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Articles 1 - 8 of 8
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Paper Promises For Drug Innovation, Erika Lietzan
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
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 …
Gender, Race & The Inadequate Regulation Of Cosmetics, Marie C. Boyd
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 …
Serving Up Allergy Labeling: Mitigating Food Allergen Risks In Restaurants, Marie C. Boyd
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 …
Defining The Opioid Epidemic: Congress, Pressure Groups, And Problem Definition, Taleed El-Sabawi
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 …
Food Federalism: States, Local Governments, And The Fight For Food Sovereignty, Sarah B. Schindler
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 …
A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan
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 …
The History And Political Economy Of The Hatch-Waxman Amendments, Erika Lietzan
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 …