Hundreds of healthcare leaders have banded together in a public letter condemning a federal judge’s recent decision to suspend access to mifepristone, the most common method of abortion.
The letter was signed by Pfizer Chairman and CEO Albert Doula, PhD, Biogen President and CEO Chris Viehbacher and leaders from many other pharmaceutical companies, including Merck. The letter opposes the decision by Texas-based U.S. District Judge Matthew J. Kacsmaryk, who on April 7 ordered a stay on the drug to the Food and Drug Administration (FDA) while a lawsuit over the safety of the drug continues.
Mifepristone was approved by the FDA in 2000 and has become the most common abortion method in the U.S. It is also a common medication for miscarriage. It has been safely used for more than two decades before Kacsmaryk’s ruling.
Healthcare leaders who signed the letter voiced their concern over the precedent the ruling creates over the FDA’s ability to approve medicines and medical devices.
“District Judge Matthew Kacsmaryk issued a decision that overturns the FDA’s 23-year old approval of mifepristone, the primary medicine used in abortion and miscarriage care, and which has been proven by decades of data to be safer than tylenol, nearly all antibiotics and insulin,” the letter stated. “The decision ignores decades of scientific evidence and legal precedent. Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in doing so, creates uncertainty for the entire biopharma industry.”
The uncertainty the ruling creates could have a big impact on their industry, the biopharma leaders argued. In particular, if courts can interfere with the science and the approval process, biopharma companies could be less incentivized to develop new medications and therapies, they said.
"… Any medicine is at risk for the same outcome as mifepristone,” the letter stated. As a result of the ruling putting the entire medical innovation industry at risk, the leader stated they “cannot stay quiet.”
The letter called for a reversal of the decision, which the FDA and the Department of Justice have already appealed. Pfizer was the first major U.S. pharma company to sign the letter.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."