Senior executives of more than 250 pharmaceutical and biotech companies on Monday issued a scorching condemnation of a ruling by a federal judge that invalidated the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, and they called for the decision to be reversed.
“The decision ignores decades of scientific evidence and legal precedent,” said the letter, which was signed by leaders of some of the industry’s most prominent companies, including Albert Bourla, chief executive of Pfizer, and Alisha Alaimo, president of Biogen.
The ruling, by Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, “has set a precedent for diminishing F.D.A.’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” the letter argues.
The letter also said that pharmaceutical companies rely on the F.D.A.’s autonomy to bring products to market under a “reliable regulatory process for drug evaluation and approval.”
“If courts can overturn drug approvals without regard for science or evidence,” the letter said, “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.”
