Last week’s 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…
A US judge on Friday suspended the Food and Drug Administration’s two-decade-old approval of the drug, effectively banning sales while a case brought by anti-abortion groups before him continues in the Northern District of Texas.
“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,” they wrote. The letter was written by ReCode Therapeutics CEO Shehnaaz Suliman, Blackfynn co-founder Amanda Banks, and Ovid Therapeutics CEO Jeremy Levin, who is also a former chairman of biotech industry lobbying group BIO.
“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 letter said.
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