Food and Drug Law Commons^™

Tobacco Denormalization, Anti-Healthism, And Health Justice

Marquette Benefits and Social Welfare Law Review

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Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Anon

Washington Journal of Law, Technology & Arts

A transcript of the symposium's proceedings.

Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Robin Jacob

Washington Journal of Law, Technology & Arts

The Future of Innovation in Medicine Conference (“Conference”) proceedings contained in this Symposium Issue are about the problem of incentivizing research into new uses for established medicines. Putting the problem into the wider context of financing pharma research generally gives an important perspective.

The Patent And Non-Patent Incentives For Research And Development Of New Uses Of Known Pharmaceuticals In Japan, Toshiko Takenaka

Washington Journal of Law, Technology & Arts

Japan is one of most innovative drug manufacturer-friendly countries because it revised its patent and drug regulation systems for providing patent and non-patent incentives for new use and treatment R&D based on its pro-patent and pro-medical science policies. This article provides an overview of the pharmaceutical industry and examines patent and non-patent incentives for drug R&D in focusing on incentives for developing new uses of and treatments for known drugs from a comparative law perspective. After discussing the difficulties in establishing infringement and in obtaining injunctions against generic drug manufacturers who infringe new use product patents, the article reviews measure …

Infringement Of Swiss-Type Second Medical Use Patent Claims In Germany—Recent Developments In Case Law, Matthias Zigann

Washington Journal of Law, Technology & Arts

Following recent regional court decisions on the infringement of second medical use patent claims, the German concept of manifest arrangement—previously believed to provide a safe harbor for generic pharmaceutical companies as long as they skinny-labeled their products—may be subject to a new interpretation. The German decisions are part of a Europe wide series of decisions on the same or similar subject matter and prove to be patent owner friendly.

Innovation In Known Drugs—The European Angle, Galit Gonen

Washington Journal of Law, Technology & Arts

Research into new uses for known drugs should be encouraged because the “repurposing” of known drug molecules can be a highly effective route of innovation for pharmaceutical companies. Investment in the development of these products should be rewarded. However, incentives that are designed to reward innovation must be in line with the size and value of the innovation in order to maintain a sustainable balance between incentivizing research and developing and encouraging a competitive market. In the context of encouraging innovation of new uses for known drugs, factors that facilitate access to drug development and innovation should also be considered …

The Impact Of Marijuana Legalization On Youth & The Need For State Legislation On Marijuana-Specific Instruction In K–12 Schools, Amanda Harmon Cooley

Pepperdine Law Review

State legalization of marijuana is a divisive and polarizing issue that has resulted in fragmentation between governments and citizens. Contrary to federal law, voters in many states have approved ballot initiatives legalizing the sale of marijuana to adults for their recreational use. This Article argues that any state that legalizes marijuana has a concomitant duty to amend its K–12 public school instructional statutes to provide for substantial marijuana education. No state has yet enacted such legislation even though current alternative educational methods fail to provide sufficient safeguards. Accordingly, this Article proposes new statutory remedies that could bridge the gap between …

Patents, Hidden Novelty, And Food Safety, Jeanette M. Roorda

Florida Law Review

This Note discusses how federal agency policy results in a lack of access to patent-protected genetically modified organisms (GMOs) for independent food safety testing. The U.S. GMO policy is a combination of biotechnology regulations and biotechnology intellectual property protections. Intellectual property protection for the developers of new organisms has increased as the technology has advanced from manual pollination to genetic modification methods. Initially the only protection available was in the form of trade secrets, but the protection has increased incrementally to now include full utility patent protection. This Note evaluates the interactions between U.S. Patent and Trademark Office (USPTO) GMO …

Conference Of Soviet And American Jurists On The Law Of The Sea And The Protection Of The Marine Environment, Milton Katz, Richard R. Baxter, O. V. Bogdanov, William E. Butler, Thomas M. Franck, Richard Frank, P. P. Gureev, John L. Hargrove, L. A. Ivanaschenko, Y. Kasmin, V. A. Kiselev, B. M. Klimenko, H. G. Knight, O. S. Kolbasov, A. L. Kolodkin, V. M. Koretsky, F. N. Kovalev, V. N. Kudrjavtsev, B. A. Kuvshinnikov, M. I. Lazarev, A. L. Makovsky, Charles W. Maynes, P. A. Moiseev, John N. Moore, A. P. Movchan, T. M. Starzhina, Robert E. Stein, Grigory I. Tunkin, E. T. Usenko, A. F. Vysotsky, A. K. Zhudro

Georgia Journal of International & Comparative Law

Included in the papers for the Conference of Soviet and American Jurists on the Law of the Sea and the Protection of the Marine Environment:

Introduction by Milton Katz and Richard R. Baxter, p. 1

Freedom of Scientific Research in the World Ocean by A.F. Vysotsky, p. 7

The International Law of Scientific Research in the Oceans by Richard R. Baxter, p. 27

Responsibility and Liability for Harm to the Marine Environment by Robert E. Stein, p. 41

Liability for Marine Environment Pollution Damage in Contemporary International Sea Law by A. L. Makovsky, p. 59

Protection of the Marine Environment …

Innovation And Reverse Payments, Ramsi A. Woodcock

Florida State University Law Review

Settlements of patent litigation between branded and generic drug makers that include a promise by the generic maker to stay out of the market, sometimes in exchange for a ‘reverse’ payment, increase the profits of drug makers at the expense of consumers. Some commentators argue that drug makers will invest these profits in innovation, ultimately making consumers better off. Drug market data suggest, however, that the resulting gains to consumers may still be insufficient to offset consumer losses from delayed access to generics. Even when innovation is taken into account, antitrust can most efficiently eliminate the risk of consumer harm …

Eating For The Environment: The Potential Of Dietary Guidelines To Achieve Better Human And Environmental Health Outcomes, Margaret Sova Mccabe

Law Faculty Scholarship

Agriculture and food production contribute significantly to greenhouse gas emissions and environmental pollution. Shifting human dietary patterns has the potential to reduce such environmental harms while also promoting human health. Government policy, in the form of the United States Dietary Guidelines (USDG), recommends what Americans should eat and could play an important role in shifting the food system to one that is more sustainable. However, the USDG are an overlooked aspect of U.S. food policy. While many countries have moved to synthesize environmental goals with dietary guidance, the United States has taken the opposite approach. In 2015, despite recommendations from …

Engaging Health Insurers In The War On Prescription Painkillers, Valarie K. Blake

Scholarly Works

While insurers have both the power and the motivation to curb the practice of harmful opioid prescribing, they may go about it in ways that could be counter-productive to larger public health goals. After all, insurers have historically discriminated against addiction like any other condition that leads to costly healthcare consumption. In the past, insurers have avoided enrolling addicted insureds and have limited rehabilitation services. To address this epidemic, insurers might engage in ways that could harm third parties. For example, to the extent they are permitted, insurers might avoid addicted enrollees altogether, or might limit coverage of addiction treatments …

Fda-Required Tobacco Product Inserts & Onserts – And The First Amendment, Eric N. Lindblom, Micah L. Berman, James F. Thrasher

O'Neill Institute Papers

In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be interpreted …

Shooting Stars And Dancing Fish: A Walk To The World We Want, Tony Oposa

Environmental Law Program Publications @ Haub Law

From the foreword by Durwood Zaelke, President, Institute for Governance & Sustainable Development, Washington, DC.

“Since the beginning of time, human knowledge and culture have been passed down through stories. Short stories, songs, prayers, poems, even paintings can stick in your mind forever. These have always been the most powerful ways we learn and remember.

Tony is not only one of the world’s greatest lawyers, he is also one of the world’s greatest storytellers.

This book, in which he generously shares his experiences, his scars, and most importantly his humanity, is Tony’s gift to generations to come.

But he does …

Citizen Petitions: Long, Late-Filed, And At-Last Denied, Michael A. Carrier, Carl Minniti

American University Law Review

No abstract provided.

Big Pharma Versus Inter Partes Review: Why The Pharmaceutical Industry Should Seek Logical Hatch-Waxman Reform Over Inter Partes Review Exemption, 50 J. Marshall L. Rev. 337 (2017), Francisco Javier Espinosa

UIC Law Review

No abstract provided.

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization …

Farming And Eating, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

This essay argues that the “us versus them” rhetoric that dominates food and agriculture policy today drives a wedge between farmers and food consumers. Together, farmers and food consumers could form a powerful coalition to challenge the true obstacle to sustainable and equitable food production: concentration of market and political power elsewhere along the food chain.

Pueblo Indian Water Rights: Charting The Unknown, Richard W. Hughes

Publications

This article examines the so-far-unsuccessful efforts to judicially define and quantify the water rights appurtenant to the core land holdings of the 19 New Mexico Pueblos, many of whose lands straddle the Rio Grande. It explains that the Tenth Circuit Court of Appeals has squarely held that Pueblo water rights are governed by federal, not state law, and are prior to those of any non-Indian appropriator, but also that the Tenth Circuit acknowledged that it could not say how those rights should be characterized. Part I of the article examines the course of the cases that have sought to achieve …

The Uncharted Waters Of Competition And Innovation In Biological Medicines, Erika Lietzan

Faculty Publications

In 2010, Congress fundamentally changed how federal law encourages the discovery and development of certain new medicines and for the first time authorized less expensive “duplicates” of these medicines to be approved and compete in the marketplace. The medicines at issue are biological medicines, generally made from, or grown in, living systems. Many of the world’s most important and most expensive medicines for serious and life–threatening diseases are biological medicines.

We have a profound interest in understanding and evaluating the impact of this legislation on innovation and competition. Scholars and courts considering this question may be tempted to reason from, …

Muddying The Waters: Catfish Inspection Authority Transitions To The Food Safety And Inspection Service, Michelle Johnson-Weider

Journal of Food Law & Policy

The Food and Drug Administration regulates the safety and labeling of almost all food in the United States other than meat, poultry, and egg products, which fall under USDA’s Food Safety and Inspection Service (FSIS). Effective September 1, 2017, FSIS assumed inspection responsibility for catfish after years of Congressional lobbying by the small domestic catfish industry. This article examines how this unlikely legislative victory was won against free trade advocates representing much larger economic interests.

Mandatory Labeling Of Bioengineered Foods, Andrew Williams

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Weeding Out Social Welfare Organizations And The Public Policy Doctrine, Jake R. Miller

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Avoiding The Chaos Of Maryjane - A Conventional Approach To Intellectual Property Protection Of Marijuana, 17 J. Marshall Rev. Intell. Prop. L. 278 (2017), Kaylee Willis

UIC Review of Intellectual Property Law

Whether you are considering the ever-popular recreational use, or recent medicinal developments, marijuana is a highly discussed controversial substance. With revenue from marijuana into the billions of dollars, it is no wonder it has been trying to reach into the intellectual property arena. This comment specifically looks into the patent arena and the obstacles that come with an attempt to seek, and enforce protection of marijuana-based patent applications. With the USPTO’s plant and utility patent options, there is perhaps more than one way to pass marijuana-based substances as patent-eligible subject matter. The largest obstacle for this type of intellectual property …

Much Ado About The Tpp’S Effect On Pharmaceuticals, Emily Michiko Morris

SMU Science and Technology Law Review

No abstract provided.

Regulating Milk: Women And Cows In France, Mathilde Cohen

Faculty Articles and Papers

Animal milk, most commonly cow’s milk, is one of the most heavily regulated commodities in both France and the United States. With the increasing popularity of breastfeeding and the possibility of pumping, freezing, and storing breast milk, a cottage industry has emerged for people wishing to buy, sell, or donate milk produced by humans. Yet the legal landscape for human milk remains inchoate, prompting public health officials and medical professionals to call for tighter regulation. Animal and human milk are typically viewed as two distinct substances with little in common beyond a name. In contrast, this Article highlights the analogies …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Journal Articles and Book Chapters

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …

Regulatory Obstacles To Harm Reduction: The Case Of Smoking, Jonathan H. Adler

Faculty Publications

The inability of many smokers to quit is a significant public health problem. The demand for a product that can help smokers kick the habit is an entrepreneurial opportunity. In surveys, a majority of smokers express concern for their health and a desire to kick the habit.

Electronic cigarettes (“e-cigarettes” or “e-cigs”) appear to be the most promising smoking alternative to enter the market to date. E-cigarettes have the potential to satisfy smokers’ craving for nicotine in a less dangerous way. The available evidence suggests e-cigarettes expose smokers (and others) to a fraction of the health risks posed by combustible …

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.