To combat the growing threat of antimicrobial resistance, Congress has considered legislation such as the PASTEUR Act that would provide "market entry rewards" of up to $3 billion for each new FDA-approved drug. As policymakers consider such rewards, they should appreciate valuation challenges long known to the intellectual property community but under-acknowledged in health policy circles. For new drugs, these challenges include hidden government costs already expended, foregone opportunities to pursue alternate means of reducing patient morbidity and mortality, and the risk posed by creeping political influence to future value assessments. It will also be important for legislators to consider the disappointing outcomes of similar past laws, such as the GAIN Act.
Imagine ingesting chemicals every day-chemicals that are regulated and monitored by governmental bodies with missions not to protect human health but to encourage the growth of certain industries and the production of certain products. Imagine these chemicals are applied to our foods-staples in a presumably healthy diet including spinach, strawberries, tomatoes, and apples. Imagine these governmental bodies, those with missions that disregard the chemicals' impact on human health, are not only regulating these chemicals based on a cost-benefit analysis and biased research but also are splitting the various responsibilities-a multi-agency process fraught with inconsistencies and ineffectiveness. These chemicals are pesticides, and these governmental bodies are the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). Enter: the Food Safety Administration Act of 2022. While this bill tasks the newly formed Food Safety Administration with protecting public health by assigning the new agency FDA's current task of enforcing pesticide residue tolerances, the bill ultimately fails to account for the regulation of pesticides delegated to EPA, as well as USDA's role in monitoring various food products and its food-safety-centric National Organic Program. Therefore, this Note argues that, in order for the Food Safety Administration Act of 2022 to effectively address the current gaps in food-safety protection, it must address EPA's and USDA's current roles in the pesticide regulation process because, after all, pesticides are intrinsically laced within Americans' everyday diets.
Can the government interpret kosher dietary laws? For over 100 years, the State of New York has tangled with regulating Kashrut, the set of religious laws concerning food production and consumption in Judaism, through regulating the sale of kosher food and imposing reporting and transparency measures on kosher purveyors. Such laws raise challenging constitutional, property law, and public policy questions: Under what circumstances can the government determine what is kosher without transgressing the First Amendment? How should courts and legislatures balance consumer protection with religious freedom? This Article analyzes the constitutionality of laws regulating Kashrut under the Establishment and Free Exercise Clauses of the First Amendment. Through a close analysis of case law, the Article charts the vicissitudes in New York's oversight of kosher food and examines the intersections of government authority, food regulation, and religious freedom.
Medical products continuously evolve in both complexity and sophistication. As the number of products in development-and urgency of patient access-grows, it is stakeholders' collective responsibility to optimize regulatory oversight to enable more robust access to safe and efficacious products; such optimization is integral to the U.S. Food and Drug Administration's (FDA or agency) mission to safeguard public health. As regulatory policy evolves, incorporating the "Least Burdensome" principles as mandated by Congress and developed across the Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) can help achieve this sought-after optimization. Patients waiting for access to new and genericized medical products are not FDA's fault, but neither are they an "Act of God" to be ignored.1 This Paper examines the Least Burdensome principle as a solution to benefit all stakeholders, while maintaining FDA's gold standard of regulatory rigor Americans trust and depend upon for their individual and collective health.
Smoking is the leading cause of preventable death in the United States. Passage of the 2009 Family Smoking Prevention and Tobacco Control Act (TCA) placed regulatory oversight for tobacco products with the Federal Food and Drug (CTP) has not met expectations for significant tobacco harm reduction. A formal review has recommended that FDA establish a five-year Strategic Plan to refocus on the public health goals of the TCA. This Article explores the path of the CTP and interest group involvement and proposes elements for FDA to consider in formulating that plan.
The psychedelic renaissance is here-after decades in darkness, two psychedelicassisted therapies are approaching FDA approval. The therapies combine a high dose of psychedelics with psychotherapy to treat intractable mental illnesses. This modality presents a novel regulatory landscape. Traditionally, FDA regulates drugs while state governments oversee the practice of medicine. Psychedelic-assisted therapy straddles that line; one component (psychedelics) is clearly a drug, while the other (psychotherapy) falls under the practice of medicine. With approval rapidly approaching, it is imperative to delineate which level of government has jurisdiction over each component to promote availability, safety, and efficacy of these treatments.
A food product designation of vegan has always inherently implied a classification of dairy-free; however, the recent agricultural advancement of precision fermentation has changed this. By producing artificial dairy without the use of cows, manufacturers are able to label a product as vegan even though the product is not dairy-free, thereby creating the "vegan loophole." Although a seemingly insignificant technicality, the "vegan loophole" can be fatal for people who suffer from conditions that involve dairy allergies, such as Galactosemia. Consumers, including those who are not impacted by food allergies, have come to rely on the presence, or absence, of the term "vegan" on food packaging as a basis for ingredient label-reading. The advent of manufactured dairy threatens to disrupt ingredient label-reading practices that have been in place for decades. This paper addresses several possible approaches that the U.S. Food and Drug Administration (FDA) could take to close the "vegan loophole."
Advancements in cell culture technologies have made possible the mass production of cell-cultured tonic food. Unlike cell-cultured meat products, regulatory issues arising from the commercialization of engineered tonic food have not been sufficiently addressed in the scholarly literature. Using edible bird's nest produced with cell culture technologies as a case study, we examined relevant pre-market regulations concerning safety assessments and labeling in five selected jurisdictions-the United States, the European Union, China, Singapore, and Hong Kong. Our comparative analysis indicates that a favorable market entry regulatory regime, combined with a post-market product tracing system, constitutes an effective approach towards commercialization of novel tonic foods. We suggest that a tailored regulatory approach should be established towards such novel food that takes into consideration local contexts and mobilizes public support from key stakeholders.
This Article aims to fill a gap in the scholarly literature relating to the federal government's regulation of drug and medical device manufacturers' speech regarding uses of their products that have not been approved by the U.S. Food and Drug Administration (FDA). Academics have noted the conflict between enforcement of the Federal Food, Drug, and Cosmetic Act (FDCA) against individuals and companies engaged in truthful, non-misleading communications about off-label uses, and First and Fifth Amendment prohibitions on ambiguous regulatory standards that govern speech. But there has been no comprehensive analysis of the complex web of policies that FDA has established over decades, purporting to grant "safe harbor" status to certain forms of manufacturer communications about off-label uses of medical products. Such an assessment is necessary because FDA has completed a rulemaking proceeding to amend the regulation defining intended use, a foundational concept that determines both whether a product is subject to regulation as a drug or device and the scope of a manufacturer's FDCA liability for off-label promotion. Under the regulatory amendments, FDA asserts, even accurate scientific speech about off-label uses can be used as evidence of intended use, and therefore can be the basis for enforcement under the FDCA. This Article provides a detailed account of FDA's creation and repeated modification of policies allowing off-label communications. The purpose of this account is to provide a resource that is not otherwise available in legal publications. It is also intended to call attention to the impact of the new definition of intended use on the safe harbors for manufacturers' medical communications and the associated constitutional issues.
Humanitarian Use Devices (HUDs) are medical devices intended to benefit patients in the treatment or diagnosis of rare diseases or conditions. Although HUDs are Class III products normally subject to premarket approval (PMA), medical device manufacturers may apply for a Humanitarian Device Exemption (HDE) that exempts qualified HUDs from the effectiveness requirements of sections 514 and 515 of the Federal Food, Drug, and Cosmetic Act (FDCA) and subjects them to certain profit and use restrictions. This Article traces the historical development of the HDE and discusses its impact in light of that history.
It is estimated that 30-40% of the food supply in the United States goes uneaten. Wasted food means wasted resources and a wasted opportunity to feed those who are food insecure. In 2018, the United States Department of Agriculture, Food and Drug Administration, and Environmental Protection Agency signed the Winning on Reducing Food Waste Initiative to prioritize reducing food waste. This paper argues that, to make meaningful changes under this initiative, FDA and USDA should use their authority to regulate misbranded products to adopt national food date labeling standards.
A recent Third Circuit Court of Appeals decision in United States v. Vepuri has the potential to undermine the legal framework for drug approvals in the United States. Specifically, this decision could shield copycat products from U.S. Food and Drug Administration (FDA) enforcement action and allow them to enter the market without FDA pre-approval. The loophole created by this decision is accompanied by concerns about product quality, patient safety, and other issues that would be flagged in a premarket review.
Tobacco is the leading cause of preventable death, accounting for approximately 480,000 deaths per year in the United States. Nicotine-the identified drug in tobacco-is highly addictive, comparable to cocaine and heroin. Nicotine sustains tobacco use, causing repeated exposure to toxicants and carcinogens. The risk of nicotine addiction depends on the dose of nicotine delivered and how it is delivered.(1) Children and young adults are especially vulnerable to nicotine's addictiveness because their brains are still developing, and they may not fully appreciate the risks of tobacco use and addiction. For these reasons, policy makers have adopted several measures to prevent tobacco use initiation, such as raising the minimum legal sales age for tobacco products, restricting the sale of kid-friendly flavored tobacco products, and raising the prices of tobacco products. While these measures have helped achieve a great deal of success in the fight against the tobacco epidemic, there is more to be done. Because of nicotine's addictiveness, it becomes important to seek more robust measures to ensure that these highly addictive products are removed from the market. One such measure is prohibiting the sale of tobacco products whose nicotine levels exceed specified thresholds. In June 2022, the U.S. Food and Drug Administration (FDA) announced its plans to propose a product standard that would establish maximum nicotine levels in cigarettes and other finished tobacco products. It is uncertain when a concrete regulatory measure will materialize from this announcement. But states need not wait for FDA action-they can use their traditional police power to regulate nicotine levels in cigarettes. This will not only minimize death and disease from tobacco products, but it will also create an evidence base for federal action and political momentum for such regulation across the county. Although reducing the level of nicotine could be considered a tobacco product standard, whose regulation is preserved only for FDA, litigation related to federal preemption of state flavored tobacco laws has shown that states can permissibly restrict the sales of categories of tobacco products, including banning categories of highly addictive tobacco products.
Combustible tobacco products (e.g., cigarettes and cigars) continue to be one of the leading causes of preventable disease, disability, and death in the United States. Despite over a century of understanding the harms of tobacco products, a combination of political, policy, and legal battles delayed federal tobacco product regulation until the passage of the 2009 Family Smoking Prevention and Tobacco Control Act. The Act created a new center within the U.S. Food and Drug Administration (FDA), the Center for Tobacco Products (CTP), responsible for reviewing and granting marketing authorization for tobacco products based upon a novel regulatory standard "Appropriate for the Protection of the Public Health" (the APPH standard). A novel legal standard for federal regulators, the APPH standard has never been interpreted by the judicial branch. CTP has struggled to interpret and apply it, especially as it relates to Electronic Nicotine Delivery Systems (ENDS products or e-cigarettes). In December of 2022, the Reagan-Udall Foundation completed its third-party review of CTP's thirteen-year history and found multiple policy and operational gaps. Specifically, the report criticized CTP for a lack of transparency and timeliness in its approach to harm reduction (that is, promoting the use of tobacco products that are less dangerous than combustibles, such as smokeless tobacco and ENDS products). It repeatedly encouraged CTP to shift from a reactive to proactive state by, inter alia, publishing objective product standards for premarket authorization that would satisfy the statutory definition of "Appropriate for the Protection of the Public Health." This Article is the first to suggest such objective product standards for ENDS products. It does so by a thorough review of both scientific evidence and legal precedent in administrative law. Promulgation of objective product standards for ENDS products would enshrine harm reduction into the Appropriate for the Protection of the Public Health standard underlying tobacco regulation, providing regulatory clarity for advocates, industry, and policymakers.
The Article discusses growth of the nutraceutical industry and social media as well as the risks and rewards when using influencers on Instagram, TikTok, YouTube, and other social media sites to promote nutraceutical products. The Article discusses the U.S. Food and Drug Administration's (FDA's) and the Federal Trade Commission's (FTC's) enforcement priorities on mental health claims in dietary supplements; recent actions against companies for deceptive influencer endorsements and testimonials regarding nutraceuticals; as well as state-level consumer protection claims, including an example from a recent case in Texas.
To ensure that abortion access remains available for many American women in our post-Roe society, it is imperative that lawmakers and regulators protect and improve access to mifepristone, the "abortion pill." Greater access to mifepristone may improve women's health and increase abortion access for marginalized communities. However, contrasting state laws regarding prosecution and prescription of the drug and an overly stringent Risk Evaluation and Mitigation Strategy (REMS) continue to create barriers to access and stifle these potential benefits. This Article outlines proposed solutions to protect and improve medication abortion access and addresses the impending legal battles and attacks against mifepristone.
Courts granted the U.S. Food and Drug Administration (FDA) considerable deference to carry out its mission throughout the twentieth century, recognizing the agency's scientific expertise and public health mission. Recent Supreme Court decisions such as West Virginia v. EPA, however, have eroded this longstanding practice and cast doubt on the future of deference accorded to administrative agencies when they act pursuant to statutory language that is not always clear-cut. To understand the state of judicial deference to FDA, this Article investigates how federal appellate courts have applied the framework set forth in Chevron v. Natural Resources Defense Council in litigation involving FDA actions since 2000.
Generic substitution laws have greatly expanded the market share of generic drugs by allowing seamless substitution of cheaper generic drugs for more expensive pioneer drugs. These are state laws that provide a legal mechanism for a pharmacist to dispense a substitute drug deemed equivalent to the prescribed drug. However, with the proliferation of combination products, significant flaws in these laws have become apparent in recent years. Particularly, their more traditional approach to equivalency determination is inadequate in allowing appropriate substitution for a subset of combination products. A multi-pronged approach at the federal, state, and prescriber level is needed to address these limitations.
