Pharma Leaders Rebuke Federal Judge’s Ruling on FDA Authority

On April 10, 2023, members of more than 250 pharmaceutical companies and investment firms, including Albert Bourla, CEO of Pfizer, released a statement decrying a court decision regarding FDA’s long-standing approval of mifepristone, a medication used to terminate pregnancies through ten weeks of gestation. Matthew Kacsmaryk, a Texas district judge, ruled in favor of the plaintiffs, a coalition of anti-abortion groups, who argued that the drug’s approval should be revoked because it does not convey a “therapeutic benefit” to women who use it.

The letter offered a harsh rebuke of the decision and called for a reversal of the decision. According to the letter, the decision ignored “decades of scientific evidence and legal precedent” and “creates uncertainty for the entire biopharma industry.” Should the decision withstand further judicial scrutiny, the signatures worry that it could “fundamentally undermine the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American.”

“Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, 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,” reads the statement. "While the drug development, approval, and monitoring process is not perfect, the [a]gency’s framework has resulted in decades of unsurpassed medical innovation and in statutory mechanisms to remove drugs from the market if, among other reasons, they fail to maintain the anticipated safety and efficacy profile.”

The letter can be read in its entirety here.