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Articles 1 - 10 of 10
Full-Text Articles in Food and Drug Law
3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom
3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom
Evan R. Youngstrom
Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …
Gandhi’S Prophecy: Corporate Violence And A Mindful Law For Bhopal, Nehal A. Patel
Gandhi’S Prophecy: Corporate Violence And A Mindful Law For Bhopal, Nehal A. Patel
Nehal A. Patel
AbstractOver thirty years have passed since the Bhopal chemical disaster began,and in that time scholars of corporate social responsibility (CSR) havediscussed and debated several frameworks for improving corporate responseto social and environmental problems. However, CSR discourse rarelydelves into the fundamental architecture of legal thought that oftenbuttresses corporate dominance in the global economy. Moreover, CSRdiscourse does little to challenge the ontological and epistemologicalassumptions that form the foundation for modern economics and the role ofcorporations in the world.I explore methods of transforming CSR by employing the thought ofMohandas Gandhi. I pay particular attention to Gandhi’s critique ofindustrialization and principle of swadeshi (self-sufficiency) …
Closing The Door To Lost Earnings Under The National Childhood Vaccine Injury Act Of 1986, Aaron M. Levin
Closing The Door To Lost Earnings Under The National Childhood Vaccine Injury Act Of 1986, Aaron M. Levin
Aaron M Levin
After a wave of lawsuits against vaccine manufacturers hindered the profitability and production of life-saving vaccines, Congress enacted The National Childhood Vaccine Injury Act of 1986. The Act offers an incentive for individuals to get vaccinated in order to mitigate the population’s exposure to disease, while encouraging the continued production of these serums by pharmaceutical companies. Although imperfect, the Vaccine Act fosters promise in filtering out frivolous claims and provides a central route for due process to the individuals who suffer from a vaccine-related injury. By removing a potential state tort issue to the Federal Circuit, Congress created a reasonably …
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah W. Brennan
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah W. Brennan
Hannah W Brennan
The United States spends nearly $1,000 per person annually on drugs—40 percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, the crucial role that intellectual property laws play in inhibiting access to cheaper, generic medications is among one of the best documented. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different exclusivity—trademark law. New …
The Drug Shortage Crisis: What Happens When Generic Manufacturers "Just Say No", Stacey B. Lee
The Drug Shortage Crisis: What Happens When Generic Manufacturers "Just Say No", Stacey B. Lee
Stacey B. Lee
In the past five years, the number of drug shortages in the United States has nearly quintupled. The majority of shortages involve generic sterile injectables used to fight infectious diseases and treat cancer. These complex drugs are produced in a concentrated market consisting of only a few generic manufacturers. Any disruption in their supply can result in shortages that leave patients without access to life-saving drugs which in some cases are the only treatment for their condition. These chronic shortages have been linked to many possible factors including product quality concerns, discontinuation of product lines, changes in supply and demand, …
The Smokable Goods Tax: Crafting A Constitutional Marijuana Tax, Nima H. Mohebbi, Samuel T. Greenberg
The Smokable Goods Tax: Crafting A Constitutional Marijuana Tax, Nima H. Mohebbi, Samuel T. Greenberg
Nima H. Mohebbi
Marijuana legalization and decriminalization has become a hot policy issue. Roughly twenty U.S. states have partially legalized marijuana (generally for medicinal purposes) and two states – Colorado and Washington – have legalized it for general adult recreational use. Given the likely hyper-growth of the cannabis market in view of the possible wide-scale legalization of marijuana, states might enjoy a potential budgetary windfalls from marijuana excise taxes. Marijuana, however, remains a federally controlled substance, the sale or use of which is subject to substantial penalties. For the states, this presents a potential problem in collecting excise taxes on marijuana – namely, …
Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker
Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker
Chad I Brooker
Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …
Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower
Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower
Richard Cameron Gower
Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …
Innovation Cooperation: Energy Biosciences And Law, Prof. Elizabeth Burleson
Innovation Cooperation: Energy Biosciences And Law, Prof. Elizabeth Burleson
Prof. Elizabeth Burleson
This Article analyzes the development and dissemination of environmentally sound technologies that can address climate change. Climate change poses catastrophic health and security risks on a global scale. Universities, individual innovators, private firms, civil society, governments, and the United Nations can unite in the common goal to address climate change. This Article recommends means by which legal, scientific, engineering, and a host of other public and private actors can bring environmentally sound innovation into widespread use to achieve sustainable development. In particular, universities can facilitate this collaboration by fostering global innovation and diffusion networks.
Healthy Competition: What’S Holding Back Health Care And How To Free It, Michael F. Cannon
Healthy Competition: What’S Holding Back Health Care And How To Free It, Michael F. Cannon
Michael F. Cannon
No abstract provided.