Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, 2010 University of Missouri School of Law
Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan
On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from ...
Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, 2010 University of Richmond
Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa
Richmond Public Interest Law Review
In the recent landmark decision in Wyeth v. Levine, the Supreme Court put drug manufacturers on notice that they can and should be liable for state tort claims for the harm their products cause regardless of Federal Drug Administration ("FDA") approval of the drug's use and warning labels. Part II of this paper analyzes the history and background of federal preemption to give context to the current environment after Wyeth. Part III analyzes the Supreme Court's decision in Wyeth, holding that the FDCA and corresponding regulations do not preempt state tort claims. Finally, Part IV discusses and analyzes ...
"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, 2010 University of Michigan Law School
"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane
Congratulations to Mike on a very fine book. I will confine my comments to Mike's chapter on patent settlements (Chapter 15), which I understand will also be coming out as an article in the Michigan Law Review. Patent settlements involving "reverse payments" are a huge topic on which I and many others have spilled much ink already. Representative Bobby Rush (President Obama's erstwhile nemesis from Chicago's South Side) has just introduced legislation that would ban reverse payments.' I will not regurgitate my entire spiel on patent settlements here, but instead just try to highlight my essential disagreement ...
Between Starvation And Globalization: Realizing The Right To Food In India, 2010 Harvard Law School
Between Starvation And Globalization: Realizing The Right To Food In India, Lauren Birchfield, Jessica Corsi
Michigan Journal of International Law
This Article evaluates People's Union for Civil Liberties v. Union of India & Others (PUCL) through multiple lenses, examining: (1) the necessary factors that contributed to the success of the Public Interest Litigation (PIL) and its enforcement and (2) both the implications and limitations of PUCL as it relates to India's larger economic policy framework. We argue that the development and success of the PUCL litigation have depended in part on provisions of the Indian Constitution amenable to the incorporation and promotion of economic and social rights as well as on a unique relationship between civil society and judicial ...
Private Regulation And Foreign Conduct, 2010 Penn State Law
Private Regulation And Foreign Conduct, Adam I. Muchmore
Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens ...
Making Changes: Generic Drug Labeling And The Case Against Federal Preemption, 2010 University of Kentucky
Making Changes: Generic Drug Labeling And The Case Against Federal Preemption, Lesley A. Stout
Kentucky Law Journal
No abstract provided.
From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, 2010 Georgia State University College of Law
From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah
Faculty Publications By Year
Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access ...
Two Masters, 2010 University of Michigan Law School
Two Masters, Carl E. Schneider
American government rests on the principle of distrust of government. Not only is power within the federal government checked and balanced. Power is divided between the federal government and the state governments. So what if a state law conflicts with a federal law? The Constitution says that the "Constitution, and the Laws of the United States ... shall be the supreme Law of the Land; ... any Thing in the ... Laws of any State to the Contrary notwithstanding." Sometimes the conflict between federal and state law is obvious and the Supremacy Clause is easily applied. But sometimes ...
We Can Work It Out: Co-Op Compulsory Licensing As The Way Forward In Improving Access To Anti-Retroviral Drugs, 2010 Elisabeth Haub School of Law at Pace University
We Can Work It Out: Co-Op Compulsory Licensing As The Way Forward In Improving Access To Anti-Retroviral Drugs, Horace E. Anderson
Pace Law Faculty Publications
This Article explores the social and developmental underpinnings of the access problem and describes the legal framework that provides the backdrop for the Waiver's licensing scheme. Part III examines the various lenses, humanitarian, economic, and political, through which the underutilization problem may be viewed and explained. Part IV sets out the structural heart of the Waiver scheme's deficiencies: the notion of the “compulsory” license itself. Part V posits a co-op scheme of licensing that aligns the concerns, goals, and incentives of IP owners, importers, exporters, and consumers. Finally, the Article relates the proposed scheme to more general trends ...
Bundling Public And Private Goods: The Market For Sustainable Organics, 2010 Elisabeth Haub School of Law at Pace University
Bundling Public And Private Goods: The Market For Sustainable Organics, Margot J. Pollans
Pace Law Faculty Publications
Modern agriculture has vast environmental externalities. The pesticides, fertilizers, and sediments in irrigation runoff pollute surface and groundwater; single-crop farms destroy biodiversity; and massive amounts of fossil fuels are burned in agricultural production, post-harvest processing, and shipping. Nevertheless, farming operations have largely escaped the post-1970 expansion of federal environmental regulation. Compounding the problem, federal farm policy has encouraged the very farming practices that most cause this degradation.
In 1990, Congress passed the Organic Foods Production Act (OFPA), which created an organic food certification and labeling system. While OFPA's primary purposes are to facilitate the growth of the organic sector ...
Reclaiming The Right To Food As A Normative Response To The Global Food Crisis, 2010 Elisabeth Haub School of Law at Pace University
Reclaiming The Right To Food As A Normative Response To The Global Food Crisis, Smita Narula
Pace Law Faculty Publications
In 2009, the number of hungry in the world crossed the one billion mark, a dubious milestone that has been attributed in large part to consecutive food and economic crises. Over ninety-eight percent of these individuals live in the developing world. Ironically, a great majority are involved in food production as small-scale independent food producers or agricultural laborers. These facts and figures signal a definitive blow to efforts to reduce global hunger and lift the world's poorest from abject and dehumanizing poverty. They also bring to light the deep imbalance of power in a fundamentally flawed food system. Responses ...