Top 9 Lawarxiv Papers Today in Medicine And Health Sciences


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#1. Hospital Mergers and Public Accountability: Tennessee and Virginia Employ a Certificate of Public Advantage
Georgia State Law Submitter, Erin C. Fuse Brown
Rapid health care consolidation has led to rising health care prices, diminished access to care, and reduced incentives for quality improvement. States have a variety of tools to address these adverse consequences of the loss of health care competition, ranging from state antitrust enforcement to global budgets or provider rate-regulation. One of the tools is a “certificate of public advantage” (COPA) or cooperative agreement under which the state approves a health care merger and shields it from antitrust enforcement in exchange for state oversight and supervision of the merged entities’ conduct. COPAs are controversial. The Federal Trade Commission and economists vehemently oppose COPAs, citing evidence that health care consolidation leads to higher prices and does not yield efficiencies, savings, or improved quality. The risks of COPAs are that they create, in essence, a state-sanctioned monopoly that could significantly raise prices, reduce consumer choice and access, and disinvest in essential services that may be less...
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Authors: 2
Total Words: 17523
Unqiue Words: 3988

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#2. Implementing a Public Health Perspective in FDA Drug Regulation
Georgia State Law Submitter, Patricia Zettler, Margaret Foster Riley, Aaron S. Kesselheim
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 of drugs is often understood as narrowly focused on weighing the benefits and risks of the products as defined in the preapproval clinical trials that are used to set the drug’s official FDA-approved indication. Such a limited focus would exclude important information about the real-world use and public-health impact of prescription opioids and other drugs with externalities. This Article...
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Authors: 4
Total Words: 20100
Unqiue Words: 5622

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#3. Paying for Suffering: The Problem of Human Experimentation
Larry I. Palmer, Cornell Law Library
56 Maryland Law Review 604 (1997)
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Authors: 2
Total Words: 160
Unqiue Words: 27

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#4. Who Let the Dog Out? Implementing a Successful Therapy Dog Program in an Academic Law Library
Cornell Law Library, Femi Cadmus, Julian Aiken
The motivation for introducing a therapy dog to the Yale Law Library was twofold. Inarguably, attending law school can sometimes be stressful. Studies indicate that, particularly in the first year of law school, when newcomers are adjusting to new teaching methods, materials, external and internal expectations, and even geographic locations, students can experience elevated stress levels. The evidence that visits from therapy dogs have resulted in increased happiness, calmness, and overall emotional well-being was a strong factor in proposing the introduction of Monty, the therapy dog, to the stacks: the health and general happiness of the students in our school is of paramount importance to the Yale Law School and Library.
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Authors: 3
Total Words: 1794
Unqiue Words: 911

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#5. Cross-Market Mergers in Healthcare: Adapting Antitrust Regulation to Address a Growing Concern
Thaddeus J. Lopatka, Cornell Law Library
102 Cornell L. Rev. 821 (2017) In the United States, the FTC and the Antitrust Division of the Department of Justice together serve to keep domestic markets free and competitive for the benefit of American consumers. One such way these antitrust regulators maintain and enforce free competition is by blocking potential mergers between competing firms that would result in higher prices or lower quality products without creating offsetting positive efficiencies. Thus, merger review by antitrust enforcers inherently involves weighing the procompetitive benefits of mergers against the anticompetitive consequences. Since 1968, the antitrust regulators have evaluated the procompetitive and anticompetitive effects of mergers under the framework of the Horizontal Merger Guidelines. Mergers between firms that operate in separate and distinct geographic areas, known as “cross-market mergers,” present a unique challenge to antitrust regulators in performing this balancing test, as the anticompetitive effects of such mergers are...
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Authors: 2
Total Words: 12638
Unqiue Words: 3005

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#6. The Indirect Consequences of Expanded Off-Label Promotion
Georgia State Law Submitter, Patricia Zettler
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 suggested in the dissenting opinion in United States v. Caronia, a high-profile 2012 case regarding off-label promotion—protections for off-label promotion might affect the FDA’s decision-making in areas other than drug promotion, and analyzes precisely what those effects could be in light of the FDA’s current statutory authority. Citation:...
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Authors: 2
Total Words: 22271
Unqiue Words: 5705

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#7. Unquantified Benefits and the Problem of Regulation under Certainty
Jonathan S. Masur, Eric A. Posner, Cornell Law Library
102 Cornell Law Review 87 (2016) Regulatory agencies are required to perform cost-benefit analysis of major rules. However, in many cases regulators refuse to report a monetized value for the benefits of a rule that they issue. Sometimes, they report no monetized value; at other times, they report a monetized value but also state that not all benefits have been quantified. On occasion, regulators also refuse to monetize or fully monetize costs. These practices raise a puzzle. If a regulator chooses not to monetize all the benefits or all the costs, it is not doing cost-benefit analysis. If it is not doing cost-benefit analysis, what is it doing? To investigate this question, we compiled a data set consisting of all major regulations issued by agencies from 2010 to 2013. We come to three conclusions. First, there are countless examples where agencies fail to fully monetize the benefits and costs of regulations. Second, in most cases, agencies could easily monetize or partially monetize those benefits and costs. Third, even where...
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Authors: 3
Total Words: 21725
Unqiue Words: 5230

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#8. Can DNA Be Speech?, 33 Cardozo Arts & Ent. L.J. 163 (2016)
Jorge R. Roig
DNA is generally regarded as the basic building block of life itself. In the most fundamental sense, DNA is nothing more than a chemical compound, albeit a very complex and peculiar one. DNA is an information-carrying molecule. The specific sequence of base pairs contained in a DNA molecule carries with it genetic information, and encodes for the creation of particular proteins. When taken as a whole, the DNA contained in a single human cell is a complete blueprint and instruction manual for the creation of that human being. In this article we discuss myriad current and developing ways in which people are utilizing DNA to store or convey information of all kinds. For example, researchers have encoded the contents of a whole book in DNA, demonstrating the potential of DNA as a way of storing and transmitting information. In a different vein, some artists have begun to create living organisms with altered DNA as works of art. Hence, DNA is a medium for the communication of ideas. Because of the ability of DNA to store and convey...
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Authors: 1
Total Words: 23313
Unqiue Words: 6331

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#9. Closing the Regulatory Gap for Synthetic Nicotine
Georgia State Law Submitter, Patricia Zettler, Natalie Hemmerich, Micah L. Berman
In July 2017 the U.S. Food and Drug Administration (FDA) announced a new “comprehensive plan for tobacco and nicotine regulation.” This plan is focused on making cigarettes less addictive while facilitating the development of alternative nicotine-containing products that are far less harmful. This approach holds promise, and the public health stakes could not be higher—smoking is the leading cause of preventable death in the United States, causing roughly 480,000 deaths per year. But a new product is emerging that could upset the FDA’s plans for a well-balanced regulatory scheme: synthetic nicotine. These products currently fall into a regulatory gap because they fall outside the Federal Food, Drug, and Cosmetic Act’s (FDCA) definition of a tobacco product. If this gap remains in place, it is likely that more companies will exploit it in order to evade regulation, undoing the potential benefits of the FDA’s plan for tobacco and nicotine regulation. This Article argues that the FDA can, and should, address this problem...
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Authors: 4
Total Words: 18506
Unqiue Words: 4770

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