The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to the conventional wisdom, the federal government is deeply entangled in regulating medical practice, and such federal regulation is lawful. After examining the goals of federalism within the context of medicine, the Article proposes an alternate paradigm for guiding decisions about the division of labor between states and the federal government: Congress and administrative agencies should exert federal authority when medical practice contributes to a national public health problem for which state regulation is inadequate. This framework is applied to one pressing public health problem to which medical practice contributes – antibiotic resistance – to show how the framework could be implemented. Federal oversight of medical practice under this framework would be more principled and transparent than the scheme of federal control that is in place today.
Toward Coherent Federal Oversight of MedicineSan Diego Law Review
Citation InformationPatricia J. Zettler, Toward Coherent Federal Oversight of Medicine, 52 San Diego Law Review 427 (2015).