Law Commons^™

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to …

Can You Really Keep Your Health Care Plan? The Limits Of Grandfathering Under The Affordable Care Act, Elizabeth Weeks Leonard

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This article examines the rhetoric and reality of President Obama's repeated hallmark promise during federal health reform that "you can keep your health plan," as one example of the Administration's equivocal stance toward deregulation. Although rhetorically supporting the popular preference for decreased government involvement in health care, the Obama Administration, in several instances, has achieved significant re-regulation through the intricacies of executive branch rule-making. The Affordable Care Act's "grandfather rule" (Section 1251, "Preservation of Right to Maintain Existing Coverage") purports to uphold the "you can keep your health plan" promise. But the regulatory requirements for plans to retain grandfathered status …

Scientific Understandings Of Postpartum Illness: Improving Health Law And Policy?, Stacey A. Tovino

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In its broadest sense, the Article examines the relationship between science and the law in the context of postpartum illness. From classical antiquity to the present day, physicians and scientists have investigated the causes, correlates, and consequences of the depressions and psychoses that develop in some women following their transition to motherhood. The scientific investigation of postpartum illness has been characterized by an open-ended search for knowledge with the recgonition that scientific findings published one day are subject to revision the next. Legislators and judges also have sought to understand postpartum illness as necessary to make laws that affect and …

Remarks: Neuroscience, Gender, And The Law, Stacey A. Tovino

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These remarks, delivered at the Neuroscience, Law, and Government Symposium held at the University of Akron School of Law in 2009, explore how stakeholders are using advances in the neuroscience of three gender-specific and gender-prevalent conditions (the postpartum mood disorders, premenstrual dysphoric disorder, and eating disorders) to secure health care benefits under group health plans and individual health insurance policies and to push for the inclusion of these conditions in mental health parity legislation.

Neuroscience And Health Law: An Integrative Approach?, Stacey A. Tovino

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Neuroscience is one of the fastest growing scientific fields in terms of the numbers of scientists and the knowledge being gained. In recent years, both the scope of neuroscience and the methodologies employed by nueroscientists have broadly expanded, from biochemical and genetic analysis of individal nerve cells and their molecular constituents, to the recent neuroscientific achievement in the ability of neuroimaging technoloiges, including funtional magnetic resonance imaging (fMRI), to image brain function. Clinicans and scientists use fMRI not only to map sensory, motor, and cognitive function, but also to study the neural correlates of a range of physical and mental …

Cooperative Federalism And Healthcare Reform: The Medicare Part D 'Clawback' Example, Elizabeth Weeks Leonard

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This symposium article recounts recent litigation by several states over a provision of the Medicare Modernization Act Part D prescription drug benefit: The clawback, which requires states to pay the a potentially substantial portion of new federal program. I then examine the unique federalism implications of the clawback for ongoing state and federal health reform initiatives.

In spring 2006, several states petitioned the United States Supreme Court for original jurisdiction to hear a challenge to one provision of the new Medicare Part D prescription drug law. The federal government, while taking over prescription drug coverage for dually eligible beneficiaries, required …

Gauging The Cost Of Loopholes: Health Care Pricing And Medicare Regulation In The Post-Enron Era, Elizabeth Weeks Leonard

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This article explores the problem of risk perception and regulatory loopholes in the unique era of corporate governance that followed Enron and other high-profile corporate scandals. The article draws on behavioral law and economics theory to examine pressing issues in U.S. welfare policy reform. The current Administration's domestic agenda features proposals to privatize traditional government welfare programs, including Social Security and Medicare. Those proposals rely on market competition and other profit incentives to improve quality and reduce program costs. The article traces a detailed case study of a prominent for-profit hospital corporation, the impact of public perceptions of corporate wrongdoing, …

Is It Worth The Trouble? The New Policy On Dissemination Of Information On Off-Label Use Under The Food And Drug Administration Modernization Act Of 1997, Elizabeth Weeks Leonard

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On January 14, 1998 the Food and Drug Administration (FDA) approved the use of a product previously marketed as Excedrin Extra Strength^® for use in treating migraine headaches. As part of the approval for the new use of the product, FDA required the pharmaceutical manufacturer of Excedrin^®, Bristol-Myers Squibb, to relabel and repackage the product. The new product is called “Excedrin Migraine^®” and is sold side-by-side with Excedrin Extra Strength^®. Both over-the-counter (OTC) products contain the same active ingredients: 250 milligrams of acetaminophen, 250 milligrams of aspirin, and sixty-five milligrams of caffeine. Many …