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Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii

IP Theory

Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.

The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.

DePaul Journal of Health Care Law

This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …

The Relevance Of Fda Regulation In Medical Device Product Defect Cases, Edward Correia

DePaul Journal of Health Care Law

Medical device product cases typically involve a jury determination whether a product is unreasonably dangerous. If the product has been cleared for marketing by the Food and Drug Administration, it has been through an extensive regulatory process in which the safety of the product is potentially reviewed by experts. Nevertheless, a number of courts have concluded that juries should not hear about FDA regulation in making factual findings regarding liability and damages.

What the FDA concludes about the safety of a product can be extremely relevant to juries in deciding whether to find there was a defective product and whether …

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

Following The Framework: Intentional Genomic Alterations In Animals, Sarah Copper

Journal of Food Law & Policy

Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, …

The Cow Has Left The Barn: Updating Standards Of Identity To Reflect Consumer Understanding Of Plant-Based Foods, Nicholas G. Miller

Journal of Food Law & Policy

Have you ever seen “tofurkey” at the supermarket and thought it was a rare, delicious cousin of the turkey? The animal based food industries, led by milk and meat producers, are claiming that the reasonable consumer might. On the other hand, the plant based food substitutes are appearing on supermarket shelves with increasingly bold names for their products that tap into our familiarity with animal-based foods, using names like “Beyond Meat.” Where do we draw the line on what plant based food can be called? And who should draw that line? This paper examines the debate surrounding the labeling of …

Man's Best Friend? Fda Adopts New Rule In Wake Of Pet Deaths, But Will It Have A Significant Impact On The Pet Food Industry?, Amanda Paige Marcum

Journal of Food Law & Policy

Eight years after the largest pet food recall in U.S. history,' pet owners are still grappling with mysterious pet illnesses and deaths associated with commercial pet food. This comment discusses a number of issues related to the Food Safety Modernization Act ("FSMA") . First, it looks at a brief history of pet food industry regulation. Second, it examines the mystery of pet deaths related to jerky treats made in China. Third, it discusses recent developments in the law in response to those pet deaths. Fourth, it considers the implications of the rule and how it will affect the standards applicable …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

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.

Preempting State Prevention: How Fda Regulation Ensures Access To Abortion Medication, Jared Shea

Mitchell Hamline Law Review

No abstract provided.

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

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

Off-Label Speech, David A. Simon

Emory Law Journal

This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The more evidence that an off-label use is safe and effective, the less restrictive the regulation should be. The less evidence that an off-label use is safe and effective, the more restrictive the regulation should be. Although intuitive, this is not exactly how current regulation of off-label information works. If the FDA approves a drug, the manufacturer can advertise to doctors and patients for the approved indication. Drug manufacturers cannot, however, promote or …

Speech Regulation And Tobacco Harm Reduction, Jonathan Adler, Jacob James Rich

Faculty Publications

Regulation of commercial speech is a major component of federal regulation of tobacco products. Since adoption of federal tobacco legislation, the Food and Drug Administration has asserted regulatory authority over ENDS and other vaping products as “tobacco products,” subjecting them to the same regulatory regime as traditional tobacco products even though such projects appear to pose less of a threat to public health. Such regulation, and the restriction on truthful speech in particular, may be having negative consequences for public health. Barring producers from informing consumers about the relative risks of vaping products and their potential to reduce smoking eliminates …