500 pharma and biotech CEOs call for reversal of abortion pill ban
Pfizer’s CEO was the first major pharmaceutical company leader to add his name to the open letter, written after a Texas federal judge banned the use of the FDA-approved abortion pill mifepristone.
A U.S. judge on Friday suspended the U.S. Food and Drug Administration’s two-decade-old approval of the drug, effectively banning sales while a case brought by antiabortion groups before him continues in the Northern District of Texas. The ruling by Judge Matthew Kacsmaryk undermines the FDA’s authority, the letter’s authors wrote, adding that it ignores decades of scientific evidence and legal precedent.
“We call for the reversal of this decision to disregard science and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place,” the letter said.
Pfizer CEO Albert Bourla was the first leader of a major pharmaceutical company to add his name to the letter, which was written by Shehnaaz Suliman, CEO of ReCode Therapeutics; Amanda Banks, cofounder of Blackfynn; and Jeremy Levin, CEO of Ovid Therapeutics.
“You have the real potential of having medicines not being developed because it’s far too expensive, or medicines that are currently approved being withdrawn because they are political,” Levin said.
The executives acknowledged that the FDA’s drug development and approval process is not perfect. But they defended the agency’s longstanding determination that mifepristone is a safe and effective method to terminate an early pregnancy. The abortion pill “has been proven by decades of data to be safer than Tylenol, nearly all antibiotics and insulin,” the executives wrote in the letter.
In addition to Bourla, the letter was signed by representatives for Merck, Novartis and Biogen, as well as industry nonprofit groups like the Center for Medicine in the Public Interest. Industry giants Merck, Moderna, Eli Lilly and Johnson & Johnson did not immediately respond to media requests for comments.
Related: Walgreens will not dispense abortion pills in 20 states that threatened legal action
The decision puts the entire industry at risk, the letter says, and sets a precedent for undermining the agency’s authority to approve drugs, adding regulatory uncertainty that they warned would disincentivize investment in new treatments. “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 authors wrote.
Although the industry association PhRMA did not comment directly on the abortion pill case, a spokesperson did support the FDA approval process.
“The FDA is the gold standard for determining whether a medicine is safe and effective for people to use,” said Priscilla VanderVeer, the group’s vice president of public affairs. “While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to FDA-approved medicines.”
The full text of the letter and list of signers is available at DocSend,