Food and Drug Law Commons^™

Medical Device Dangers: Choosing Ignorance In The Courts And At The Fda, George Horvath

William & Mary Law Review

Medical devices save lives and improve well-being but have caused as many as 83,000 deaths and 1.7 million injuries in a recent decade. Decisions of critical importance—patients’ decisions whether to have a device implanted, doctors’ decisions about which device to use, insurers’ decisions whether to reimburse for those devices—depend on information about risk that is provided by manufacturers. But producing this information is costly. Injured patients, through private lawsuits under state products liability theories, can incentivize device manufacturers to incur these costs and to produce and disclose information about device risk. Unfortunately, courts are making it increasingly unlikely that this …

Ai V. Mqd: Navigating New Regulatory Challenges In The Life Sciences, Hayden W. Smith

William & Mary Law Review

This Note proceeds in four parts. Part I introduces AI as an emerging technology in the life sciences, the FDA’s inherited regulatory regime, and challenges under the MQD [major questions doctrine]. Part II explores how hypervigilant regulation obstructs innovation and exposes agencies to judicial challenges. Part III offers solutions to safely and effectively navigate the major questions landscape within a framework that fosters AI innovation. This Note proposes a solution that conceptually balances growth in the life sciences with the statutory elements required for a safe and effective regulatory scheme.

This abstract has been taken from the author's introduction.

Speech Regulation And Tobacco Harm Reduction, Jonathan H. Adler, Jacob James Rich

Faculty Publications

Part I of this essay describes what is currently understood about the relative health risks of ENDS [electronic nicotine delivery systems] and other vaping products, particularly as compared to combustible cigarettes.

Part II of this essay describes the current regulatory regime governing tobacco products and how this regime has been applied to ENDS and other vaping products.

Part III of this essay explains how the FDA’s regulatory regime hampers the ability of ENDS manufacturers to inform consumers about the relative risks of their products and the potential use of ENDS as smoking cessation aids.

Part IV explains why this regulation …

Which Came First: The Chicken Or The Chick'n? An Fda Amendment Proposal To Reconcile Conflicting Interests In Plant-Based Meat Labeling, Katie Justison

William & Mary Law Review

“The issue is, what is chicken?” As the market for plant-based meats grows, state legislators are left with the question of what the words “chicken” and “burger” mean on food labels. In response to lobbying from the traditional meat industries, states followed suit with the dairy industry and created regulations and restrictions that carve out a meat industry monopoly on meat-related terms. Commercial speech restrictions such as these are guided by the Central Hudson test. Using that test, this Note will argue that while certain state regulations pass constitutional muster, others impose unconstitutional speech restrictions. This Note will draw particularly …

Direct-To-Consumer Advertising Of Prescription Drugs: Constitutionally Protected Speech Or Misinformation?, Matthew Griffin

William & Mary Law Review Online

This Note will argue that the United States can and should regulate direct-to-consumer (DTC) prescription drug advertisements on television more strictly—preferably by proscribing them altogether. In Part I, this Note will discuss the issues of soaring drug prices, disappointing health care outcomes, a glut of misleading drug advertisements affecting the doctor-patient relationship and personal health, and the problem with the current approach to prescription drug advertising. Part I will also discuss the misleading nature of DTC prescription drug advertisements and some examples of the harm they have caused. Additionally, Part I will propose a solution that focuses on limiting the …

Patent Prophylaxis: Expanding Access To Prep Through 28 U.S.C. § 1498, Jonathan A. Bell

William & Mary Law Review

Part I of this Note details the discovery of Truvada for PrEP [pre-exposure prophylaxis] and the ongoing patent infringement litigation brought by HHS [United States Department of Health and Human Services], discusses the patents currently held by CDC and Gilead, and examines the shortcomings of infringement litigation as a means to expand access to the drug. Part II analyzes the mechanism of march-in rights under the Bayh-Dole Act and discusses two previously attempted applications for the HIV-management drug ritonavir to demonstrate why march-in rights will always fail to expand access to life-saving medications or reduce costs to consumers. Part III …

Alternative Solutions For Government Intervention In Climate Crisis Markets: Price Gouging And The Pandemic Egg Market Case Study, S. Byron Frazelle

William & Mary Environmental Law and Policy Review

The cost of a thing is the amount of what I will call life which is required to be exchanged for it, immediately or in the long run.

The incredible, edible egg.

Fires in California, hurricanes along the Gulf, a worldwide pandemic—it is evident that the year 2020 was defined by great crises, most of which were direct results of or exacerbated by climate change. The effects of these crises on broader American society, in particular that of the COVID-19 pandemic, are just beginning to be realized. Nearly every aspect of American life has been impacted by the pandemic and …

"Not For Human Consumption": Prison Food's Absent Regulatory Regime, Amanda Chan, Anna Nathanson

William & Mary Bill of Rights Journal

Prison food is poor quality. The regulations which govern prison food are subpar and unenforceable by prisoners, due in large part to Sandin v. Conner and the Prison Litigation Reform Act. This Article aims to draw attention to the dire food conditions in prisons, explain the lax federal administrative law that permits these conditions, highlight the role of Sandin v. Conner and the Prison Litigation Reform Act in curtailing prisoners’ rights, and criticize the role of the private entity American Correctional Association in enabling mass neglect of prison food. The authors recommend that the Prison Litigation Reform Act be repealed, …

Professional Medical Judgment And Pharmaceutical Marketing: Drawing Legal And Ethical Lines Around Conflict Of Interest, Steven R. Salbu

William & Mary Business Law Review

Pharmaceutical manufacturers develop relationships with healthcare providers for several purposes, including the marketing and sale of their products. Professional associations give guidance to physicians and companies for managing these relationships ethically. Some practices permitted by these associations entail conflicts of interest. This Article explores two of these practices: (i) company funding of external educational seminars, conferences, and continuing medical education; and (ii) company-hosted speaker programs. The conflict of interest concerns raised by the former practice are manageable, and the practice should continue to be permitted subject to appropriate safeguards; however, the conflict of interest concerns raised by the latter practice …

Coronavirus "Cures" And The Courts, Chad G. Marzen, Michael Conklin

William & Mary Business Law Review

The coronavirus pandemic has drastically affected nearly every aspect of American life. Unfortunately, it has also created an opportunity for those willing to exploit vulnerable citizens by selling fake “cures.” This Article analyzes a lawsuit against televangelist Jim Bakker for doing just that. This Article also calls for increased protection for individuals when a global health pandemic and national emergency have been declared. This Article advocates a novel proposal—the enacting of a federal statute making it a felony for an individual to knowingly sell a fraudulent cure for any disease that has been designated a pandemic by the World Health …

Pricing Drugs Fairly, Govind Persad

William & Mary Law Review

Dissatisfaction with drug prices has prompted a flurry of recent legislation and academic research. But while pharmaceutical policy often regards fair pricing as a goal, the concept of fairness itself frequently goes undefined. Legal scholarship—even work ostensibly focused on fairness—has not defined and defended an account of fair pricing. Recent legislative proposals in the House and Senate have similarly avoided a determinate position on fairness. This Article explains and defends an account of what makes a price for a drug fair (identifying fair price with social value), argues for implementing fair pricing through a price ceiling grounded in social value, …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

Non-Transparent Pbm Cash Flows: Balancing Market Forces Under A Reluctant Legislative Regime, John Mcguinness

William & Mary Business Law Review

No abstract provided.

Innovating Federalism In The Life Sciences, Myrisha S. Lewis

Faculty Publications

This Article challenges the view that the US. Food and Drug Administration (FDA) has exclusive Jurisdiction over life sciences innovations. Many current and forthcoming life sciences innovations are "innovative therapies" such as gene editing, gene therapy, and regenerative stem cell treatments, which are actually "hybrids" of state and federal Jurisdiction. Thus, both state and federal Jurisdiction coexist: federal Jurisdiction exists to the extent that these medical innovations use drugs or biologics, but state Jurisdiction exists to the extent that these innovations are procedures regulated by states as the practice of medicine.

This Article argues that the regulation of numerous current …

Makeup Call: How Cosmetic Product Use Affects Women Absent Federal Regulation, Gabrielle Eriquez

William & Mary Journal of Race, Gender, and Social Justice

No abstract provided.

From A Culture Of Food Waste To A Culture Of Food Security: A Comparison Of Food Waste Law And Policy In France And In The United States, Lindsay Bunting Eubanks

William & Mary Environmental Law and Policy Review

Fighting food waste fights hunger. It also cleans the planet. Currently, one third of all the food produced in the world—1.3 billion tons of edible food—goes to waste every year. Each ton of food wasted produces 3.8 tons of the world’s greenhouse gas emissions. In America, wasted food produces over 20% of methane gas emissions annually. Recovering all this wasted food could feed the food insecure, could clean the environment, and could even create new market opportunities within the food industry. If food industry businesses find ways to resell or recover the cost of what they currently throw away, this …

Quitting Cold Turkey?: Federal Preemption Doctrine And State Bans On Fda-Approved Drugs, Thomas A. Costello

William & Mary Bill of Rights Journal

No abstract provided.

Microscopic Allies: Examining And Tackling Legal And Regulatory Barriers To The Development Of Phage Therapy, Jacob Zent

William & Mary Environmental Law and Policy Review

No abstract provided.

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 …

Persistent Threats To Commercial Speech, Jonathan H. Adler

Faculty Publications

The current Supreme Court is very protective of speech, including commercial speech. Threats to commercial speech persist nonetheless. This article briefly examines two: the use of commercial speech restrictions as a form of rent-seeking, and compelled commercial speech. Regulation of commercial speech is sometimes used to protect established corporate interests from competitors who are less able to bear the costs of regulation, with consequences that extend beyond the economic marketplace. In the case of commercial speech, courts have also been unduly deferential to claims of a consumer “right to know” as a basis for mandated labeling and disclosure. Greater and …

Compelled Commercial Speech And The Consumer "Right To Know", Jonathan H. Adler

Faculty Publications

Compelled commercial speech, including mandatory labeling and the disclosure of factually true information, should not be seen as a separate category of speech under the First Amendment. Rather, compelled commercial speech should be understood as a type of commercial speech and be subject to the same level of protection as commercial speech generally. Accordingly, commercial speech compulsions, such as mandatory disclosures and labeling requirements, must be supported by a substantial government interest under the Central Hudson framework. The assertion of a consumer “right to know” does not constitute such an interest and cannot, by itself, justify compelled commercial speech within …

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 …

Drugs For The Indigent: A Proposal To Revise The 340b Drug Pricing Program, Connor J. Baer

William & Mary Law Review

No abstract provided.

The “Legal” Marijuana Industry’S Challenge For Business Entity Law, Luke Scheuer

William & Mary Business Law Review

In recent years, many states have legalized the use and sale of marijuana for medical or even recreational purposes. This has led to the booming growth of a “legal” marijuana industry. Businesses openly growing and selling marijuana products to the consuming public face some unusual legal hurdles. Significantly, although the sale of marijuana may be legal at the state level, it is still illegal under federal law. This Article explores the conflict between state and federal marijuana laws from a business entity law perspective. For example, managers owe a fiduciary duty of good faith to their businesses and equity holders. …

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” …

Food Ordinances: Encouraging Eating Local, Mia Shirley

William & Mary Environmental Law and Policy Review

No abstract provided.

Symposium On Commercial Speech And Public Health, Jonathan H. Adler

Faculty Publications

Does the constitutional protection of commercial speech impair the government's ability to protect and promote public health? Or does the commercial speech doctrine itself enhance consumer education and harness market competition to advance public health? Do First Amendment limitations on regulation of commercial messages unduly retard governmental efforts to safeguard consumers? Or do they properly constrain illiberal paternalism? If the Court has been over-protective of health-related commercial speech, is there a principled place to redraw the line? And how should those governmental agencies entrusted with the power to protect public health and welfare respond to these constitutional constraints?

The editors …

A Reconsideration Of Agricultural Law: A Call For The Law Of Food, Farming, And Sustainability, Susan A. Schneider

William & Mary Environmental Law and Policy Review

American agricultural policy has evolved from its early focus on agricultural development and expansion to its current focus on economic and political support for the agricultural sector. Agricultural law as a discipline has tracked this policy, with agricultural law scholars debating the origins and the validity of the special treatment of agriculture under the law. This article reviews these debates and calls for a reconsideration of agricultural law and policy to address the unique aspects of agricultural production, the fragility of the environment, and the fundamental need for healthy food. Transforming the special law of agriculture to a new more …

Keeping Agriculture Alive In The Shadow Of A Uranium Mine: Potential Effects And Regulatory Solutions For Virginia, Maggy J. Lewis

William & Mary Environmental Law and Policy Review

No abstract provided.

The Right To Access Experimental Drugs: Why The Fda Should Not Deprive The Terminally Ill Of A Chance To Live, Nicholas J. Plionis

William & Mary Bill of Rights Journal

No abstract provided.