Modern medical innovations are blurring the line between medical practice and medical devices and drugs. Historically, many techniques have been developed in medicine, without any interference from the federal government, as medical practice is (and has historically been) an area of state jurisdiction. Over the past two decades, however, the U.S. Food and Drug Administration (FDA) has been exerting jurisdiction over the human body and the practice of medicine by targeting new medical techniques for oversight and subjecting the continued use of those treatments to onerous and legally questionable regulatory requirements that hinder the use of those treatments in practice.
This Article examines developing innovations in medicine and the life sciences, including gene editing (and CRISPR-Cas9, a system of gene editing that has been the subject of significant media coverage due to its wide-ranging potential uses), forms of assisted reproductive technology that could prevent the transmission of genetic diseases, stem cell therapies, and fecal microbiota transplants. The Article makes several claims. First, the Article argues that innovations in the life sciences largely fall outside of the jurisdiction of the FDA. Second, the FDA is applying a regime intended to regulate medical devices and pharmaceuticals to new innovations in the life sciences, which has a chilling effect on innovation and patient health. The Article also reveals that States—due to their historic police powers over the practice of medicine—retain a critical piece of jurisdiction over the life sciences such that the only method of accurately and adequately regulating the life sciences must include the States. Ultimately, it is critical that the regulatory apparatus surrounding the life sciences be improved, as the pace of innovation indicates that the regulation of the life sciences will continue to be salient in the near and distant future.
28 Utah Law Review 1073-1122 (2018)
Lewis, Myrisha S., "Halted Innovation: The Expansion of Federal Jurisdiction over Medicine and the Human Body" (2018). Faculty Publications. 1916.