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.
