On Monday, over 480 leaders from the biopharmaceutical industry came to the defense of the FDA and its approval of mifepristone. In an open letter, industry leaders showed their support for the FDA while questioning the merits of District Judge Matthew Kacsmaryk's preliminary injunction that would block the sale of a drug that has been used in women's healthcare for over two decades.
Referring to healthcare providers as "abortionists" and fetuses as "unborn children" and "unborn humans", there is little doubt where Judge Kacsmaryk stands on the issue of abortion. His 67-page ruling reads like medical expert cosplay.
Abortion issue aside, the idea of a judge removing an FDA-approved drug from the market should alarm us all. Allowing judicial interference in the FDA's authority exposes drug discovery and development to political headwinds, risks billions of biopharma dollars bringing new drugs to market, and ultimately jeopardizes patient health.
These are interesting days, certainly. It is good to see that biopharma leaders have the FDA's back and are willing to place themselves between medical science and judicial overreach.
In the open letter, industry leaders called for the reversal of Kacsmaryk’s decision, saying that it fundamentally undermined the FDA’s authority, granted by Congress, to approve and regulate medicines. Calling his ruling an “act of judicial interference,” the letter said that Kacsmaryk ignored the depth of scientific evidence backing mifepristone in his decision. Industry leaders also warned that Kacsmaryk’s decision set a legal precedent for biopharma and could open up other medicines for similar legal, politically-motivated challenges “without regard for science or evidence.”