Last week’s ruling undermines the FDA’s authority, the letter’s authors wrote, adding that it ignores decades of scientific evidence and legal precedent
CEO Albert Bourla, signed an open letter on Monday calling for reversal of a federal judge’s decision to suspend sales of the abortion pill mifepristone.
“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 decision puts the entire industry at risk, the letter says, and sets a precedent for undermining the agency’s authority to approve drugs, adding regulatory uncertainty that they warned would disincentivize investment in new treatments.
Health policy and legal experts have said that if Kacsmaryk’s unprecedented ruling is allowed to stand it could undermine confidence in FDA’s authority to regulate drugs, severely weaken the agency, and hinder access to new treatments.
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