Food and Drug Law Commons^™

Petition Power, Erika Lietzan

Faculty Publications

The law cannot be kept secret. We cannot comply with rules that we do not know. Nor can we question their legitimacy, which is both our right and our duty as citizens. And yet, a substantial body of law applied in this country is difficult for anyone but federal agency insiders to piece together. Rather than publishing regulations that lay out standards of conduct for the future, many agencies interpret the law, and articulate and implement new policies, as they go. Those subject to the law they implement are left to piece the rules together by studying whatever information is …

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 …

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

Faculty Publications

Regulation of commercial speech is a major component of federal regulation of tobacco products. Since adoption of federal tobacco legislation, the Food and Drug Administration has asserted regulatory authority over ENDS and other vaping products as “tobacco products,” subjecting them to the same regulatory regime as traditional tobacco products even though such projects appear to pose less of a threat to public health. Such regulation, and the restriction on truthful speech in particular, may be having negative consequences for public health. Barring producers from informing consumers about the relative risks of vaping products and their potential to reduce smoking eliminates …

Burning Questions: Changing Legal Narratives On Cannabis In Indian Country, Robin M. Rotman, Sam J. Carter

Faculty Publications

In the not-so-distant past, thoughts of Cannabis legalization in the United States were radical. In the present day, the narratives around Cannabis are changing. The term “present day” affixes this Article to early 2023, a snapshot in time. To understand the current legal narratives surrounding Cannabis, and what they might become in the future, it is important to examine the history of Cannabis law and policy in United States. This Article begins by discussing Cannabis regulation in the United States, from the rise of federal regulation to the gradual deregulation by states with tacit federal consent. The Article then examines …

Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri

Faculty Publications

For years pharmaceutical policymaking discussions have been revolving around allegations of supposed “evergreening” by pharmaceutical companies, and policymakers have considered a range of significant policy reforms — including to antitrust law and drug regulatory law — to address this purported problem. This paper evaluates empirical data offered to substantiate “evergreening” and explains that these data — though mostly accurate — do not support proposed policy changes.

The “evergreening” claim is that by securing additional patents and FDA-related exclusivities after approval of their new drugs, brand drug companies enjoy a period of exclusivity in the market that is longer than the …

Ministerial Decision On The Trips Agreement (Wto), Ana Santos Rutschman

Faculty Publications

No abstract provided.

A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll

Faculty Publications

Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …

Ignoring Drug Trademarks, Erika Lietzan

Faculty Publications

If you walk into a pharmacy with a prescription for Merck’s ZOCOR, which contains simvastatin, the pharmacist will probably give you a product containing simvastatin made by another company. The pharmacist will dispense a “generic” simvastatin product. State generic substitution laws, passed in the 1970s to help the government save money by switching patients to cheaper generic drugs, either permit or require this substitution. But drug brand names -- such as ZOCOR -- are trademarks. Like other trademarks, they distinguish goods in the market from others, and they signal the source of the goods. These state laws essentially treat the …

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 …

Distorted Drug Patents, Erika Lietzan

Faculty Publications

Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …

Why The Dea & Not The Fda? Revisiting The Regulation Of Potentially Addictive Substances, Taleed El-Sabawi

Faculty Publications

In addressing the opioid overdose crisis, Congress has explicitly questioned its historic reliance on a criminal justice approach to problem drug use and has instead adopted a more health-oriented approach. Despite Congress' rhetoric, the DEA, a criminal justice agency, continues to retain the power to make key decisions on the classification of potentially-addictive substances, thereby affecting their manufacture, distribution, and overall availability. While the DEA is statutorily required to defer to the Food and Drug Administration (“FDA”), a public health agency, at junctions of the decision-making process, the current “split enforcement” scheme laid out in the statutes has not actualized …

Mphaea & Marble Cake: Parity & The Forgotten Frame Of Federalism, Taleed El-Sabawi

Faculty Publications

Federal parity laws, and their state equivalents, have been shown to increase access to substance use disorder (SUD) treatment, by decreasing the cost of SUD treatment borne by the insured, and has resulted in little increase in health plan costs. Despite these improvements, the effects of parity on access to SUD treatment have been lower than expected. Recent reports suggest that states have varied in their enforcement parity, failures which may explain why persons surveyed still report having inadequate insurance coverage for SUD treatment despite the parity legislation. While other articles have offered suggestions for improving parity, most have lumped …

Our Federalism On Drugs, Jonathan Adler

Faculty Publications

Over the past decade, voters and legislatures have moved to legalize the possession of marijuana under state law. Some have limited these reforms to the medicinal use of marijuana, while others have not. Despite these reforms marijuana remains illegal under federal law. Although the Justice Department has not sought to preempt or displace state-level reforms, the federal prohibition casts a long shadow across state-level legalization efforts. This federal-state conflict presents multiple important and challenging policy questions that often get overlooked in policy debates over whether to legalize marijuana for medical or recreational purposes. Yet in a “compound republic” like the …

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 …

Access Before Evidence And The Price Of The Fda's New Drug Authorities, Erika Lietzan

Faculty Publications

Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA's standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States "gold standard" for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …

The Surprising Reach Of Fda Regulation Of Cannabis, Even After Descheduling, Erika Lietzan, Sean M. O'Connor

Faculty Publications

As more states legalize cannabis, the push to "deschedule" it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis - cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA's focus on precise analytical characterization and on individual active and inactive ingredients may be …

The Role Of Pressure Groups And Problem Definition In Crafting Legislative Solutions To The Opioid Crisis, Taleed El-Sabawi

Faculty Publications

Organized interest groups and federal administrative agencies have historically been influential in defining problem drug use during nationwide crisis. As such, the manner in which these pressure groups defined the problem may have influenced or, at least, provided support for legislators’ decisions to shy away from a criminal justice approach and towards acceptance of a more “health-oriented” — one that did not comprehensively address demand factors or demonstrate a commitment to reforming U.S. drug policy to meet international standards of best practice. In an effort to provide a snapshot of what such involvement may look like, this article explores the …

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

Paper Promises For Drug Innovation, Erika Lietzan

Faculty Publications

Innovation does not stop when a new medicine is launched. Development of new uses for already approved drugs, in particular, can make profound contributions to the public health. Whether a new use is suspected during the initial premarket trials, identified through focused research after approval, or discovered serendipitously by physicians treating patients, however, it requires extensive clinical testing before it can be approved by FDA. This testing takes time and money — three to five years on average, and as much as $300 million. This Article considers the incentives that federal law offers to companies to make this investment: patent …

What Motivates Legislators To Act: Problem Definition & The Opioid Epidemic, A Case Study, Taleed El-Sabawi

Faculty Publications

This article explores why federal legislators may have been motivated to treat the current opioid crisis as a health issue, when past drug problems have been treated as a criminal justice issue. Using theories from political science, policy studies and sociology, this article summarizes leading theories of legislative behavior and applies them to the current opioid crisis, in an effort to better understand what motivates legislators to enact legislation to solve pressing social problems in a way that reframes the problem. Part II of this article provides an overview of the Comprehensive Addiction and Recovery Act, its significance, and how …

Defining The Opioid Epidemic: Congress, Pressure Groups, And Problem Definition, Taleed El-Sabawi

Faculty Publications

The passage of the Comprehensive Addiction and Recovery Act of 2016 evidences a shift in federal legislative support from criminal justice oriented legislative alternatives to more health oriented legislative alternatives to addressing the ongoing Opioid Epidemic. Such a shift was preceded by a redefinition of problem drug use in the policy discourse from an issue of deviancy to a health issue. However, the redefinition of problem drug use as a health issue, has been dominated by policy narratives and causal stories that do not define problem drug use in a manner that aligns with a multi-modal public health oriented legislative …

Serving Up Allergy Labeling: Mitigating Food Allergen Risks In Restaurants, Marie C. Boyd

Faculty Publications

Allergens in restaurant food cause many allergic reactions and deaths. Yet no federal, state, or local law adequately protects people from these harms. Although federal law requires the labeling of “major food allergens” in packaged food, there are no allergen labeling requirements for restaurant-type food. In addition, existing food safety requirements for restaurants are inadequate to prevent allergen cross contact.

The existing legal scholarship on food allergens in restaurants is limited. Much of the legal scholarship on labeling in restaurants focuses on menu labeling — the provision of calorie and other nutrition information to combat obesity. The requirements of Section …

A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan

Faculty Publications

This short paper comments on Professor Carrier's new article, Biologics: The New Antitrust Frontier. His article makes a profound initial contribution to a new area of scholarship, based on a large body of prior work considering antitrust issues relating to small molecule drugs. But Professor Carrier’s article, like my own forthcoming piece on innovation and competition in the biologics marketplace, is inherently speculative. We are making our best judgments about the nature of a still emerging marketplace and likely conduct in that marketplace, based on our understandings of a new regulatory framework that is itself still emerging, the broader legal …

Gender, Race & The Inadequate Regulation Of Cosmetics, Marie C. Boyd

Faculty Publications

Scholars and other commentators have identified failures in the regulation of cosmetics-which depends heavily on voluntary industry self- regulation-and called for more stringent regulation of these products. Yet these calls have largely neglected an important dimension of the problem: the current laissez-faire approach to the regulation of cosmetics disproportionally places women, and particularly women who are members of other excluded groups, at risk. This Article examines federal cosmetics law and regulation through a feminist lens. It argues that cosmetics law and regulation have lagged behind that of the other major product categories regulated by the Food and Drug Administration under …

Food Federalism: States, Local Governments, And The Fight For Food Sovereignty, Sarah B. Schindler

Faculty Publications

Recently, a number of states have sought to withdraw or restrain local power. In this Article, which is part of the “Re-Thinking State Relevance” symposium hosted by the Ohio State Law Journal, I write about a state taking the opposite approach, and attempting to affirmatively endow its local governments with additional powers. The state is Maine, and the context is control over local food production and sales. This Article begins by addressing the emergence of the sustainable local foods movement broadly, and reasons for the growth of this movement. It then focuses more pointedly on the food sovereignty movement, considering …

The History And Political Economy Of The Hatch-Waxman Amendments, Erika Lietzan

Faculty Publications

Reform of the Hatch–Waxman generic drug framework is in the air. Scholars, consumer advocacy groups, regulated industry, and policymakers are engaged in heated debate about perceived shortcomings in the scheme, flaws, and unexpected loopholes. Changes in how the U.S. Food and Drug Administration (FDA) implements the law, as well as changes to the law itself, are under serious consideration. These policymaking discussions take place against a backdrop of shared assumptions about the origins and nature of the original Hatch–Waxman legislation — assumptions that this Article claims are wrong. Convention wisdom holds that the Hatch–Waxman legislation was a delicate compromise privately …

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 …

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, …

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 …

Gras-Fed Americans: Sick Of Lax Regulation Of Food Additives, Martha Dragich

Faculty Publications

Americans are “GRAS-fed” because of a “loophole” in the strict regime Congress provided for the regulation of food additives. Additives - and food products containing them - are exempt from this strict regime if they are accorded GRAS (Generally Recognized as Safe) status. The guidelines Congress provided for achieving that status by scientific evidence of safety are no longer observed. Most additives are determined by the producer alone to be GRAS. At the same time, Americans’ consumption of highly processed foods continues to rise, giving rise to long-term health problems that are increasingly tied to diet. The average American’s diet …