Food and Drug Law Commons^™

Insulin Federalism, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Pandemic Politics, Public Health, And The Fda, Jordan Paradise, Becky Bavlsik

Faculty Publications & Other Works

No abstract provided.

The Search For Answers: Overcoming Chaos And Inconsistency In Addressing The Opiod Crisis, John Kip Cornwell

Mitchell Hamline Law Review

No abstract provided.

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Avoiding The Trips Trap: A Path To Domestic Disclosure Of Clinical Drug Data Consistent With International Norms, Cynthia M. Ho

Faculty Publications & Other Works

No abstract provided.

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

The Fda’S Power Over Non-Therapeutic Uses Of Drugs And Devices, Patricia J. Zettler

Washington and Lee Law Review

Although we often—and rightly—think of the U.S. Food and Drug Administration (FDA) as regulating important therapies for patients, the agency also can regulate non-therapeutic uses of drugs and devices. The Federal Food, Drug, and Cosmetic Act defines drugs and devices as including not only products intended to address disease but also those intended to affect the structure or function of the body, such as cognitive enhancements, wrinkle removers, and recreational drugs. Indeed, if these broad definitions were read literally, many everyday consumer products—such as winter jackets intended to keep wearers’ warm—may be drugs or devices. Accordingly, Congress, courts, and the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Please Consult Your Lawyer Before Taking Sorrell: How The Fda Should Approach Social Media For Prescription Drug Advertising, Steven Valentino

Upper Level Writing Requirement Research Papers

No abstract provided.

Trademark Enforcement And Statutory Incentives, Leah Chan Grinvald

Cardozo Arts & Entertainment Law Journal

The combination of the recent U.S. Supreme Court case, Romag Fasteners v. Fossil Group, Inc., and the diamond anniversary of the Lanham Act provides good grounds to reflect on how trademark enforcement and statutory incentives have evolved through the years. Although enforcement of one's trademarks through the use of the courts can be traced back to England in the 1790s, trademark litigation and other enforcement activities have exploded, in relative terms, since the enactment of the Lanham Act in 1946. Although not subject to an easy empirical correlation, this trend suggests that the statute has had an impact on increasing …

Potus And Pot: Why The President Could Not Legalize Marijuana Through Executive Action, Robert A. Mikos

Vanderbilt Law School Faculty Publications

Could the President legalize marijuana, without waiting for Congress to act? The 2020 Presidential Election showed that this question is far from hypothetical. Seeking to capitalize on frustration with the slow pace of federal legislative reform, several presidential candidates promised they would bypass the logjam in Congress and legalize marijuana through executive action instead.

This Essay warns that such promises are both misguided and dangerous because they ignore statutory and constitutional constraints on the President’s authority to effect legal change. It explains why supporters of marijuana reform should be wary of legalizing the drug through executive action, even if that …

Interstate Commerce In Cannabis, Robert A. Mikos

Vanderbilt Law School Faculty Publications

By the end of 2020, more than thirty states had legalized cannabis containing tetrahydrocannabinol ("THC") for at least some purposes.' Each of these states has authorized firms to produce and sell cannabis within its borders. In 2019, those state-licensed firms did a brisk business, selling more than $13 billion worth of cannabis.

However, none of that $13 billion of cannabis is now being sold (legally) across state lines. Instead, each legalization state now has its own, hermetically sealed local cannabis market, supplied entirely by cannabis cultivated and processed inside the state. For example, the $1.75 billion worth of cannabis that …

A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll

Faculty Publications

Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …

Encouraging Interagency Collaboration: Learning From Covid-19, Rachel Sachs

Scholarship@WashULaw

In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and other agencies all share responsibilities in the development and dissemination of new healthcare technologies. Scholars have previously written about the importance of interagency collaboration both in the healthcare area and more generally, and about strategies for encouraging collaborative efforts to promote various policy goals. Under these accounts, a failure to collaborate between federal agencies may be unfortunate, but it does not typically result in or exacerbate a crisis. In the …

Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina

Scholarship@WashULaw

State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on …

The Rhetorical Transformations And Policy Failures Of Prescription Drug Pricing Reform Under The Trump Administration, Rachel Sachs

Scholarship@WashULaw

Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language to criticize the pharmaceutical industry and its practices but also introduced ambitious reform policies that had previously lacked acceptance among Republican policy makers. President Trump appears to have been successful in developing a new populist form of rhetoric that Republicans can use in support of novel drug pricing reforms such as the ones his administration considered. From a policy perspective, however, the Trump administration failed to implement any of their more ambitious reform ideas. This …

Gangmastering Passata: Multi-Territoriality Of The Food System And The Legal Construction Of Cheap Labor Behind The Globalized Italian Tomato, Dr. Tomaso Ferrando

FIU Law Review

No abstract provided.

The Making Of An Iconic Cheese: Mozzarella Di Bufala Campana D.O.P., Michele Graziadei

FIU Law Review

No abstract provided.

The Dormant Monster: Florida’S Intrastate Marijuana Regulation And Its Susceptibility To Dormant Commerce Clause Challenge, Ivan Feris, Jr.

FIU Law Review

No abstract provided.