https://www.wsj.com/articles/the-fda-wants-to-interfere-in-the-practice-of-medicine-physicians-patients-medical-devices-treatment-11673562165?mod=opinion_lead_pos7
Secreted within the 2023 omnibus appropriations bill—4,155 pages, spending $1.7 trillion—is a 19-line section that could change the way medicine is practiced.
Physicians routinely prescribe drugs and employ medical devices that are approved and labeled by the Food and Drug Administration for a particular use. Yet sometimes physicians discern other beneficial uses for these technologies, which they prescribe for their patients without specific official sanction. The new legislation amends the Food, Drug and Cosmetic Act, or FDCA, to give the FDA the authority to ban some of these off-label uses of otherwise approved products. This unwarranted intrusion into the physician-patient relationship threatens to undermine medical innovation and patient care.
The new provision was enacted at the FDA’s urging in response to a decision by the U.S. Circuit Court of Appeals for the District of Columbia. The case, Judge Rotenberg Education Center v. FDA, involved a 2020 final rule in which the FDA banned the use of an electrical stimulation device, only in the treatment of self-injurious behaviors such as head banging and self-biting. The agency didn’t ban other uses of these devices, such as treating addiction.
The court held that the FDA had the power to ban a medical device altogether under Section 360f of the FDCA if it poses “an unreasonable and substantial risk of illness or injury.” But barring a practitioner from prescribing or using an otherwise approved device for a specific off-label indication would violate another FDCA section, which bars the FDA from regulating the “practice of medicine.”
