More than 300 biotechnology and pharmaceutical executives have signed an open letter calling for a federal judge to reverse their decision to suspend sales of the abortion pill mifepristone, which is part of a two-drug regimen that accounts for more than half of US abortions.
Texas federal Judge Matthew Kacsmaryk on Friday suspended the US Food and Drug Administration’s (FDA's) 23-year-old approval of the drug, effectively banning the sale of the drug while a case by anti-abortion groups is heard in the Northern District of Texas.
The letter criticizes the judge’s decision, saying it “ignores decades of scientific evidence and legal precedent.”
“Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing the FDA’s authority over drug approvals, and in doing so, creates uncertainty for the entire biopharma industry,” the letter said.
“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 letter was written by ReCode Therapeutics CEO Shehnaaz Suliman, Blackfynn co-founder Amanda Banks, and Ovid Therapeutics CEO Jeremy Levin.
Among the letter’s signatories are Pfizer CEO Albert Bourla and representatives from Merck and Biogen, in addition to hundreds of executives from smaller US biotechnology companies.
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