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

Scholarly Works

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 …

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

Scholarly Works

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

Scholarly Works

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 …