April 11, 2023: Pfizer’s CEO is signing on to a start letter calling for reversing a federal judge’s decision suspending the Food and Drug Administration’s approval of the abortion tablet mifepristone.
Albert Bourla was from the over 200 pharmaceutical company executives who signed the letter following U.S. Judge Matthew Kacsmaryk’s controversial ruling starting on Friday.
“We call for the reversal of this to disregard science and the near restitution of the mandate for the safety of medicines for every with the FDA, the agency entrusted to do so in the initial place,” the letter stated.
The executives supported the FDA’s authority to regulate drugs and said Kacsmaryk’s conclusion “ignores decades of scientific evidence and legal precedent.” They are also concerned that the ruling will “set a precedent” for diminishing the FDA’s authority regarding drug approvals, creating uncertainty for the entire industry.
“If courts can start drug approvals regarding for science or evidence, or for the difficulties required to vet being safe of new drugs fully, any medicine is at the problems for the same outcome as mifepristone,” the executives stated in the letter.
They further stated that regulatory uncertainty will likely decrease incentives for investing in recent drugs, which would endanger the “innovation that states our industry.”
Pfizer is one of the initial major pharmaceutical companies to react publicly to the ruling. Among the different executives who signed the letter is Biogen President Alisha Alaimo.
Kacsmaryk sided with an anti-abortion group, fighting the FDA rushed its approval and violated federal standards. He suggested the agency ignored mifepristone’s safety risks because of “political pressure.”
“The Court does not second-guess FDA’s to conclude lightly,” Kacsmaryk wrote in his decision. “But right now, FDA acquiesced on its safety concerns violating of its statutory duty based on plainly unsound the conditions and studies that did not support its conclusions.”
The abortion pill “has been proven by much of data to be more unassailable than Tylenol, every antibiotic and insulin,” the executives stated in the letter.
The FDA approved mifepristone in 2000. Medication abortion has become the highest accessible and preferred method for changing a pregnancy in the U.S. After that, accounting for more than half of all abortions nationwide.