Administrative Law Commons^™

The Crazy Maze Of Food Labeling And Food Claims Laws, Patrick Meyer

St. John's Law Review

(Excerpt)

This Article critiques the role of the FDA in providing consumers with accurate and relevant food label information, identifies impediments in the pursuit of its mission, and offers solutions to those impediments.

Part I of this Article traces the history of U.S. food labeling and health claims laws. Current food laws and their regulation have developed over time. The first federal legislation was passed in the early 1900s. The food laws of today have certainly been influenced by past food laws, which were largely a reaction to societal events. A brief summary of the historical development of our nation’s …

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

The Gm Food Debate: An Evaluation Of The Nationalbioengineered Food Disclosure Standard Andrecommendations For The United States Based On Foodjustice, Courtnee Grego

Seattle University Law Review

This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …

Fda Flip-Flops On Antibiotic Hazard, David A. Wirth

David A. Wirth

No abstract provided.

Fda On Food Additives And Salt, David A. Wirth

David A. Wirth

No abstract provided.

Improving Generic Drug Approval At The Fda, Kathleen Craddock

Michigan Journal of Environmental & Administrative Law

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …

Reforming Regenerative Medicine Regulation, Sarah Duranske

Georgia State University Law Review

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …

Fighting For Your Life In America: A Study Of "Right To Try" Laws Throughout The Country, Danielle Delgrosso

St. John's Law Review

(Excerpt)

This Note argues that there should be a federal statute granting terminally ill patients access to experimental drugs, but that the Trickett Wendler Act, as written is not the proper vehicle for change. An ideal congressional “Right to Try” statute should be crafted to make experimental drugs realistically obtainable for terminally ill patients while protecting those patients and their quality of life. The Trickett Wendler Act’s weaknesses prevent it from reaching this objective because it is too deferential to already unclear state Right to Try laws. Part I explores the right to try movement generally, explaining what a “right …

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more …

Marijuana Appellations: The Case For Cannabicultural Designations Of Origin, Ryan Stoa

Ryan B. Stoa

An appellation is a certified designation of origin that may also require that certain quality or stylistic standards be met. Appellations are most commonly associated with the wine industry, but they can be applied to any agricultural product for which the geographic origin carries importance. The MMRSA [California Medical Marijuana Regulation and Safety Act] … may have far-ranging effects on the marijuana industry in the United States. [A provision of the act permits the state Bureau of Medical Marijuana Regulation to ‘establish appellations of origin for marijuana grown in California.’] As the most populous state in the Union and the …

Hb 249 - Controlled Substances And Prescription Drug Monitoring Database, Emily R. Polk, Brandon M. Reed

Georgia State University Law Review

The Act amends Georgia’s controlled-substances statutes to expand medical provider requirements to record prescription drug information in an electronic prescription drug monitoring program database (PDMP). Medical providers are now required to use the PDMP to enter information about their prescription of certain types and quantities of opioids. The purpose of the act is to fight Schedule II opioid abuse throughout the state of Georgia. A medical provider’s failure to report required information is reported to his or her respective state regulatory board for possible reprimand. In addition to mandatory reporting, the Act includes various other provisions related to regulating opioid …

Regulatory Silence At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Exploring Precision Fda, An Online Platform For Crowdsourcing Genomics, Jordan Paradise

Faculty Publications & Other Works

The U.S. Food and Drug Administration has created an online platform for the next generation sequencing community, enabling users to evaluate biomarker information and share resources. This article examines this online platform and offers several observations about potential legal and regulatory implications.

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

The “Deeming Rule”: The Fda’S Destruction Of The Vaping Industry, Lauren H. Greenberg

Brooklyn Law Review

The FDA has recently passed sweeping regulations, which classifies and then regulates electronic cigarettes as “tobacco products” in the same manner as traditional cigarettes. Though the agency reasons that unknowing adults and children may easily turn to e-cigarettes without fully understanding the potential health effects, there is a lack of conclusive evidence in this field to justify such a comprehensive regulatory scheme. Through the far-reaching “Deeming Rule,” e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market. The channels by which the FDA proposes manufacturers and retailers gain permission from …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Administrative Guidance And Genetically Modified Food, Edward L. Rubin, Joanna K. Sax

Faculty Scholarship

One of the most controversial issues in administrative law, the use of guidance, is exemplified by the regulation of one of the most controversial areas in modern society: genetically modified (GM) food. The appropriate use of guidance versus notice and comment rulemaking is a much-debated issue in administrative law. While agency officials generally assert that they are using guidance to express an agency’s thoughts about how to comply with a specific statutory provision or agency rule, the practical consequence is that the regulated party will hesitate to disobey, even if it believes that the guidance goes beyond the requirements of …