Digital Commons Network^™

Does Federal Law Ban Mailing Abortion Drugs? A Textual Analysis Of 18 U.S.C. § 1461, Peter Allevato

Pepperdine Law Review

As the regulation of abortion availability returned to the States, many have grappled with so-called trigger laws: dormant laws that were set to take effect to restrict or ensure access to abortion should constitutional protection be revoked. While the federal government has no true trigger law, it does have long-unenforced laws prohibiting the mailing of “[e]very article or thing designed, adapted, or intended for producing abortion.” 18 U.S.C. § 1461 is an old law, and it has not been enforced for at least fifty years. But the law’s potential effect on the growing practice of mail-distribution of chemical abortion pills …

Artificial Intelligence Regulation, Minimum Viable Products, And Partitive Innovation, Matthew R. Gaske

Emory Law Journal Online

This Essay identifies entrepreneurs’ experimentation with minimum viable products (“MVPs”) as a means for proposed AI-specific regulation to constrain innovation in other markets. To that end, the Essay coins the term “partitive innovation” to describe a business’s perspective when it uses a domain-agnostic, highly generalizable technology to introduce a product to a particular market, thereby eliciting overbroad domain-specific regulations that impair alternative innovative uses of the underlying technology. This process is unfolding with AI, as broadly constructed proposed regulation can restrict innovation in adjacent fields by shifting software MVPs’ mainly ex post regulatory regime to one with recurring duties or …

The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann

Notre Dame Journal on Emerging Technologies

This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …

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.

Artificial Intelligence And Machine Learning In The Diagnosis And Management Of Stroke: A Narrative Review Of United States Food And Drug Administration-Approved Technologies, Anirudha S. Chandrabhatla, Elyse A. Kuo, Jennifer D. Sokolowski, Ryan T. Kellogg, Min Park, Panagiotis Mastorakos

Department of Neurosurgery Faculty Papers

Stroke is an emergency in which delays in treatment can lead to significant loss of neurological function and be fatal. Technologies that increase the speed and accuracy of stroke diagnosis or assist in post-stroke rehabilitation can improve patient outcomes. No resource exists that comprehensively assesses artificial intelligence/machine learning (AI/ML)-enabled technologies indicated for the management of ischemic and hemorrhagic stroke. We queried a United States Food and Drug Administration (FDA) database, along with PubMed and private company websites, to identify the recent literature assessing the clinical performance of FDA-approved AI/ML-enabled technologies. The FDA has approved 22 AI/ML-enabled technologies that triage brain …

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 …

Regulatory Implications Of Inadequately Designed Pimavanserin Drug Trials Published With Risk Of Bias On Expedited Regulatory Approval Processes, Benson Law

Electronic Thesis and Dissertation Repository

The objective of this retrospective critical appraisal study was to determine if the trials submitted to the Food and Drug Administration for the expedited approval of pimavanserin was of sufficient methodological quality to ascertain its safety and efficacy. After the general metrics of the trials were assessed, the Risk of Bias 2 tool and the PRagmatic Explanatory Continuum Indicator Summary tool were employed to evaluate the risk of bias and the design suitability of the trials. This study suggests that the decision to approve pimavanserin for the treatment of Parkinson’s Disease Psychosis failed to meet the threshold of evidence normally …

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 …

Leveraging Technology In Risk Evaluation And Mitigation Strategy Programs, Sondra Davis, Katie Reynolds, Charles Ulrich

HCA Healthcare Journal of Medicine

Medication safety is improved through REMS programs. Multidisciplinary teams and frontline staff are vital in setting up a REMS program and should be included in any discussions surrounding REMS programs. Certain components of the REMS requirements may be replaced with CDS screens. Utilizing technology can help advance patient safety and aid in regulatory compliance.

Statutory Interpretation And Agency Disgorgement Power, Caprice Roberts

St. John's Law Review

(Excerpt)

In recent decades, the Supreme Court has showed enhanced interest in equitable principles and remedies. What began as periodic cases featuring one jurist’s idiosyncratic and sometimes misguided interpretations has manifested a broader, significant trend. A consequential theme emerges across varied cases: a revival in the Court’s emphasis on the jurisprudence of equitable remedies. The Court’s recent and current docket continues this momentum. Scholars are tracking the developments and advocating for a system of equity; focusing on historical constraints and federal equity power; and generating a restitution revival.

What happens when obstacles foreclose claims and threaten to leave parties without …

The Need For Point-Of-Care Testing Of All Illicit Substances, Channie Cretsinger, Jeremy Kourvelas Mph, Jennifer G. Tourville Dnp, Julia Van Zyl Md

SMART Policy Briefs

An estimated 107,477 overdose deaths occurred in the United States within the last year, with about 4,000 of those deaths being Tennesseans. Over 80 percent of these deaths are attributable to opioids such as fentanyl, for which there does not exist tests approved by the Food and Drug Administration (FDA) for point-of-care testing (POCT). POCT is intended to be used near or at the site of the patient and is performed outside of a physical clinical laboratory, usually at the bedside. A classic example of this is a bedside glucose test in the hospital. Tests for fentanyl and other illicit …

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 …

Update – Food & Drug Administration’S Animal Testing Mandate, Andrew N. Rowan

WellBeing News

Following the end of the Second World War, the World Medical Association developed new ethical guidelines regarding research involving human subjects. These guidelines included requirements to obtain informed consent from research subjects but also emphasized the importance of conducting animal research before engaging in human clinical trials and other human research. This principle was included in legislation mandating the FDA to require prior animal research before permitting human trials of new drugs. That mandate was recently eliminated by new US legislation cosponsored by Senators Cory Booker and Rand Paul. The FDA can now encourage non-animal methods and no longer has …

Fda Greenlights Lab-Grown Meat For Human Consumption, John Rose

D.U.Quark

No abstract provided.

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, …

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

The Case Of The Missing Device Patents, Or: Why Device Patents Matter, Erika Lietzan, Kristina M. L. Acri, Evan Weidner

Faculty Publications

A company that earns premarket approval of its medical device is entitled to an extension of one patent claiming the device, to make up for some of the time it spent doing premarket research. Yet, surprisingly, a mere thirteen percent of those eligible for this extension (also known as patent term "restoration") ask for one. In contrast, most drug companies entitled to this same patent extension ask for one.

In this Article, we attribute the imbalance largely to differences between the two regulatory frameworks. In brief, because the FDA classifies and regulates devices based on what they do and how …

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 …

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

Mitchell Hamline Law Review

No abstract provided.

Is There A Fundamental Right To Privacy When An Educational Institution Requires A Student To Disclose Proof Of His Or Her Vaccination Status?, Mary D. Fatscher

Touro Law Review

In 2020, the coronavirus disease (“COVID-19”) dominated the world. Although the public has progressively become more informed about the disease and how to safeguard itself, challenges persist as there is still much unknown. Aside from wearing masks, social distancing, and despite its undetermined consequences, the COVID-19 vaccination has emerged as a primary solution to substantially reducing the incidence and severity of the virus in our country. Many COVID-19 vaccine mandates were initiated once three pharmaceutical and biotechnology companies including Pfizer-BioNTech, Moderna, and Johnson & Johnson received Emergency Use Authorization from the Food and Drug Administration (“FDA”).

The Patient's Voice: Legal Implications Of Patient-Reported Outcome Measures, Sharona Hoffman, Andy Podgurski

Faculty Publications

In recent years, the medical community has paid increasing attention to patients' own assessments of their health status. Even regulatory agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, are now interested in patient self-reports. The legal implications of this shift, however, have received little attention. This Article begins to fill that gap. It introduces to the legal literature a discussion that has been ongoing in the health care field.

Patient-reported outcome measures (PROMs) are reports of patients’ symptoms, treatment outcomes, and health status that are documented directly by patients, typically through electronic …

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.

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 …

Noticing Patents, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Patents take the form of public letters that the U.S. Patent and Trademark Office (USPTO) actively disseminates. Whether these documents sufficiently provide the public with notice of the technologies they describe, as well as the proprietary rights that they assert, has been subject to long-standing debate. Many commentators conclude that patents are often filed too early in the research and development cycle, are deliberately drafted in a vague or obtuse manner, or are simply too numerous. As a result, identifying the relevant patent landscape is not just difficult for technology implementers, but possibly undesirable as a matter of innovation policy. …