“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 CEOs wrote in the letter.

The CEO of pharma giant Pfizer, Albert Bourla, signed the letter, along with hundreds of smaller American biotech companies, including ReCode Therapeutics, Blackfynn, and Ovid Therapeutics. 

Roe v. Wade was overturned by the U.S. Supreme Court last summer, which had previously granted access to abortion health care nationwide. In the aftermath of that reversal, states independently decided whether or not abortion would be allowed or effectively banned. 

Last Friday, Trump-appointed U.S. District Judge Matthew Kacsmaryk ordered a suspension of the federally approved mifepristone, a drug that has been used for over two decades to terminate pregnancies. On the same day, Washington State’s U.S. District Judge Thomas O. Rice, who was appointed by the Obama administration, called for the opposite and directed the FDA not to roll back the abortion pill. 

“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 CEOs’ letter says. 

The Justice Department has asked the federal appeals court to hold off on Kacsmaryk’s ruling, calling it “misguided.” The immediate effects of Kacsmaryk’s order is not clear yet, as it is meant to go into effect this Friday.

Role of abortion pill

Mifepristone was first approved in 2000 for use within seven weeks of pregnancy (expanded to 10 weeks in 2016) to end a pregnancy. The drug is part of a two-pill regimen, along with ​​misoprostol, which has been widely used by doctors in the U.S. for abortion using medication alone. 

If the sale of mifepristone is suspended, that will leave abortion-seekers with two avenues—a surgical procedure, which is now effectively banned in many states, or only misoprostol, which has been found to be less effective than the original two-drug combination.

Experts say that banning the pill would also undermine the power of the FDA in the drug-approval process and could steer pharma companies away from abortion medications to focus instead on easier drugs that don’t present a legal quagmire.

Kacsmaryk said his reasoning for suspending access to the abortion pill concerned the health and safety of women, who died or suffered some form of injury from mifepristone. He accused the FDA of acquiescing to “pressure to increase access to chemical abortion at the expense of women’s safety.”