More than 300 current and former biotech and pharmaceutical executives have signed an open letter criticizing a federal Texas judge over his recent decision to suspend FDA approval of the abortion pill mifepristone.
“We cannot stay quiet. We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place,” the executives wrote in the letter.
Letter
The letter criticized U.S. District Judge Matthew Kacsmaryk, a Trump appointee in Amarillo, Texas. On April 7, the judge signed an injunction directing the FDA to stay mifepristone’s approval.“The decision ignores decades of scientific evidence and legal precedent,” the letter states. “Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.”
The letter adds that, “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.”
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions.
“There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion—which was the ‘whole idea of mifepristone.'”
Levin told Reuters that the ruling is “a nightmare scenario for the industry.”
“You have the real potential of having medicines not being developed because it’s far too expensive, or medicines that are currently approved being withdrawn because they are political,” Levin said.
Congress
Kacsmaryk’s ruling has drawn a mixed response from lawmakers.“Study after study has found mifepristone to be an exceedingly safe and effective way to end a pregnancy,” Lee wrote. “As Co-Chair of the Pro-Choice Caucus, I am working closely with our partners to respond to this egregious ruling and preserve access to mifepristone nationwide.”
“I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that,” Wyden wrote.
“When this drug was approved over 20 years ago, it relied on flawed and irrelevant studies and failed to adequately study the dangers this drug posed for adolescent girls,” Aderholt wrote. “As long as chemical abortion drugs are available, the lives of women and the unborn are at stake.”
“The Biden administration continues to say that easy abortions are crucial to women’s healthcare, but the FDA pushed abortion pills to market which have killed mothers and their children,” Lamborn added.
