withdrawing an approval, if warranted. Kacsmaryk’s decision, if upheld, would diminish the agency’s authority and create “uncertainty for the entire biopharma industry,” investors and executives wrote in their letter.
Whelan, for instance, noted that clearances of vaccines, hormone treatments for transgender individuals and gene therapies, among other medicines, could be challenged in the future.
“If more cases like this follow, access to many drugs, some of which are life-saving, could be endangered,” she said.