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Full-Text Articles in Administrative Law
Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim
Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim
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There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …
Pharmaceutical Federalism, Patricia J. Zettler
Pharmaceutical Federalism, Patricia J. Zettler
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There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …
The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler
The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler
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The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …
Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler
Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler
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No abstract provided.
Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler
Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler
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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 …