Law Commons^™

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

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

Faculty Publications By Year

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

Faculty Publications By Year

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 …

The Double-Edged Sword Of Health Care Integration: Consolidation And Cost Control, Erin C. Fuse Brown, Jaime S. King

Faculty Publications By Year

The average family of four in the United States spends $25,826 per year on health care. American health care costs so much because we both overuse and overpay for health care goods and services. The Affordable Care Act's cost control policies focus on curbing overutilization by encouraging health care providers to integrate to promote efficiency and eliminate waste, but the the cost control policies largely ignore prices. This article examines this overlooked half of health care cost control policy: rising prices and the policy levers held by the states to address them. We challenge the conventional wisdom that reducing overutilization …

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

The Impact Of Disability: A Comparative Approach To Medical Resource Allocation In Public Health Emergencies, Katie Hanschke, Leslie E. Wolf, Wendy F. Hensel

Faculty Publications By Year

It is a matter of time before the next widespread pandemic or natural disaster hits the United States (U.S.). The international response to the 2009 H1N1 influenza stands as a cautionary tale about how prepared the world is for such an emergency. Although the pandemic fortunately proved to be less severe than initially anticipated, it nevertheless resulted in shortages of medical equipment, overburdened hospitals, and preventable patient deaths, particularly among young people.

A pandemic will inevitably lead to difficult decisions about the allocation of medical resources, such as who will have priority access to ventilators and critical care beds when …

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

Faculty Publications By Year

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 …

When Harvard Said No To Eugenics: The J. Ewing Mears Bequest, 1927, Paul A. Lombardo

Faculty Publications By Year

James Ewing Mears (1838-1919) was a founding member of the Philadelphia Academy of Surgery. His 1910 book, The Problem of Race Betterment, laid the groundwork for later authors to explore the uses of surgical sterilization as a eugenic measure. Mears left $60,000 in his will to Harvard University to support the teaching of eugenics. Although numerous eugenic activists were on the Harvard faculty, and who of its Presidents were also associated with the eugenics movement, Harvard refused the Mears gift. The bequest was eventually awarded to Jefferson Medical College in Philadelphia. This article explains why Harvard turned its back …