Food and Drug Law Commons^™

Hitting The Trip Wire: When Does A Company Become A "Marijuana Business"?, Lauren A. Newell

Law Faculty Scholarship

Like the alcohol industry was during Prohibition, the marijuana industry is a profitable one. And, as bootlegging was then, selling marijuana in the United States is currently illegal. Despite the number of states that have legalized or decriminalized the sale of marijuana for medical or recreational use under state law, marijuana sales remain illegal as a matter of federal law under the federal Controlled Substances Act of 1970 (“CSA”). Individuals and entities that violate the CSA face substantial criminal and civil liability, including prison time and fines, alongside a host of additional negative consequences arising from business, tax, bankruptcy, and …

Food And Drug Regulation: A Statutory Approach, Adam I. Muchmore

Books

This is the first chapter of a new casebook on food and drug regulation. This book presents food and drug regulation as a statutory subject. It is organized around the structure of the Federal Food, Drug, and Cosmetic Act, and emphasizes guided reading of statutes, regulations, and federal register documents. Cases are presented primarily when they involve major issues of statutory interpretation, are historically significant, or are in one of the areas where case law plays a major role.

The book is designed to work with a Statutory and Regulatory Supplement provided as a PDF. The statutes and regulations in …

Food And Drug Regulation: Statutory And Regulatory Supplement, Adam I. Muchmore

Books

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 comprehensive.

Pediatric Off-Label Use Of Covid-19 Vaccines: Ethical And Legal Considerations, Elizabeth Lanphier, Shannon Fyfe

Scholarly Articles

After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical permissibility of and considerations for pediatric off-label Covid-19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of the blanket prohibition against off-label pediatric Covid-19 vaccination in the VPA, as it blocks clinicians from providing the care they may determine to be clinically and ethically appropriate for their patient. At the same time, our analysis acknowledges that Covid-19 creates population-level ethical considerations that are at times in tension with individual health interests.

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 …

Supply And Demand: Navigating Emergency Regulatory Developments In The Fight Against Opioid Use Disorder, Eva Bogdewic

Upper Level Writing Requirement Research Papers

No abstract provided.

Off-Label Use In The Twenty-First Century: Most Myths And Misconceptions Mitigated, 54 Uic J. Marshall L. Rev. 1 (2021), James Beck

UIC Law Review

No abstract provided.

The Tobacco Control Act’S Pmta And Mrtp Provisions Mean To Protect The Usa From Any New Tobacco Products That Will Not Reduce Health Harms—But Fda Isn’T Cooperating, Eric N. Lindblom

Journal of Health Care Law and Policy

No abstract provided.

Social Justice As A Necessary Guide To Public Health Disaster Response, Stephen S. Hanson

Journal of Health Care Law and Policy

No abstract provided.

Food Justice For All: Tailoring Urban Agriculture Law To Aid Disadvantaged Communities, Seth Stevens

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

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.

Kentucky’S Hunger Crisis: A Preventable & Overlooked Tragedy, Ryan Quarles

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Hemp's Arbitrary 0.3% Thc Legal Standard And The Consequences Of Applying Such Standard, Michelle Bodian, Shawn Hauser

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The Impossibility Defence: Supreme Court Case Summary: Han Fang Guan V Public Prosecutor, Kwang Chian Lee

Singapore Law Journal (Lexicon)

In Han Fang Guan v Public Prosecutor [2020] SGCA 11, the Court of Appeal (“CA”) clarified the law regarding “impossible attempts”, which are attempts to commit an offence that could not possibly have been consummated in the circumstances. The accused Han Fang Guan (“Han”) was charged with the capital charge of attempting to possess one bundle containing not less than 18.62g of diamorphine (also known as heroin) for the purpose of drug trafficking, an offence under section 5(1)(a) read with section 5(2) and section 12 of the Misuse of Drugs Act (Cap 185, 2008 Rev Ed) (“MDA”).

Ignoring Drug Trademarks, Erika Lietzan

Faculty Publications

If you walk into a pharmacy with a prescription for Merck’s ZOCOR, which contains simvastatin, the pharmacist will probably give you a product containing simvastatin made by another company. The pharmacist will dispense a “generic” simvastatin product. State generic substitution laws, passed in the 1970s to help the government save money by switching patients to cheaper generic drugs, either permit or require this substitution. But drug brand names -- such as ZOCOR -- are trademarks. Like other trademarks, they distinguish goods in the market from others, and they signal the source of the goods. These state laws essentially treat the …

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …

Tobacco Reborn: The Rise Of E-Cigarettes And Regulatory Approaches, Daniel G. Aaron

Lewis & Clark Law Review

This Article examines e-cigarettes, FDA-regulated products which heat nicotine-containing fluid into an aerosol to be breathed into the lungs. Recent data show that e-cigarettes are used by about one-fifth of U.S. high school students. Given that we have, in the Surgeon General’s words, reached an epidemic of youth e-cigarette use, it is worth asking how a product within FDA jurisdiction became a serious threat to 3.6 million youth.

This Article reviews the law surrounding e-cigarettes and the history of FDA’s attempts to regulate them. Administrative law doctrines instruct us that increased presidential control will rein in misbehaving agencies by allowing …

The Effects Of Police Officer Ideology On Opinions Of Marijuana Legalization, Decriminalization, And Medical Marijuana, Erin Alpandinar

Honors Capstones

No abstract provided.

Contract Law In The Agri-Food Supply Chain, Bianca Gardella Tedeschi

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.

Putting Paper To Pen: Generation Juul's Case For Harm Reduction, Liz Emanuel

Indiana Law Journal

Part I of this Note soberly explores and delineates the perceived and real threats of vaping for America’s youth, concluding with an analysis of the socioeconomic and developmental health effects of nicotine addiction. Part II delves into the federal government’s response to e-cigarettes as well as the powers and limitations of federal regulation under the Food and Drug Administration’s (FDA) “Deeming Rule” and the potential effectiveness of an increase in the national tobacco purchase age or a federal ban on flavored vaping products. Part III discusses the realistic benefits of taking a harm reduction approach to youth vaping in the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents and Special Thanks.

Neither “Post-War” Nor Post-Pregnancy Paranoia: How America’S War On Drugs Continues To Perpetuate Disparate Incarceration Outcomes For Pregnant, Substance-Involved Offenders, Becca S. Zimmerman

Pitzer Senior Theses

This thesis investigates the unique interactions between pregnancy, substance involvement, and race as they relate to the War on Drugs and the hyper-incarceration of women. Using ordinary least square regression analyses and data from the Bureau of Justice Statistics’ 2016 Survey of Prison Inmates, I examine if (and how) pregnancy status, drug use, race, and their interactions influence two length of incarceration outcomes: sentence length and amount of time spent in jail between arrest and imprisonment. The results collectively indicate that pregnancy decreases length of incarceration outcomes for those offenders who are not substance-involved but not evenhandedly -- benefitting white …

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, …