Biotech Industry Aflame with Anger Over FDA-Overriding Mifepristone Ruling

A Texas federal judge’s pivotal decision to block the FDA’s long-standing green light for mifepristone, an abortion drug, has led to an uproar in the biotech community, with scores of executives and industry leaders sounding off on the controversial move. The U.S.’s leading medicine for inducing abortion and the recipient of an FDA approval for safety and efficacy that lasted 23 years, mifepristone was thought to be untouchable—until now. The ruling was almost immediately put in jeopardy, however, by a second decision from U.S. District Judge Thomas Rice in Washington, who instructed the FDA to preserve the drug’s status in the capital city as well as 17 states.

This situation has put U.S. District Judge Matthew Kacsmaryk deservedly in the hot seat, and he can expect to be handed a letter signed by top names in the healthcare industry. “Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” biotech executives wrote in an open letter that has to date amassed just shy of 300 signatures.

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It did not take long for the White House and Department of Health and Human Services (HHS) to put the wheels in motion to fight the ruling, nor House Democrats, who have already rustled up legislation to maintain the FDA’s overruling ability to approve drugs. The Department of Justice also weighed in, filing an official appeal in the Texas case. Labeling the ruling “regressive,” HHS Secretary Xavier Becerra believes it “opens the door for courts to overturn FDA’s evidence-based decisions for purely political or ideological reasons.”

Among the top-line industry bigwigs to provide their “John Hancock” to the open letter were leaders from the likes of Atlas Ventures, CRISPR Therapeutics, Absci, Vedanta Biosciences, and Bayer, among many others.