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 wrote in the letter.
They added that regulatory uncertainty will likely reduce incentives for investing in new drugs, which would endanger the “innovation that characterizes our industry.”
Pfizer is the first major pharmaceutical company to publicly react to the ruling. Merck, Moderna, Eli Lilly and Johnson & Johnson did not immediately respond to requests for comment.
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 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.
The FDA approved mifepristone in 2000. Medication abortion has become the most accessible and preferred method for terminating a pregnancy in the U.S. since then, accounting for more than half of all abortions nationwide.
The FDA did not immediately respond to a request for comment.
Mifepristone will be available in the short term because Kacsmaryk delayed his order for a week to give the Biden administration time to appeal.
Kacsmaryk’s decision conflicts with a ruling by a federal judge in Washington state. Less than an hour after the Texas ruling, the Washington state judge issued a preliminary injunction that could protect access to mifepristone in the 17 states and Washington, D.C., that brought a lawsuit arguing that too many regulations exist on the drug.
The dueling orders by two federal judges create a complicated legal standoff that could potentially escalate to the Supreme Court.
— CNBC’s Meg Tirrell and Spencer Kimball contributed to this report.
Read the full article here
