Déjà Vu at the FDA

An op-ed in the Milbank Quarterly situating the Krebiozen affair within a longer pattern of FDA enforcement battles against unproven cancer remedies. Sharfstein notes that the 1965 Krebiozen trial lasted eight months with nearly 200 witnesses telling stories of miraculous cures, and ended in acquittal. The article also establishes the legislative context: the Kefauver-Harris Amendment of 1962, requiring manufacturers to demonstrate drug efficacy, was the law under which the FDA prosecuted Krebiozen, but the jury acquitted anyway.