Pfizer CEO indicators letter in assist of FDA
Pfizer’s CEO signed an open letter calling for the overturning of a federal judge’s decision to stay the Food and Drug Administration’s approval of the abortion pill mifepristone.
Albert Bourla was among more than 200 drug company executives who signed the letter following U.S. Judge Matthew Kacsmaryk’s controversial ruling on Friday.
“We call for the overturning of this science disregard decision and the appropriate restoration of the drug safety and efficacy mandate to all with the FDA, the agency responsible for doing so,” the letter reads.
Executives said Kacsmaryk’s decision “ignored decades of scientific evidence and legal precedent.” They also raised concerns that the ruling would “set a precedent” to reduce the FDA’s authority over drug approvals, creating uncertainty for the entire industry.
“If courts can reverse drug approvals without consideration of science or evidence or the complexity required to fully review the safety and efficacy of new drugs, each drug faces the same risk as mifepristone,” the executives wrote in the letter .
They added that regulatory uncertainty is likely to reduce incentives to invest in new drugs, which would threaten the “innovation that characterizes our industry.”
Pfizer is one of the first major pharmaceutical companies to publicly respond to the ruling. Among the other executives who signed the letter are biogenic President Alisha Alaimo and Cristal Downing, noticeis Chief Communications and Public Affairs Officer.
The letter included a link to a Google form for other executives and employees to add their names.
Modern, Eli Lilli And Johnson&Johnson did not immediately respond to requests for comment on the letter.
On Monday, the pharmaceutical industry’s primary lobbying arm, PhRMA, issued a separate statement saying Kacsmaryk’s ruling undermines the regulatory process.
“The FDA is the gold standard for determining whether a drug is safe and effective,” said Priscilla VanderVeer, vice president of public affairs at PhRMA. “Although PhRMA and our members are not parties to this litigation, our focus is to ensure a policy environment that supports the agency’s ability to regulate and provide access to FDA-approved drugs.”
Kacsmaryk sided with an anti-abortion group, arguing that the FDA rushed its approval process and violated federal standards. He suggested the agency ignored mifepristone’s serious safety risks due to “political pressure”.
“The court does not take FDA decision-making lightly,” Kacsmaryk wrote in his ruling. “But here the FDA has acknowledged its legitimate safety concerns – in breach of its legal duty – on the basis of patently unsound arguments and studies that did not support its conclusions.”
In the open letter, executives acknowledged that the FDA’s drug development and approval process is not perfect. However, they defended the agency’s longstanding finding that mifepristone is a safe and effective method of terminating an early pregnancy.
The abortion pill “has been proven by decades of data to be safer than Tylenol, almost all antibiotics and insulin,” the executives wrote in the letter.
The FDA declined to comment on the letter, referring CNBC to the agency’s statement on Saturday.
“[Mifepristone’s] The approval was based on the best available science and in accordance with the laws that govern our work,” the statement said.
The FDA approved mifepristone in 2000. Since then, medical abortion has become the most accessible and preferred method of terminating pregnancy in the United States, accounting for more than half of all abortions nationwide.
Mifepristone will be available at short notice because Kacsmaryk delayed his order by a week to give the Biden administration time to appeal.
Kacsmaryk’s decision contradicts a ruling by a Washington state judge. Less than an hour after the Texas ruling, the Washington state judge issued an injunction that could protect access to mifepristone in the 17 states and Washington, DC, leading to a lawsuit arguing that it was too there are many prescriptions for the drug.
Two federal judges’ dueling orders are creating a complicated legal standoff that could potentially escalate all the way to the Supreme Court.
– CNBC’s Meg Tirrell and Spencer Kimball contributed to this report.