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Full-Text Articles in Law
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
University of Michigan Journal of Law Reform
Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …
Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn
Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn
Michigan Journal of Race and Law
With one of the highest incidence rates in the world, the HIV/AIDS epidemic has taken a large toll on South Africa. Despite medical advances that have made the disease more manageable, many South Africans still do not have access to the medicines needed to control the disease. At the same time, the Constitution of South Africa grants individuals far-reaching socioeconomic rights, including the right to access health care. This Comment explores the intersection of the socioeconomic rights and the HIV/AIDS crisis. Although the Constitutional Court has developed a deferential approach to enforcing socioeconomic rights, substantial room remains to litigate on …
Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang
Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang
University of Michigan Journal of Law Reform
Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …
Breaking Patents, Daniel R. Cahoy
Breaking Patents, Daniel R. Cahoy
Michigan Journal of International Law
In the 1970s and 1980s, the Boeing aircraft company worked to address the rising cost of jet fuel by inventing lighter metal alloys for use in aerospace materials. Among its discoveries was a method of producing aluminum-lithium alloys with high "fracture toughness," and in 1989, Boeing received a patent for the process. Five years later, another aerospace company working as a National Aeronautics and Space Administration (NASA) contractor, Lockheed Martin, was attempting to solve a similar problem related to materials used in the space shuttle. Lighter materials were necessary for future shuttle missions to transport components of the International Space …
Public Non-Commercial Use' Compulsory Licensing For Pharmaceutical Drugs In Government Health Care Programs, Pier Deroo
Public Non-Commercial Use' Compulsory Licensing For Pharmaceutical Drugs In Government Health Care Programs, Pier Deroo
Michigan Journal of International Law
Suppose a relatively prosperous nation with universal public health coverage faces an HIV/AIDS crisis. It refuses to negotiate with the patent-holding manufacturers of the best antiretrovirals (ARVs) available, instead issuing compulsory licenses. Compulsory licenses permit the generic drug manufacturers designated in the compulsory licenses to make, use, import, and sell the patented ARVs without the permission of the patent owners, increasing competition and lowering prices. Realizing that drugs are much cheaper without patents, the nation decides to issue another round of compulsory licenses for an extensive list of patented drugs for its universal health care program. While improving public access …
Teva V. Eisai: What's The Real Controversy, Grace Wang
Teva V. Eisai: What's The Real Controversy, Grace Wang
Michigan Telecommunications & Technology Law Review
This Note examines the changing role of declaratory judgment actions in challenging patents upon generic entry and evaluates alternative regulatory schemes to the FDA's current system of patent enforcement in the drug approval setting. Part I reviews the Federal Circuit's recent decisions regarding generic drug entry, focusing on how the courts justify declaratory judgments in the current system and when a "controversy" exists to create Article III jurisdiction. Part II examines the complex system of regulating generic drug entry and how attempts to stop the exploitation of loopholes have resulted in a patchwork of regulation by various parties. It challenges …
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Michigan Telecommunications & Technology Law Review
Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …
Falling Through The Crack: How Courts Have Struggled To Apply The Crack Amendment To Nominal Career And Plea Bargain Defendants, Maxwell Arlie Halpern Kosman
Falling Through The Crack: How Courts Have Struggled To Apply The Crack Amendment To Nominal Career And Plea Bargain Defendants, Maxwell Arlie Halpern Kosman
Michigan Law Review
Under the Federal Rules of Criminal Procedure, a defendant is normally obligated to attend all of the proceedings against her. However Rule 43(b)(2) carves out an exception for organizational defendants, stating that they "need not be present" if represented by an attorney. But on its face, the language of 43(b)(2) is ambiguous: is it the defendant or the judge who has the discretion to decide whether the defendant appears? That is, may a judge compel the presence of an organizational defendant? This Note addresses the ambiguity in the context of the plea colloquy, considering the text of several of the …