Food and Drug Law Commons^™

Religion In The Time Of Measles: Prescriptions For Minimizing The Public Health Threats Associated With Religious Exemptions From Mandatory Vaccinations, Victor Diego Gonzalez

Cardozo Public Law, Policy & Ethics Journal

The note examines the legal and public health tensions surrounding childhood vaccination mandates, emphasizing the balance between individual rights and societal interests. It argues that while states have the authority to compel vaccinations under their police powers, the proliferation of nonmedical exemptions, particularly philosophical ones, undermines herd immunity and public health. The analysis advocates for stricter criteria for religious exemptions and educational measures to address vaccine hesitancy, while cautioning against eliminating religious exemptions entirely to avoid public backlash.

Tobacco Denormalization, Anti-Healthism, And Health Justice

Marquette Benefits and Social Welfare Law Review

None

Engaging Health Insurers In The War On Prescription Painkillers, Valarie K. Blake

Scholarly Works

While insurers have both the power and the motivation to curb the practice of harmful opioid prescribing, they may go about it in ways that could be counter-productive to larger public health goals. After all, insurers have historically discriminated against addiction like any other condition that leads to costly healthcare consumption. In the past, insurers have avoided enrolling addicted insureds and have limited rehabilitation services. To address this epidemic, insurers might engage in ways that could harm third parties. For example, to the extent they are permitted, insurers might avoid addicted enrollees altogether, or might limit coverage of addiction treatments …

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 Gmo/Ge Debate, Joanna K. Sax

Faculty Scholarship

The scientific community and the public sphere are having different debates about the application of genetic engineering to improve our food supply. Many that are deeply steeped in the science view genetically engineered food as a more precise way to accomplish what we have been doing for centuries, which is genetically modifying our food supply. Some members of the public view genetically engineered food with skepticism especially as it relates to health, safety and the environment. A disconnect between the scientific consensus and public perception is not a new phenomenon. This Article attempts to bridge this gap by explaining what …

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 …

What Is The Purpose Of The Orphan Drug Act?, Matthew Herder

Articles, Book Chapters, & Popular Press

The Orphan Drug Act (ODA) [1], first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed. Three decades later, a growing proportion of industry research and development (R&D) [2] and regulatory drug approvals [3] target diseases affecting fewer than 200,000 persons in the United States, the prevalence-based threshold of rare disease under the ODA.

In a new article published in PLOS Medicine, Aaron Kesselheim and colleagues document an embedded trend: within the …

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

The Death Of Private Practice: How The Rising Cost Of Healthcare Is Destroying Physician Autonomy, Oliver Owaid

Brooklyn Journal of Corporate, Financial & Commercial Law

Over the past two decades, the number of physicians in private practice has dropped dramatically. This trend is the result of the financial pressure imposed by the federal government in response to the skyrocketing cost of healthcare. Physicians, frustrated by stagnant reimbursement rates in conjunction with increased administrative costs and overhead, are choosing hospital staff employment in favor of private practice. This trend is to the detriment of the physician, the taxpayers, and, most importantly, the patients. Patients treated in hospital outpatient settings have worse outcomes than those treated in private practice. In addition, hospital procedures cost both the government …

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 …

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Journal Articles and Book Chapters

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …

A Little Less Regulation: Why Federal Pain Management Laws Are Hurting State Efforts To Combat The Opioid Epidemic, Michael Waldrop

Mitchell Hamline Law Review

No abstract provided.

Mending Invisible Wounds: The Efficacy And Legality Of Mdma-Assisted Psychotherapy In United States' Veterans Suffering With Post-Traumatic Stress Disorder, Jonathan Perry

Journal of Law and Health

Though Veteran Affairs has provided crucial life sustaining—and often lifesaving—treatments to returning soldiers, the substantial and ever-increasing rates of veteran suicides, drug addictions, and criminal behavior indicate a need for broader options in treatment. One of the most profound discoveries uncovered through MDMA-assisted psychotherapy research is MDMA’s facilitation of the alleviation of addictive behavior in subjects, and, as a result, an alleviation of addictions in general. Addiction is one of the key symptoms of post-traumatic stress disorder (PTSD) and drug abuse plays a large role in the other afflictions suffered by veterans, namely criminal activity and a high rate of …

The New York Pharmaceutical Cost Transparency Act: How A Narrow View Of The Prescription Drug Pricing Puzzle Renders A Well-Intentioned Bill Irrational, John G. Curran

Brooklyn Law Review

Pricing prescription pharmaceuticals is a complex process that entails the consideration of a multitude of factors, not the least of which is the research and development expenditure exhausted by drug makers to gain FDA approval. While public sentiment has increasingly turned against the pharmaceutical industry due to its perceived greed as manifested in the high cost of its drugs, the intricacies of pricing such unique products is rarely discussed. A recently proposed New York state bill, the Pharmaceutical Cost Transparency Act (the NYPCTA), continues this unfortunate trend, by requiring companies to disclose the R&D costs of newly approved drugs in …

Potholes: Dui Law In The Budding Marijuana Industry, Zack G. Goldberg

Brooklyn Law Review

The rapid legalization of marijuana across the United States has produced a number of novel legal issues. One of the most confounding issues is that presented by the marijuana-impaired driver. In jurisdictions that have legalized the use of marijuana, how high is too high to get behind the wheel? This note assesses the various marijuana DUI laws that states have implemented to combat marijuana-impaired driving. Many of these statutes have followed in the footsteps of the BAC-based standard used to combat drunk driving—using THC measurements to quantify a driver’s level of marijuana-based impairment. Unfortunately, unlike alcohol, the scientific properties of …

Rethinking Body Property, Kara W. Swanson

Florida State University Law Review

Body products, including blood, gametes, and kidneys, are a routine part of contemporary medicine. They are also controversial. There is a strong preference for donated gifts, based on an intuition that gifts are pure, altruistic, and healthy, and that purchased products (commodities) are tainted, exploitative, and dangerous. Law and policy reflect this dichotomy, preventing market exchanges either by declaring body products non-property or banning sales by the supplying body. Yet with growing scarcity leading to injustice in the allocation and harvesting of body products, calls to allow sales have been increasing, motivating proposals to increase supplies by compensating bone marrow …

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.

Newsroom: Horwitz On Marijuana Legalization 7/15/2016, John S. Kiernan, Roger Williams University School Of Law

Life of the Law School (1993- )

No abstract provided.

Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete

Catholic University Law Review

The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …

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

West Virginia Law Review

No abstract provided.

Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price

Law & Economics Working Papers

Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in different patients, and it is hard to provide the right incentives for producers to develop and disclose information that could limit future sales. Regulation partially fills this gap by requiring sellers to conduct clinical trials and report adverse events. But it is inherently problematic to rely on producers to supply negative information about their own products. Healthcare payers, however, can profit from avoiding inappropriate use of costly technologies. Recent technological …

A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort

Articles

Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed …

Immortal Invasive Initiatives? The Need For A Genetic "Right To Be Forgotten", Thomas Hale-Kupiec

Minnesota Journal of Law, Science & Technology

No abstract provided.

Politically Correct Eugenics, Seema Mohapatra

Faculty Scholarship

No abstract provided.

The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan Jr.

Brooklyn Law Review

Foodborne illnesses sicken millions and kill thousands of Americans every year, leading many to conclude that our dysfunctional government food safety system, which still relies heavily on physical inspections of food and facilities, is incapable of protecting us. As a result, many now look to the private market for solutions to our food safety crisis. One private market approach, food safety liability insurance, is gaining popularity. This article examines the benefits and drawbacks to food safety liability insurance and raises doubts about its ability to improve food safety. The market for safe food is plagued by overwhelming information problems that …

The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi

Faculty Publications

The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the harm or the risk …

Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher

Scholarly Works

In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

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 …