Food and Drug Law Commons^™

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 …

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 …

Man Made Organs: Technology Made It Possible But Can The Fda Keep Up?, Amanda Chatman

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

The Cost Of Evidence: Examining The Fda's Treatment Of Critically-Needed Drugs From An Ex Ante Perspective, Julie Dorais J.D., M.P.H.

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Marijuana Localism, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The states have wrested control of marijuana policy from the federal government, but they risk losing some of their newfound power to another player: local governments. Hundreds of local communities are now seeking to establish their own marijuana policies, from legalization to prohibition and a variety of idiosyncratic regulatory schemes in between. These local efforts raise one of the most important and unresolved questions surrounding marijuana law and policy: What authority, if any, should states give local governments to regulate marijuana? This Article provides some guidance on this question. It starts by identifying two competing considerations that help determine whether …

Scouting For Approval: Lessons On Medical Device Regulation In An Era Of Crowdfunding From Scanadu’S “Scout”, Colleen Smith

Student Award Winning Papers

This Article will argue that medical device companies should be able to utilize crowdfunding to raise the necessary capital to develop a product. However, because of the risks medical devices pose, any solution that allows medical device companies to employ crowdfunding should ensure the continuing commitment to consumer safety that is at the core of FDA regulation. This Article uses the Scanadu Scout as an example and a staring point for evaluating the use of crowdfunding in the medical device industry. This Article explains how and why Scanadu broke the law when it moved the Scout, an “adulterated or misbranded” …

Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan

Faculty Publications

On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other …

Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan

Faculty Publications

Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are multiple options available to …

Denaturalizing Transparency In Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current policy initiatives. Transparency is predominantly understood in terms of information disclosure. Requirements to register clinical trials, publish summary results, share clinical trial data, and disclose physician-industry relationships as well as rationales behind regulatory decision making are each predicated upon this idea that imparting information will both inform and deter unwanted behaviours. In this paper, I argue that understanding transparency qua disclosure has clear limitations and suggest transparency can and should serve an additional function - namely, of enabling standard setting through a more participatory, public …

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

Faculty Publications By Year

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …

The Not So "Sweet Surprise": Lawsuits Blaming Big Sugar For Obesity-Related Health Conditions Face An Uphill Battle, Catherine Srithong Wicker

Journal of Law and Health

Because obesity and its associated health problems have been largely attributed to poor self-control, laziness, and various other personal failings, society has been unwilling to assign blame to food manufacturers for their role in contributing to this problem. But, as consumers are becoming more aware of the significantly harmful effect that poor diets can have on a person’s heath, the scales may be tipping in favor of bringing “Big Food” to court. Food manufacturers, however, are not exactly vulnerable. Armed with precedent disputing the causal link between consumption of fast food and adverse health effects, judicially-created barriers to admitting epidemiologic …

Rethinking The Childhood-Adult Divide: Meeting The Mental Health Needs Of Emerging Adults, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

Part I of this article describes ADHD and explores the extent of ADHD medication abuse, especially among young adults. Part II discusses the characteristics of emerging adults, who may be more likely than their older counterparts to make unwise decisions about medications and other life choices.34 While we protect minors by requiring parental consent for their medical treatments, emerging adults are effectively able to obtain any drug on the market if they convince the doctor that they have the requisite diagnosis. Part III explores HIPAA, the medical malpractice standard of care and the challenges associated with a society that is …

The Importance Of The Right To Food For Achieving Global Health, Emilie K. Aguirre

Faculty Scholarship

The Framework Convention on Global Health (FCGH) represents a significant opportunity to realize the right to health globally. However, in order to succeed the FCGH must be carefully considered: it must take a new evidence-based approach that departs meaningfully from past shortcomings in realizing the right to health. Central to this approach is recognizing, formally incorporating, and operationalizing the right to adequate food. This right should be correctly interpreted as a right to a standard of nutritional quality and not as a right to a minimum number of calories. Because nutrition is critical to the achievement and maintenance of good …

Orthodoxy And 'The Other Man's Doxy': Medical Licensing And Medical Freedom In The Gilded Age, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

This is a draft of Chapter Two of my book-in-progress under contract with Oxford University Press titled You Can Choose Your Medicine: Freedom of Therapeutic Choice in American History and Law. This chapter shows how freedom of therapeutic choice remained an influential theme in American policy and thought in the Gilded Age. Despite the almost universal restoration of medical licensing after the Civil War, the new licensing regimes were drafted and enforced in ways that protected the rights of practitioners and patients of nonorthodox schools of medicine. This chapter starts by briefly describing the main alternative medical sects during the …

The Fda And The Rise Of The Empowered Patient, Lewis Grossman

Contributions to Books

No abstract provided.

Why Healthy Behavior Is The Hard Choice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Our society is structured to encourage unhealthy diets and physically inactive lifestyles, which are key risk factors for chronic diseases including diabetes, heart diseases, and cancers. We are bombarded with advertisements for hyperprocessed foods laden with saturated fat, salt, sugar, and refined carbohydrates, “low-fat” foods often contain high amounts of sugar and salt, and parks and recreation spaces are often inaccessible or unsafe.

Four simple ideas - taxes on unhealthy products, product reformulation, improving the informational environment, and increasing healthy food accessibility - could make healthy behaviors the “default” choice for most consumers. First, taxes on unhealthy products, such as …

Sickeningly Sweet: Analysis And Solutions For Adverse Dietary Consequences Of European Agricultural Law, Emilie K. Aguirre

Faculty Scholarship

Sixty-nine percent of adults in the United States, sixty-four percent in the United Kingdom, and over one-third worldwide are overweight or obese. These staggering figures continue to grow, with accompanying emotional, physical, and economic consequences, both for individuals and society as a whole. The role law plays in facilitating this global trend is significant, and yet puzzlingly, little recognized or understood. The current food system is profoundly structurally flawed: it establishes unhealthy dietary behaviors as the default option for consumers. This Article is the first to examine how agricultural law has facilitated these unhealthier diets for the past fifty years, …

African Aids Crisis: Implications From The Rise Of Managed Care In South Africa, J. Christopher Driver

Georgia Journal of International & Comparative Law

No abstract provided.

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

B.Y.O. Heroin: Will Canada Finally Recognize The Fundamental Rights Of Injection Drug Users By Providing Access To Safe Injection Facilities?, Robert Marston

Georgia Journal of International & Comparative Law

No abstract provided.

Beer, Liquor, Or A Little Bit Of Both? Getting To The Bottom Of Properly Classifying Flavored Malt Beverages In The United States And Australia, Bryan A. Schivera

Georgia Journal of International & Comparative Law

No abstract provided.

High Time For Medical Marijuana Or Buzz-Kill?: The Controlled Substances Act And The Sherman Antitrust Act May Cause Florida's Compassionate Medical Cannabis Act To Go Up In Smoke, Thu Pham

Florida A & M University Law Review

Florida is the latest state to jump into the arena of medical marijuana with the passage of SBI030 on June 16, 2014. The law, named The Compassionate Medical Cannabis Act of 2014,' allows low-THC cannabis to be prescribed to patients suffering from cancer or physical medical conditions that chronically produce symptoms of seizures or severe and persistent muscle spasms.

E-Cigarettes, Vaping, And Youth, Lawrence O. Gostin, Aliza Y. Glasner

Georgetown Law Faculty Publications and Other Works

E-cigarettes, a relatively new product, storming the tobacco industry are causing a massive stir among public health advocates. While e-cigarettes have the potential to serve as an effective harm reduction tool for existing smokers, they also may present an equally tempting pathway to first time smoking, particularly among youth. Many fear that e-cigarettes will revive the popular smoking culture that has taken decades to dismantle.

In April 2014, the FDA issued proposed rules to “deem” or extend its authority over tobacco products to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and orally ingested dissolvable tobacco products. …

A Cost-Benefit Analysis Of Sugary Drink Regulation In New York City, Shi-Ling Hsu

Journal of Food Law & Policy

New York City Mayor Bill de Blasio spent much of his time during his successful 2013 campaign positioning himself as the populist candidate, pointedly contrasting himself with the outgoing mayor, billionaire Michael Bloomberg. There is one Bloomberg initiative, however, that de Blasio has committed to carry forward: the city-wide size restriction on sales of "sugary drinks," most commonly, carbonated sodas. On city public health issues such as the sugary drink policy, the populist de Blasio and the billionaire Bloomberg would appear to have much in common. "People are dying every day, this is not a joke," remarked Bloomberg in striking …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

"Natural" Food Labeling: False Advertising And The First Amendment

Marquette Elder's Advisor

No abstract provided.

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Squashing The Superbugs: A Proposed Multifaceted Approach To Combatting Antibiotic-Resistant Bacteria , Lauren Orrico

Journal of Law and Health

Section II of this Note will provide background on the practices of the United States farming system, which fosters the creation of antibiotic-resistant bacteria. This section will also provide background on the detrimental effects that antibiotic resistance has on human health and will briefly describe the legal history of food and drug regulations. After establishing an informational foundation, Part III will elaborate on current laws and describe the legal authority of key players, before pointing out the shortcomings in current animal feed policy and recommending the development of further regulation in this area. Additionally, Part III will propose new legislation …

Who Can Afford It?: The Patient Protection And Affordable Care Act's Failure To Regulate Excessive Cost-Sharing Of Prescription Biologic Drugs , Michael Callam

Journal of Law and Health

This Note will discuss how the PPACA’s abbreviated approval pathway for biological products creates an expedited procedure to bring less expensive biologic drugs to the market, but ultimately fails to make those biologic drugs affordable because of its lack of provisions limiting insurers’ use of excessive cost-sharing requirements. Part II provides an overview of prescription drugs, compares biologics with traditional prescription drugs, and provides a brief legislative history of prescription drug laws. Part III analyzes the impact of the abbreviated approval pathway on biologic drugs’ costs to prescribed patients. It also examines the PPACA’s effects on biologics inclusion into health …

Smoking Out A Compromise: Splitting The Difference Through A Public Policy Approach To Resolving The Graphic Cigarette Warning Label Circuit Split, Amelia B. Larsen

Cleveland State Law Review

The imposition of graphic warning labels is necessary; the tobacco market exploits the lower class by capitalizing on their under-education regarding the negative health consequences of smoking. This injustice can be corrected by providing the most direct and clear communication imaginable to consumers to ensure they are completely informed of the peril they are placing themselves in when they choose to smoke—the graphic warning labels provide this kind of communication. This Note discusses why the FDA’s warning labels meet First Amendment constitutional scrutiny and serve a substantial governmental interest regarding the country’s public health, socioeconomic equality, and economy. Part II …