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Articles 1 - 6 of 6
Full-Text Articles in Law
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
University of Michigan Journal of Law Reform
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.
Regulating By Repute, David Zaring
Regulating By Repute, David Zaring
Michigan Law Review
Is regulation a hopeless cause? Many thoughtful observers spend a lot of time enumerating all of the reasons why it is doomed to fail. The entire field of public choice, with impeccable logic, posits the likely corruption of every bureaucrat. And if corruption cannot explain the failure of regulation, the atrophy that comes from lack of competition-there is just one government, after all, and it does not have a profit motive-may be just as rich a vein to mine. It could also be that the legal system itself, with its myriad complexities, checks, and procedural requirements, may ossify to the …
Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System, Amy Murphy
Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System, Amy Murphy
Michigan Law Review
In Granholm v. Heald, the Supreme Court held that states must treat instate and out-of-state alcoholic beverages equally under the dormant Commerce Clause and established a heightened standard of review for state alcohol laws. Yet in dictum the Court acknowledged that the three-tier distribution system-a regime that imposes a physical presence requirement on alcoholic beverage wholesalers and retailers-was "unquestionably legitimate." Though the system's physical presence requirement should trigger strict scrutiny, lower courts have placed special emphasis on Granholm's dictum, refusing to subject the three-tier distribution system to Granholm's heightened standard of review. This Note argues that the dictum should be …
Every High Has A Low: A Pragmatic Approach To The War On Drugs, Mark Garibyan
Every High Has A Low: A Pragmatic Approach To The War On Drugs, Mark Garibyan
University of Michigan Journal of Law Reform Caveat
One of the lasting vestiges of Richard Nixon’s presidency is the infamous “War on Drugs,” a forty-year-old effort aimed at curtailing “illicit drug consumption and transactions in America.” Although the goal behind the policy—a reduction in the rate of substance abuse—may be altruistic, the War on Drugs has dismally failed to achieve its goals and has exacerbated existing problems. Specifically, laws dealing with crack cocaine result in a “heavily disproportionate impact on black defendants;” in 2008 “blacks comprised 79.8 percent of those convicted for crack cocaine-related offenses,” whereas “whites comprised only 10.4 percent.” More generally, these laws illustrate a fundamental …
Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson
Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson
University of Michigan Journal of Law Reform Caveat
Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.” The recent outbreak was caused …
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Michigan Telecommunications & Technology Law Review
Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …