Food and Drug Law Commons^™

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Regulatory Silence At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Exploring Precision Fda, An Online Platform For Crowdsourcing Genomics, Jordan Paradise

Faculty Publications & Other Works

The U.S. Food and Drug Administration has created an online platform for the next generation sequencing community, enabling users to evaluate biomarker information and share resources. This article examines this online platform and offers several observations about potential legal and regulatory implications.

Current Navigation Points In Drug Diversion Law: Hidden Rocks In Shallow, Murky, Drug-Infested Waters, John J. Mulrooney Ii, Katherine E. Legel

Marquette Law Review

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Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

“Safe Harbor” On The Rocks: Ttb Label Approval For Beer, Wine, And Spirits, And The Uncertain Status Of The “Safe Harbor” Defense, Michael Mercurio

Notre Dame Journal of International & Comparative Law

This Note examines the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB)’s label review process and the judicial split regarding the “safe harbor” doctrine in the context of alcoholic beverage labels. This Note observes that the judicial split is a result of the tension between two conflicting priorities stemming from the TTB’s purpose and identity: on one hand, courts apply Chevron deference to the TTB as a federal agency enforcing federal law, but on the other hand, courts aim to uphold the central purpose of the Federal Alcohol Administration (FAA) Act—protecting consumers from misinformation. Ultimately, this Note, by examining …

Comment: Prison For You. Profit For Me. Systemic Racism Effectively Bars Blacks From Participation In Newly-Legal Marijuana Industry, Elizabeth Danquah-Brobby

University of Baltimore Law Review

Historically, blacks have been prosecuted and convicted across the United States at significantly higher rates when compared to whites for marijuana-related crimes, despite the fact that studies indicate marijuana use by whites and blacks is relatively equal. Further, individuals with lower economic means were dually susceptible to conviction as a result of less vigorous legal representation.

Now, laws have legalized marijuana for medicinal purposes in twenty-six states, along with a small portion of states (seven) legalizing marijuana for recreational use. Yet retroactive ameliorative relief is not widely available to those who were convicted under circumstances that are now legal, and …

Food Date Labels And Hunger In America, Gwen B. Thomson

Concordia Law Review

Millions of Americans go hungry, while 40% of the food in the United States is wasted. Research has shown that 43% of the waste occurs in homes and that consumers are making decisions about purchasing and throwing away food without understanding the meaning of the food date labels. One of the most cost-effective ways to begin to effect a change is to eliminate the myriad of confusing food date labels so that individuals do not throw away good food. In May 2016, the Food Date Labeling Act of 2016 was proposed in both houses of Congress. This bicameral bill was …

Obesity Prevention Policies At The Local Level: Tobacco's Lessons, Paul A. Diller

Maine Law Review

For at least a decade, commentators have speculated that obesity is the next tobacco, a public health scourge that might nonetheless offer a gold mine to ambitious plaintiffs’ lawyers. Successful lawsuits, as in the tobacco context, might spur the food industry to reform its practices so as to help reduce the alarmingly high national obesity rate. The obesity narrative, however, has not played out accordingly to the same script as tobacco. Relatively quick action by most state legislatures immunized the food industry to tort lawsuits seeking obesity-related damages, and the scant judicial opinions on the issue have skeptically assessed plaintiffs’ …

An Examination Of Trans Fat Labeling: Splitting The Third & Ninth Circuit, Jack Gainey

Washington and Lee Journal of Civil Rights and Social Justice

At first glance, consumer claims alleging misleading labeling would seem to find a simple resolution. Under 21 U.S.C. § 343, which governs misbranded food, a food product is misbranded if “its labeling is false or misleading.” However, controversial interpretation of seemingly straightforward statutory language, together with evolving case law, have blurred a once clear picture. Disagreement over the federal preemption of consumer claims regarding trans fat, underscored by a dispute regarding standing, have combined to create a divergence of opinions between courts across the country.

In 2011, the United States District Court for the Northern District of California considered a …

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 …

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 …

Abuse Of The Hatch-Waxman Act: Mylan's Ability To Monopolize Reflects Weaknesses, Kieran Meagher

Brooklyn Journal of Corporate, Financial & Commercial Law

The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, is intended to lower the average price paid by consumers for prescription drugs. The Hatch-Waxman Act attempts to do so by simplifying the application process for generic drug manufacturers, allowing generic drug applications to circumvent the lengthy FDA testing and approval process that brand-name manufacturers must undergo. Though the Hatch-Waxman Act has successfully created a clear path to the market for generic drugs, it contains loopholes that allow brand name and generic companies to engage in practices aimed at maximizing monopoly profits, effectively …

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 …

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.

3d-Printed Food, Jasper L. Tran

Minnesota Journal of Law, Science & Technology

No abstract provided.

Implementation Of The Public Distribution System: An Empirical Analysis Of The Right To Food In An Urban Slum, Dipika Jain, Brian Tronic

Journal of Food Law & Policy

Malnutrition is one of the biggest problems facing India today. Thus, the functioning of the Public Distribution System (PDS) - which provides subsidized food to hundreds of millions of people is critically important. However, while numerous studies have evaluated the performance of the PDS in rural areas, there is a notable lack of research in urban slums, a rapidly growing population. Through interviews with PDS beneficiaries and other stakeholders, the present study examines the PDS in one slum in Delhi and finds numerous problems, including low quality grain, corruption, and the lack of an effective complaint mechanism. Although several states …

Despite What You've Been Sold - Unwrapping The Falsities Surounding Food Labels, Camille Currey

West Virginia Law Review

No abstract provided.

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …

Underbanked: Cooperative Banking As A Potential Solution To The Marijuana-Banking Problem, Patrick A. Tighe

Michigan Law Review

Numerous states have recently legalized recreational marijuana, which has created a burgeoning marijuana industry needing and demanding access to a variety of banking and financial services. Due, however, to the interplay between the federal criminalization of marijuana and federal anti-money laundering laws, U.S. financial institutions cannot handle legally the proceeds from marijuana activity. As a result, most financial institutions are unwilling to flout federal anti-money laundering laws, and so too few marijuana-related businesses can access banking services. This Note argues that the most viable policy option for resolving this “underbanking” problem is a financial cooperative approach such as a cannabis-only …

The Food And Drug Administration Versus The Federal Trade Commission: Reconciling Their Interests In Regulating Homeopathic Products, 49 J. Marshall L. Rev. 1193 (2016), Jordannah Bangi

UIC Law Review

This Comment suggests that the FDA should require homeopathic products to carry a disclaimer label similar to those used on prescription drugs or certain food or food products.

Baptists, Bootleggers & Electronic Cigarettes, Jonathan H. Adler, Roger E. Meiners, Andrew P. Morriss, Bruce Yandle

Faculty Publications

Electronic cigarettes pose a competitive threat to the makers of cigarettes and other tobacco products, as well as to nicotine replacement therapies such as nicotine gum and patches. A common response to such a threat is support for government regulation to suppress competition. Predictably, cigarette manufacturers and other threatened producers, as well as the governments that earn revenue from tobacco taxes, are supporting greater regulation of electronic cigarettes that would replicate the cartel-supporting rules of the Master Settlement Agreement. These efforts are aided by anti-smoking organizations that would like to prevent the growth of demand for electronic cigarettes. This episode …

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

The Minty Taste Of Death: State And Local Options To Regulate Menthol In Tobacco Products, Michael Freiberg

Catholic University Law Review

Explaining why the additive menthol in tobacco products creates major public health risks, this article advocates for restricting the addition of menthol in cigarettes as a way to reduce smoking-related disease and death. Author Michael Freiberg describes how the decision to regulate menthol in tobacco products, on a federal level, was historically delegated by Congress to the discretion of the U.S. FDA, outlines the U.S. FDA’s subsequent failure to regulate menthol, and surveys state and local government efforts to regulate menthol in response to the FDA’s inaction. The article proposes additional actions that these state and local governments could take …

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

Faculty Publications By Year

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Seattle University Law Review

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right. The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Scholarly Publications

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right.1 The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled

Faculty Publications By Year

No abstract provided.

The 2014 Farm Bill: Farm Subsidies And Food Oppression, Andrea Freeman

Seattle University Law Review

The 2014 Farm Bill ushered in some significant and surprising changes. One of these was that it rendered the identity of all the recipients of farm subsidies secret. Representative Larry Combest, who is now a lobbyist for agribusiness, first introduced a secrecy provision into the bill in 2000. The provision, however, only applied to subsidies made in the form of crop insurance. Until 2014, the majority of subsidies were direct payments and the identity of the people who received them was public information. In fact, the Environmental Working Group’s release of the list of recipients led to a series of …