Food and Drug Law Commons^™

Hester’S Dubious Roots And Legacy: Open Fields Doctrine Under Scrutiny, Laura K. Donohue

Georgetown Law Faculty Publications and Other Works

For over a century, open fields doctrine has shaped Fourth Amendment law, denying people the right to be secure on their own property. Its application has steadily expanded, with the result that, by some estimates, the Government can now engage in warrantless surveillance of some ninety-six percent of private land and buildings regardless of fences, postings, the distance from public roads or byways, or the use to which the property is put. An originalist approach throws the doctrine into disarray: at the time of the Founding, common law protected the curtilage, which extended to the fields, barns, storehouses, and other …

Revisiting Patent Linkage, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Alfred Engelberg’s article of a quarter-century ago, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, raised a provocative question that retains currency today. The special provisions that Hatch-Waxman established, and Engelberg addressed, have come to be known as patent linkage. Following the principle of linkage, the Food and Drug Administration (FDA) cannot approve generic drugs for marketing if they would infringe a patent.

Hatch-Waxman’s complex patent provisions aspire towards multiple salutary purposes, including encouraging the prompt availability of generic drugs, improving public notice of pharmaceutical patents, and accelerating dispute resolution proceedings. Congress also attempted to ameliorate perceived …

The Origins Of Covid-19 — Why It Matters (And Why It Doesn’T), Lawrence O. Gostin, Gigi K. Gronvall

Georgetown Law Faculty Publications and Other Works

When Health emergencies arise, scientists seek to discover the cause — such as how a pathogen emerged and spread — because this knowledge can enhance our understanding of risks and strategies for prevention, preparedness, and mitigation. Yet well into the fourth year of the Covid-19 pandemic, intense political and scientific debates about its origins continue. The two major hypotheses are a natural zoonotic spillover, most likely occurring at the Huanan Seafood Wholesale Market, and a laboratory leak from the Wuhan Institute of Virology (WIV). It is worth examining the efforts to discover the origins of SARS-CoV-2, the political obstacles, and …

Mandatory Sars-Cov-2 Vaccinations In K-12 Schools, Colleges/Universities, And Businesses, Lawrence O. Gostin, Jana Shaw, Daniel A. Salmon

Georgetown Law Faculty Publications and Other Works

The Centers for Disease Control and Prevention (CDC) recently issued guidance that fully vaccinated individuals can safely remove masks and end social distancing in most indoor settings. Educational facilities and businesses are faced with whether and how to differentiate between vaccinated and unvaccinated individuals, including requiring proof of vaccination. Mandatory vaccination has historically served as a tool to reach and sustain high immunization coverage and to prevent transmission in K-12 schools, colleges/universities, and health care facilities. Vaccine mandates could extend to workers and customers in businesses to ensure safer environments. This Viewpoint examines the epidemiologic, public health, and legal considerations …

Drug Policy Reform In The Americas: A Welcome Challenge To International Law, Alvaro Santos

Georgetown Law Faculty Publications and Other Works

Drug policy in the American hemisphere is in flux. After decades whereby a prohibitionist regime reigned supreme and proposing alternatives was taboo, several countries have begun to reconsider policy, particularly in the case of marijuana. International law has been instrumental in building the legal and institutional regime of prohibition, and it has remained largely impervious to critiques of its disastrous consequences. Indeed, when it comes to drug law and policy, international law has been part of the problem. Nevertheless, countries in the Americas have begun to adopt innovative strategies that also embrace international obligations. In this essay, I examine the …

Regulating Medicines In A Globalized World With Increased Recognition And Reliance Among Regulators: A National Academies Report, Lawrence O. Gostin, Alastair J. Wood, Patricia A. Cuff

Georgetown Law Faculty Publications and Other Works

Research and development of pharmaceuticals are now complex global endeavors, with drug companies operating worldwide using global supply chains. Pharmaceutical companies source their products from many countries, conduct trials in multiple sites, and market essential drugs and vaccines globally. Yet oversight of drug safety and effectiveness is primarily the responsibility of national regulators of variable capacities. National agencies often undertake product reviews without recognizing that similar reviews are occurring elsewhere, sometimes simultaneously. The result is duplication and redundancy, which benefits neither national nor global public health. Supported by the US Food and Drug Administration (FDA), the National Academies of Sciences, …

“Big” Food, Tobacco, And Alcohol: Reducing Industry Influence On Noncommunicable Disease Prevention Laws And Policies, Belinda Reeve, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The food, tobacco and alcohol industries have penetrated markets in low- and middle-income countries (LMICs), with a significant impact on these countries’ burden of noncommunicable diseases (NCDs). Tangcharoensathien and colleagues describe the aggressive marketing of unhealthy food, alcohol and tobacco in LMICs, as well as key tactics used by these industries to resist laws and policies designed to reduce behavioural risk factors for NCDs. This commentary expands on the recommendations made by Tangcharoensathien and colleagues for preventing or managing conflicts of interest and reducing undue industry influence on NCD prevention policies and laws, focusing on the needs of LMICs. A …

Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan

Georgetown Law Faculty Publications and Other Works

Diets high in fats, sugars, and sodium are contributing to alarming levels of obesity, cardiovascular disease, type 2 diabetes, and certain cancers throughout the United States. Sugary drinks, which include beverages that contain added caloric sweeteners such as flavored milks, fruit drinks, sports drinks, and sodas, are the largest source of added sugar in the American diet and an important causative factor for obesity and other diet-related diseases.

City and county governments have emerged as key innovators to promote healthier diets, adopting menu labeling laws to facilitate informed choices and soda taxes, warnings labels, and a soda portion cap to …

Illegal Marijuana Cultivation On Public Lands: Our Federalism On A Very Bad Trip, Hope M. Babcock

Georgetown Law Faculty Publications and Other Works

Fueled by increasing demand for marijuana, illegal cultivation of the drug on public lands is causing massive environmental harm. The federal government lacks the resources to wage what would be a difficult and costly campaign to eradicate these illegal grow sites and instead focuses its limited resources on enforcing the federal marijuana ban. Marijuana decriminalization might allow legally grown marijuana to squeeze out its illegal counterpart, but the political likelihood of decriminalization is low. The key is reducing demand for the illegal drug by changing public buying preferences. However, doing this depends on an available legal alternative. This Article discusses …

Cool Story: Country Of Origin Labeling And The First Amendment, Rebecca Tushnet

Georgetown Law Faculty Publications and Other Works

Country of origin labeling (COOL) requirements have long been part of government regulation of commerce. While one might ordinarily think of mandatory COOL as part of trade policy--or even as a means of encouraging individual citizens to engage in country-specific buying that would be disallowed as protectionism if carried out by their governments -- the most robust legal challenges to mandatory COOL now come from the First Amendment, not from free trade principles. This reliance on free speech claims offers a stark example of the charismatic force of the First Amendment. Objections having little to do with free speech at …

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 …

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. …

Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley

Georgetown Law Faculty Publications and Other Works

Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to …

Undue Process At The Fda, Lisa Heinzerling

Georgetown Law Faculty Publications and Other Works

For over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the FDA …

Pliva V. Mensing And Its Implications, Brian Wolfman, Dena Feldman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court ruling in PLIVA Inc. v. Mensing will immunize generic drug manufacturers facing failure-to-warn claims from state-law liability, and may also have implications for preemption jurisprudence more generally, says attorney Brian Wolfman and co-author Dena Feldman in this BNA Insight. The authors analyze the ruling, and offer their views on the questions that PLIVA raises about the ongoing vitality of the presumption against preemption, the standard for determining ‘‘impossibility’’ preemption, and the propriety of deference to an agency’s views on preemption.

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …

Wyeth V. Levine And Its Implications, Brian Wolfman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.

After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, …

Technology Unbound: Will Funded Libertarianism Dominate The Future?, Steven Goldberg

Georgetown Law Faculty Publications and Other Works

The panel decision in Abigail Alliance, which found a constitutional right to use certain medicines that have not received Food and Drug Administration approval, may not survive further review, but it already stands as an important signpost on the road to further deregulation of the drug market. This trend mirrors the evolution of the in vitro fertilization (IVF) industry which is remarkably unregulated although it raises numerous ethical and consumer protection issues. These developments share an obvious libertarian underpinning, but in both cases it is an odd sort of libertarianism, because proponents of unmediated access to drugs and IVF also …

Cured Meat And Idaho Potatoes: A Comparative Analysis Of European And American Protection And Enforcement Of Geographic Indications Of Foodstuffs, Lilian V. Faulhaber

Georgetown Law Faculty Publications and Other Works

Geographic indications, as defined by the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS Agreement"), are "indications which identify a good as originating in the territory of a member or region or locality in that territory where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin."

While the general concept of protecting geographically-significant products from competition has existed for centuries, the protection provided to geographic indications varies significantly, both between countries and according to the product being protected.

Since the protection of foodstuffs in both Europe and America is a less …

Obesity And The Struggle Within Ourselves, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author argues that we ought to treat our eating, exercise habits, and girth as personal matters, for the most part, but that law can and should make a contribution, as an ally of our longer-term will against our immediate cravings. Law can be our ally in this fashion without command-and-control intrusion into our private lives. Such intrusion is at odds with our core beliefs and unlikely to produce public health success. It is more likely to provoke popular backlash--one reason why some who stand to gain from our unhealthy dining choices try to cast government efforts to inform these …

Federal Regulation Of Tobacco Products And Products That Treat Tobacco Dependence: Are The Playing Fields Level?, Joseph A. Page

Georgetown Law Faculty Publications and Other Works

Company A is thinking about launching a traditional tobacco product, perhaps a cigarette or a smokeless tobacco confection, with a new ingredient, ingredient level, or ingredient mix that in the past has never been sold. Company B contemplates putting on the market an innovative medication, medical device, or dietary supplement intended to help consumers to free themselves from physical dependence on tobacco products. Company C ponders the possibility of introducing a smoking product whose novelty derives from express or implied marketing claims that the product will decrease or perhaps even eliminate physical dependence on tobacco, or reduce other risks associated …

Book Review: The Aspirin Wars: Money, Medicine, And 100 Years Of Rampant Competition, Joseph A. Page

Georgetown Law Faculty Publications and Other Works

The recent identification of a possible link between the long-term use of aspirin and a reduced incidence of colon and rectal cancer has directed renewed attention to a familiar household medication whose origins reach back to antiquity.

Competition from other painkillers had begun to cut deeply into the market once dominated by aspirin-based products when studies indicated the possibilities, first that the regular consumption of aspirin might prevent second heart attacks, and later that it might lower the risk of heart attacks in healthy individuals. If these two discoveries, as well as the new finding about colon and rectal cancers, …