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Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore

Journal Articles

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than

Rethinking Innovation At Fda, Rachel Sachs, W. Nicholson Price Ii, Patricia J. Zettler

Scholarship@WashULaw

In several controversial drug approval decisions in recent years, the Food & Drug Administration (FDA) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the agency has come to make many innovation-related judgments as part of …

Not So Juris-Prudent: The Misguided Movement To Abandon Chevron Deference Through The Lens Of Mifepristone And The Attacks On Fda Autonomy, Ella Seltzer

Upper Level Writing Requirement Research Papers

No abstract provided.

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore

Journal Articles

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.

The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …

Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina

Scholarship@WashULaw

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers.

Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications …

Fda As Food System Stewards, Margot J. Pollans, Matthew F. Watson

Elisabeth Haub School of Law Faculty Publications

The Food and Drug Administration (“FDA”) is one of the primary regulators of the U.S. food system, yet it all but ignores the food system's vast environmental footprint. Although the agency is not technically an environmental agency, it could and should view redressing the food system's significant environmental footprint as part of its health and safety mission. In this Article, we review FDA's history of National Environmental Policy Act (“NEPA”) compliance. This history affirms our hypothesis that FDA does not view its own work as environmental. The review, along with assessment of some of FDA's core food programs, reveals that …

Supply And Demand: Navigating Emergency Regulatory Developments In The Fight Against Opioid Use Disorder, Eva Bogdewic

Upper Level Writing Requirement Research Papers

No abstract provided.

Fda In The Time Of Covid-19, Elizabeth Mccuskey

Faculty Scholarship

Over the past century, Congress has made the Food & Drug Administration (FDA) responsible for regulating the safety and efficacy of drugs and devices being deployed in the fight against the COVID-19 pandemic. The FDA’s regulatory infrastructure was built for public health threats and to combat manufacturers' misinformation about treatments.

This article spotlights the ways in which FDA has been adapting to a new challenge during the COVID-19 pandemic: combating misinformation emanating from within the executive branch.

The New Food Safety, Margot J. Pollans, Emily M. Broad Leib

Elisabeth Haub School of Law Faculty Publications

A safe food supply is essential for a healthy society. Our food system is replete with different types of risk, yet food safety is often narrowly understood as encompassing only foodborne illness and other risks related directly to food ingestion. This Article argues for a more comprehensive definition of food safety, one that includes not just acute, ingestion-related risks, but also whole-diet cumulative ingestion risks, and cradle-to-grave risks of food production and disposal. This broader definition, which we call “Food System Safety,” draws under the header of food safety a variety of historically siloed, and under-regulated, food system issues including …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

Tip Of The Iceberg Ii: How The Intended-Uses Principle Produces Medical Knowledge And Protects Liberty, Christopher Robertson

Faculty Scholarship

In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first part of this symposium contribution, we offer a case study of Seroquel XR, showing how the FDA’s premarket approval process – and the restrictions on “off-label” promotion in particular – caused the drug company to produce and disseminate knowledge about safety and efficacy for new uses. The law successfully resolved the collective action problem of producing knowledge, even while the law protected the liberty of individual doctors and patients to use …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Scholarly Publications

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right.1 The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

Agency Publicity In The Internet Era, Nathan Cortez

Faculty Journal Articles and Book Chapters

This Report, prepared for the Administrative Conference of the United States (ACUS), details how federal agencies use modern forms of publicity - including press releases, agency web sites, searchable online databases, and social media - to achieve regulatory ends. It evaluates the benefits and burdens of modern agency publicity practices, using three agencies as case studies: the Food and Drug Administration (FDA); the Federal Trade Commission (FTC); and the Consumer Financial Protection Bureau (CFPB). Part V recommends a series of largely procedural reforms that balance the need for public disclosure with the need to protect those potentially injured by adverse …

Administrating Patent Litigation, Jacob S. Sherkow

Articles & Chapters

Recent patent litigation reform efforts have focused on every branch of govemment-Congress, the President, and the federal courts-save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as "gatekeepers" to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation.

Understanding administrative agencies' functions in managing or directing, i.e., "administrating," patent litigation sheds both descriptive and normative insight on several aspects of patent reform. These include several problems …

Administering Patent Litigation, Jacob S. Sherkow

Articles & Chapters

Recent patent litigation reform efforts have focused on every branch of government — Congress, the President, and the federal courts — save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as “gatekeepers” to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation. Understanding administrative agencies’ functions in managing or directing, i.e., “administrating,” patent litigation sheds both descriptive and normative insight on several aspects of patent reform. …

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Layers Of Law: The Case Of E-Cigarettes, Eric A. Feldman

All Faculty Scholarship

This paper, written for a symposium on "Layers of Law and Social Order," connects the current debate over the regulation of electronic cigarettes with socio-legal scholarship on law, norms, and social control. Although almost every aspect of modern life that is subject to regulation can be seen through the framework ‘layers of law,’ e-cigarettes are distinguished by the rapid emergence of an unusually dense legal and regulatory web. In part, the dense fabric of e-cigarette law and regulation, both within and beyond the US, results from the lack of robust scientific and epidemiological data on the behavioral and health consequences …

Liberty Of Palate, Samuel R. Wiseman

Scholarly Publications

As lawmakers concerned with problems as diverse as childhood obesity, animal cruelty, and listeria have increasingly focused their attention on consumers, legal issues surrounding food choice have recently attracted much broader interest. Bans on large sodas in New York City, fast food chains in South Los Angeles, and foie gras in California and Chicago have provoked national controversy, as have federal raids on raw milk sellers. In response, various groups have decried restrictions on their ability to consume the food products of their choice. A few groups have organized around the principle of what we might call liberty of palate, …

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

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 …

Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused …

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 …

Thoughts On Preemption In The Wake Of The Levine Decision, Erika Lietzan, Sarah E. Pitlyk

Faculty Publications

This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s decision in Wyeth v. Levine. Part I describes the Levine decision. Part II examines the majority’s holding as it relates to impossibility preemption and considers the future of the doctrine in failure-to-warn suits after Levine. We argue that the announced standard for impossibility preemption — the clear evidence standard — should be interpreted reasonably and not in a manner that effectively eviscerates the doctrine. We also describe other instances of impossibility in the food and drug regulatory context that were not presented to the Court. …

Fda Regulatory Compliance Reconsidered, Carl W. Tobias

Law Faculty Publications

Many observers consider the Food and Drug Administration (FDA) vital for the protection of consumer health and safety. One hundred years ago, Congress established the entity that would become the FDA and authorized it to regulate foods and drugs, critical responsibilities that the agency has long discharged carefully. Throughout the past century, the FDA's regulatory power has expanded systematically, albeit gradually, while legislatures and courts in the fifty American jurisdictions broadened liability exposure for manufacturers that sold defective products that injured consumers. Observers have recently criticized the agency for overseeing pharmaceuticals too leniently, even as states increasingly narrowed manufacturers' liability …

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

Nicotine Withdrawal: Assessing The Fda's Effort To Regulate Tobacco Products, Lars Noah, Barbara A. Noah

Faculty Scholarship

At a press conference held on August 23, 1996, just one year after initially revealing his plans, President Clinton announced sweeping federal regulations to combat the underage use of tobacco products. The Food and Drug Administration (FDA) subsequently published a lengthy preamble to accompany the final regulations, detailing the Agency's assessment of the problem and responding to numerous public comments to its notice of proposed rulemaking (NPRM). Characterizing the growing use of tobacco products as a "pediatric disease," FDA Commissioner David Kessler previously had vowed to alter the smoking habits of the newest generation of tobacco users in order to …