FDA’s Misguided Quest to Regulate the Practice of Medicine Implicates Serious Federalism Concerns

Published in WLF Legal Backgrounder, March 22,2024March 22, 2024 Download PDF

For over a decade, the Food and Drug Administration (FDA) has devoted extensive resources to banning the use of an FDA-cleared medical device that is being successfully used by medical doctors and other licensed health care professionals at one facility to treat approximately 50 patients in the nation who had failed all other therapies and are now healthy and thriving thanks to the device. Despite having lost once already in a federal Court of Appeals and despite having been provided with comprehensive real-world data showing the safety and effectiveness of the treatment, FDA has doggedly continued its unrelenting pursuit of this ban. Yet FDA’s efforts to ban one specific use of the device are not supported by science, impermissibly intrude on the ability of physicians to practice medicine and run afoul of the Tenth Amendment.

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