Pfizer‘s CEO signed on to an industry letter in support of the Food and Drug Administration’s authority to regulate drugs after a federal judge in Texas suspended the agency’s approval of the abortion pill mifepristone.
Albert Bourla was among the more than 200 pharmaceutical company executives who signed the letter after U.S. Judge Matthew Kacsmaryk’s controversial ruling on Friday.
The executives said the decision “ignores decades of scientific evidence and legal precedent.” They also raised concerns that the ruling will “set a precedent” for diminishing the FDA’s authority over drug approvals, which would create uncertainty for the entire industry.
“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 executives said in the letter.
Kacsmaryk sided with an antiabortion group, arguing that the FDA rushed its approval process and violated federal standards.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in his decision. “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.”
Pfizer is the first major pharmaceutical company to publicly react to the ruling. Moderna and Johnson & Johnson did not immediately respond to a request for comment.
— CNBC’s Meg Tirrell and Spencer Kimball contributed to this report.