In an open letter published Monday, more than 480 biopharma industry leaders expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone.
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Update (April 12) All New Information:
On Wednesday, the U.S. 5th Circuit Court of Appeals partly blocked Judge Matthew Kacsmaryk’s ruling overturning the FDA’s approval of the abortion pill mifepristone.
The challenge to mifepristone’s 2000 approval appeared to be blocked by the statute of limitations, according to Bloomberg. However, the panel—which was divided—allowed restrictions to the delivery of the pill by mail and without follow-up doctor’s visits.
Appeals court Judge Catharina Haynes said she would have temporarily halted the ruling, while Judges Kurt Engelhardt and Andrew Oldham declined a stay related to the FDA’s more recent changes, according to Bloomberg.
On Tuesday, a group of more than 150 biopharma leaders signed an amicus brief to the U.S. 5th Circuit Court of Appeals, arguing that the district court’s ruling “radically alters” the FDA’s New Drug Application process.
In an open letter published Monday, more than 480 biopharma industry leaders, including Pfizer CEO Albert Bourla and former Alnylam founding CEO John Maraganore, expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone.
In his 67-page ruling released Friday, District Judge Matthew Kacsmaryk issued a preliminary injunction that would block sales of mifepristone. At the same time, the court continues to hear a case filed by anti-abortion groups, convened under the recently formed Alliance for Hippocratic Medicine, against the FDA.
The plaintiffs first filed their motion in November 2022, seeking to “withdraw or suspend” the FDA’s approval of mifepristone and have the drug removed from the Agency’s list of approved drugs.
In their lawsuit, the Alliance, along with pro-life medical associations and individual petitioners, argued that the FDA “failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States.”
The plaintiffs also alleged that the regulator “never studied the safety of the drugs under the labeled conditions of use.”
While Kacsmaryk has yet to reach his final verdict on the case, he noted in his Friday ruling that the plaintiffs have a strong case and a “substantial likelihood of prevailing on the merits” of their motion.
“[The] 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,” Kacsmaryk wrote in his decision.
Kacsmaryk’s order will be stayed for seven days from posting to give the federal government time to file for emergency relief from the Court of Appeals.
Biopharma Responds
In the open letter, industry leaders called for the reversal of Kacsmaryk’s decision, saying that it fundamentally undermined the FDA’s authority, granted by Congress, to approve and regulate medicines.
Calling his ruling an “act of judicial interference,” the letter said that Kacsmaryk ignored the depth of scientific evidence backing mifepristone in his decision. Industry leaders also warned that Kacsmaryk’s decision set a legal precedent for biopharma and could open up other medicines for similar legal, politically-motivated challenges “without regard for science or evidence.”
The ruling could likely erode the FDA’s authority over the drug approval process, the open letter argued, and could be used as a basis to target other approved medicines.
Kacsmaryk’s preliminary injunction adds another layer of uncertainty to the already-risky process of discovering and developing new drugs. Aside from working to satisfy the FDA’s regulatory rigor, the authors wrote that the decision “creates uncertainty for the entire biopharma industry.”
Mifepristone is an oral drug designed to block progesterone, an important hormone for pregnancy. The drug was approved in 2000 to terminate early pregnancy through 70 days of gestation and is usually given together with misoprostol.
The progesterone blocker has been shown by decades of data “to be safer than Tylenol, nearly all antibiotics and insulin,” the open letter read.
Beyond biopharma, the White House has also sided with the FDA. Pres. Joe Biden and Vice Pres. Kamala Harris both issued statements promising to fight Kacsmaryk’s ruling.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com
