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Full-Text Articles in Law
Pharmaceutical Federalism, Patricia J. Zettler
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 …
Physician Encounters With Human Trafficking: Legal Consequences And Ethical Considerations, Jonathan Todres
Physician Encounters With Human Trafficking: Legal Consequences And Ethical Considerations, Jonathan Todres
Faculty Publications By Year
There is growing recognition and evidence that health care professionals regularly encounter - though they may not identify - victims of human trafficking in a variety of health care settings. Identifying and responding appropriately to trafficking victims or survivors requires not only training in trauma-informed care but also consideration of the legal and ethical issues that arise when serving this vulnerable population. This essay examines three areas of law that are relevant to this case scenario: criminal law, with a focus on conspiracy; service provider regulations, with a focus on mandatory reporting laws; and human rights law. In addition to …
The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler
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 …
Consumer Financial Protection In Health Care, Erin C. Fuse Brown
Consumer Financial Protection In Health Care, Erin C. Fuse Brown
Faculty Publications By Year
There are inadequate consumer protections from harmful medical billing practices that result in unavoidable, unexpected, and often financially devastating medical bills. The problem stems from the increasing costs shifting to patients in American health care and the inordinate complexity that makes health care transactions nearly impossible for consumers to navigate. A particularly outrageous example is the phenomenon of surprise medical bills, which refers to unanticipated and involuntary out-of-network bills in emergencies or from out-of-network providers at in-network facilities. Other damaging medical billing practices include the opaque and à la carte nature of medical bills, epitomized by added “facility fees,” as …