More than 300 current and former pharmaceutical industry executives signed a letter Monday opposing the ruling last week by a Texas federal judge that would reverse the Food and Drug Administration’s 23-year-old approval of the most commonly used abortion pill.

What You Need To Know

  • More than 300 current and former pharmaceutical industry executives signed a letter Monday opposing the ruling last week by a Texas federal judge that would reverse the Food and Drug Administration’s 23-year-old approval of the most commonly used abortion pill

  • The executives said they “unequivocally support” the FDA’s authority to regulate medicines. The letter was signed by top executives at some of the biggest pharmaceutical companies, including Pfizer, Bayer, Merck and Novartis

  • The FDA and leading medical associations have said the drug is completely safe. In an amicus brief, the American Medical Association wrote the drug is one of the most studied medications prescribed in the country and its safety is “on par with common painkillers like ibuprofen and acetaminophen"
  • One of the pharmaceutical industry’s central concerns is that if a judge can overturn FDA approval of this drug, all drugs are vulnerable to similar rulings

“The decision ignores decades of scientific evidence and legal precedent,” the letter reads, adding that District Judge Matthew Kacsmaryk has “no scientific training.” 

“We cannot stay quiet. 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 executives said they “unequivocally support” the FDA’s authority to regulate medicines. The letter was signed by top executives at some of the biggest pharmaceutical companies, including Pfizer, Bayer, Merck and Novartis.

Pfizer CEO and Chairman Dr. Albert Bourla signed the letter himself.

In his decision, Kacsmaryk put the FDA’s approval of mifepristone on hold over safety concerns, with a stay of his ruling for seven days.

The FDA and leading medical associations have said the drug is completely safe. In an amicus brief, the American Medical Association wrote the drug is one of the most studied medications prescribed in the country and its safety is “on par with common painkillers like ibuprofen and acetaminophen.”

The letter from pharmaceutical executives echoed those statements, saying mifepristone “has been proven by decades of data to be safer than Tylenol, nearly all antibiotics and insulin.”

A judge in Washington state made the opposite decision shortly after Kacsmaryk’s ruling, ordering the federal government to not make any changes that would restrict access to the medication in 17 Democratic states.

One of the pharmaceutical industry’s central concerns is that if a judge can overturn FDA approval of this drug, all drugs are vulnerable to similar rulings.

“Judicial activism will not stop here,” the letter reads. “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.”

White House Press Secretary Karine Jean-Pierre said Monday the ruling “could open the floodgates for other medications to be targeted and denied to people who need them.”

Health and Human Services Secretary Xavier Becerra expressed the same concerns on Sunday.

“When you turn upside down the entire FDA approval process, you’re not talking about just mifepristone, you’re talking about every kind of drug,” Becerra said on CNN’s “State of the Union.” “You’re talking about our vaccines, you’re talking about insulin, you’re talking about the new Alzheimer’s drugs that may come on. If a judge decides to substitute his preference, his personal opinion for that of scientists and medical professionals, what drug isn’t subject to some kind of legal challenge?”

Some progressive Democratic lawmakers — including Rep. Alexandria Ocasio-Cortez, D-N.Y., and Sen. Ron Wyden, D-Ore. — have called for the FDA to just ignore the Texas ruling and continue operating business as usual. One Republican, South Carolina Rep. Nancy Mace, agreed with the progressives that the FDA should ignore Kacsmaryk’s decision.

“This is an FDA approved drug. Whether you agree with its usage or not, that's not your decision. That is the FDA’s decision,” Mace said on CNN on Monday.

Other Democrats argue the best path forward is to continue to fight the ruling in the courts.

Becerra didn’t rule anything out Sunday, but expressed hope, with the stay of seven days, appeals will result with a desirable ruling for the Biden administration this week.

The Department of Justice on Monday asked an appeals court for an emergency stay, blocking Kacsmaryk’s ruling and maintaining the status quo until the process can play itself out in the courts.

The Texas decision is likely to reach the Supreme Court, which undid the 50-year-old precedent of Roe v. Wade last year.