Pfizer’s CEO has signed an open letter calling for the reversal of a federal judge’s decision to suspend the Food and Drug Administration’s approval of the abortion pill mifepristone.
Albert Bourla was one of greater than 200 pharmaceutical company executives to sign the letter following a controversial ruling by U.S. Judge Matthew Kacsmaryk on Friday.
“We call for the reversal of this decision to disregard science and the appropriate reinstatement of the drug safety and efficacy mandate for everybody from the FDA, the agency entrusted with this in the first place,” the letter reads.
Management said Kacsmaryk’s decision “ignores many years of scientific evidence and legal precedent.” Additionally they expressed concern that the ruling would “set a precedent” for reducing the authority of the FDA to approve drugs, which might create uncertainty for the entire industry.
“If courts can overrule drug approvals regardless of the science or evidence or complexity required to completely confirm the safety and efficacy of recent drugs, any drug is in danger of having the same effect as mifepristone,” the directors wrote in the letter.
They added that regulatory uncertainty is probably going to cut back incentives to speculate in recent drugs, which might jeopardize “the innovations that characterize our industry.”
Pfizer is one of the first major drug corporations to publicly react to the ruling. Other directors who signed the letter include: Biogen President Alisha Alaimo and Cristal Downing, Merckchief communications and public affairs officer.
A letter is attached link to a Google form so other directors and employees can add their names.
Modern, Eli Lily AND Johnson & Johnson he didn’t immediately reply to requests for comment on the letter.
On Monday, the major pharmaceutical industry lobby, PhRMA, released a separate statement saying Kacsmaryk’s ruling undermines the regulatory process.
“The FDA is the gold standard for determining whether a drug is protected and effective in humans,” said Priscilla VanderVeer, PhRMA’s vp of public affairs. “While PhRMA and our members should not a party to this dispute, we’re focused on providing a policy environment that supports the agency’s ability to manage and provides access to FDA-approved drugs.”
Kacsmaryk sided with the anti-abortion group, arguing that the FDA rushed the approval process and violated federal standards. He suggested that the agency ignored the serious safety risks related to mifepristone because of “political pressure”.
“The court doesn’t disregard the FDA’s decision,” Kacsmaryk wrote in his decision. “But here the FDA agreed with its legitimate safety concerns – in violation of its statutory duty – based on clearly faulty reasoning and research that did not support its conclusions.”
In an open letter, management acknowledged that the FDA’s drug development and approval process shouldn’t be perfect. Nevertheless, they defended the agency’s longstanding determination that mifepristone was a protected and effective method of terminating early pregnancy.
The abortion pill “has been proven through many years of data to be safer than Tylenol, nearly all antibiotics and insulin,” the directors wrote in the letter.
The FDA declined to comment on the letter, referring CNBC to the agency statement on Saturday.
“[Mifepristone’s] the approval was based on the best available scientific knowledge and was made in accordance with the laws that govern our work,” reads the statement.
The FDA approved mifepristone in 2000. Medical abortion has since change into the most available and preferred method of termination of pregnancy in the United States, considering over half of all abortions nationwide.
Mifepristone might be available shortly as Kacsmaryk delayed the order by a week to provide the Biden administration time to appeal.
Kacsmaryk’s decision contradicts the ruling of a federal judge in the state of Washington. Lower than an hour after the ruling in Texas, a Washington state judge issued a preliminary injunction that might protect access to mifepristone in 17 states and Washington, which filed the lawsuit, arguing that there are too many laws on the drug.
Dueling orders issued by two federal judges create a complicated legal dispute that might potentially escalate to the Supreme Court.
— Meg Tirrell and Spencer Kimball of CNBC contributed to this report.