Food and Drug Law Commons^™

Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan

Faculty Publications

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 …

Deadly Delay / Postponed Pills, 10 J. Marshall Rev. Intell. Prop. L. 254 (2010), Christopher R. Walker

UIC Review of Intellectual Property Law

Since 1984, generic pharmaceuticals have continued to grow, and are an important element in our national struggle to increase affordable health care options in the United States. The Hatch-Waxman Act has played a pivotal role in helping to create a regulatory environment that fosters the development of generic pharmaceuticals, thereby increasing access to lower-cost alternatives to more expensive drugs. An important part of balancing the interests of the generic manufacturers against those of the primary pharmaceutical makers is the thirty-month stay provision of the Hatch-Waxman Act. This comment begins by taking a look at the history of the Hatch-Waxman Act …

Liberty Lost: The Moral Case For Marijuana Law Reform, Eric Blumenson, Eva Nilsen

Indiana Law Journal

Marijuana policy analyses typically focus on the relative costs and benefits of present policy and its feasible alternatives. This Essay addresses a prior, threshold issue: whether marijuana criminal laws abridge fundamental individual rights, and if so, whether there are grounds that justify doing so. Over 700, 000 people are arrested annually for simple marijuana possession, a small but significant proportion of the 100 million Americans who have committed the same crime. In this Essay, we present a civil libertarian case for repealing marijuana possession laws. We put forward two arguments corresponding to the two distinct liberty concerns implicated by laws …

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 institutions. …

Private Regulation And Foreign Conduct, Adam I. Muchmore

Faculty Scholarship

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 of …

Two Masters, Carl E. Schneider

Articles

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 ...

The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness

Law Faculty Scholarly Articles

On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. In …

We Can Work It Out: Co-Op Compulsory Licensing As The Way Forward In Improving Access To Anti-Retroviral Drugs, Horace E. Anderson

Elisabeth Haub School of 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 in thinking …

Reclaiming The Right To Food As A Normative Response To The Global Food Crisis, Smita Narula

Elisabeth Haub School of 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 to …

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 what drug …

"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane

Reviews

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 with Mike …

Obama Administration Withholds Funds For Drug War In Mexico Pending Human Rights Reform, Christina Mcmahon

Public Interest Law Reporter

No abstract provided.

Re-Stocking The Shelves: Policies And Programs Growing In Food Deserts, Tess Feldman

Public Interest Law Reporter

No abstract provided.

Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman

Faculty Works

Much like tort reform, the debate over recently enacted legislation on biotech drugs — and particularly regulatory supplements to patent protection — has taken on a significance that dwarfs its impact on prescription drug expenditures. Under the Health Care Reform legislation, Congress enacted two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics (FOBs), which are the analogues of generics for biotech drugs. Second, establishment of a twelve-year “data exclusivity” period in which clinical testing data collected by brand-name innovators cannot be used by producers of FOBs to satisfy FDA testing requirements. …

Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa

Richmond Journal of Law and the Public Interest

Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally strengthen their warning without prior FDA approval under current regulations to head off any state tort claims for failure to warn. If the FDA ultimately determines not to approve the strengthened label, under explicit authority granted by Congress in the FDCA, drug makers have a strong argument that implicit conflict preemption now applies. As another avenue, drug makers may include a potential warning amounting to a prohibition of the drug's use or method of delivery when seeking initial approval of the warning label. Again, …

Wine Wars: How We Have Painted Ourselves Into A Regulatory Corner, Rachel M. Perkins

Vanderbilt Journal of Entertainment & Technology Law

A private citizen can violate the Constitution in two ways. The first is by enslaving another person, an atrocious act that should be proscribed by the highest law in the land. The second is by transporting alcohol across a state line in violation of the laws of that state. The two actions are hardly of the same magnitude.

The history of alcohol regulation has been a litany of failed attempts--on both the state and federal levels. Each new layer of legislation created additional problems. Most are familiar with the infamy of Prohibition, the federal ban on the manufacture or sale …

State Taxation Of Marijuana Distribution And Other Federal Crimes, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The financial crisis has breathed new life into proposals to reform marijuana law. Commentators suggest that legalizing and taxing marijuana could generate substantial revenues for beleaguered state governments-as much as $1.4 billion for California alone. This Article, however, suggests that commentators have grossly underestimated the difficulty of collecting a tax on a drug that remains illegal under federal law. The federal ban on marijuana will impair state tax collections for two reasons. First, by giving marijuana distributors powerful incentives to stay small and operate underground, the federal ban will make it difficult for states to monitor marijuana distribution and, consequently, …

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, 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 …

The Legal Ecology Of Resistance: The Role Of Antibiotic Resistance In Pharmaceutical Innovation, Kevin Outterson

Cardozo Law Review

Antibiotic effectiveness is a common pool resource that can be prematurely depleted through resistance. Some experts warn that we may face a global ecological collapse in antibiotic effectiveness.

Conventional wisdom argues for more intellectual property rights to speed the creation of new antibiotics. Recent theoretical literature suggests that conservation-based approaches may yield superior results. This Article describes a novel typology for organizing these emerging theories and provides an early empirical test of these models using proprietary data on the sales of vancomycin, an important hospital antibiotic for the last three decades.

The results challenge the assumptions in several models and …

Bundling Public And Private Goods: The Market For Sustainable Organics, Margot J. Pollans

Elisabeth Haub School of 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 and …

Allocating Liability For Deficient Warnings On Generic Drugs: A Prescription For Change, Sarah C. Duncan

Vanderbilt Journal of Entertainment & Technology Law

Brand-name pharmaceutical companies create pioneer drugs that cure diseases around the world. However, because research and development costs are very high, brand-name drugs are expensive. In response to escalating costs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act") to promote generic competition. As generics become more prominent in the pharmaceutical marketplace, individuals injured by generic drugs are suing the manufacturers with more frequency. The cases often turn on which company should bear the liability for failing to warn--the brand-name manufacturer or the generic drug maker. Although the injured person took the generic drug, …

Taking From Trailblazers: Learning From Those Who Have Gone Before When Approving Biosimilars, John A. Little, Jr.

Georgia Law Review

The creation of an approval pathway for biosimilar biologicalproducts holds tremendous promise for increased competition in the biopharmaceutical market and financial savings to the health care system. Yet, safely achieving these promised benefits depends heavily on the Food and Drug Administration's ability to evaluate and compare these complicated molecules to previously approved products. Because biosimilars are different than generic drugs, the FDA's current practice of considering only its prior finding of safety and efficacy of a reference product is ill-suited for approval of biosimilars. Unfortunately, the new pathway included in recently enacted health care reform legislation ignores this distinction and …

Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne

The University of New Hampshire Law Review

[Excerpt] “In December 2006, the Food and Drug Administration (FDA) announced that it had reviewed all the available evidence and was poised to approve meat and milk from cloned animals and their progeny. I remember telling one of my colleagues, a patent law professor, who should be as comfortable with technology as anyone, about this development, and his response was, “Yuck. I’m not eating it!” To which of course I replied, “Humph. You won’t know the difference.” Meat or milk from a clone or its descendant is virtually identical to meat or milk from a non-clone, said the FDA, as …

Labeling Of Credence Attributes In Livestock Production: Verifying Attributes Which Are More Than "Meet The Eye", Nicole J. Olynk, Christopher A. Wolf, Glynn T. Tonsor

Journal of Food Law & Policy

Americans are increasingly sensitive to the conditions under which the foods they purchase and consume are produced. It is becoming commonplace for consumers to incorporate perceived environmental impacts, animal welfare concerns, and other process attributes into food purchase decisions. Increased interest in production practices and technologies employed in food production has been seen in the U.S. specifically concerning irradiation, antibiotics, and hormone and pesticide use. Perhaps one of the most controversial technologies employed in food production today is the use of genetic engineering. Not surprisingly, consumers are particularly sensitive about practices employed or technologies used in foods produced specifically for …

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of developments in Canadian food law and policy in 2009. This update primarily analyzes the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm. In 2009, regulatory and policy developments continue to be dominated by the 2008 Listeriosis outbreak in ready-to-eat, deli meats. Other noted activities include Canada's ongoing efforts to minimize the effects of infectious diseases related to meat production, Canada's request for a WTO panel to consider the effects of American Country of Origin Labelling, and an initiative …

Journal Of Food Law & Policy - Fall 2009, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

A Healthy Diet Of Preemption: The Power Of The Fda And The Battle Over Restricting High Fructose Corn Syrup From Food And Beverages Labeled 'Natural', Adam C. Schlosser

Journal of Food Law & Policy

America is unhealthy. America faces an obesity epidemic. The food consumed by Americans is making them fat. Americans, bombarded every single day by negative headlines like these, are becoming more and more health conscious. This newfound commitment to health is reflected in the food and beverages Americans purchase.

Dietary Supplements And Structure-Function Claims: The Dysfunctional Structure Of Current Regulation, Matthew W. Lindsey

Journal of Food Law & Policy

Twenty percent of Americans report using one of the more than thirty thousand dietary supplement products generated by an estimated one thousand manufacturers, contributing to an industry exceeding twenty billion dollars globally. Fueled by increasing public interest in individual health, dietary supplement manufacturers in the United States (U.S.) continue to exploit the weaknesses in the way the Food and Drug Administration (FDA) regulates these products. Dietary supplement manufacturers perpetuate the perceived safety of supplements through the advertisement of structure-function claims, which many consumers mistakenly assume to be the same as FDA-regulated health claims.