Food and Drug Law Commons^™

Protection Of Pharmaceutical Products And The Second Medical Indications In Comparative Legislation And International Conventions, Kameran Hossen Al-Salihi

UAEU Law Journal

During the past decades, many changes have occurred in the legal system of patents, protection of pharmaceutical products and methods of manufacturing pharmaceutical products. The World Trade Organization (WTO) and the European Patent Convention (EPC), in 1977, has extended the protection of pharmaceutical products and the method of their manufacturing. The TRIPS Agreement which came into force in 1995, committed its Members to provide protection to all their pharmaceutical products regardless of the field of technology. Thus, pharmaceutical products and methods of manufacturing are now covered by this International Protection Act as well as by their National Legislations. However, this …

A Review Of Grey Literature Cited By Food Loss Law And Policy Scholarship, Angela Hackstadt

University Libraries Faculty Scholarship

In the United States, state and federal programs, rules, and legislation attempt to address the social, economic, and environmental impacts of food waste. Research on the efficacy of these interventions rely on a variety of grey literature resources. Grey literature is valuable to policy research but may be overlooked because it is not published commercially and is often deemed unauthoritative. This review focuses on the use of grey literature in food waste law and policy scholarship to identify the most used sources and to determine what, if any, archiving strategies authors use. Recommendations for librarians and researchers are discussed.

Professional Medical Judgment And Pharmaceutical Marketing: Drawing Legal And Ethical Lines Around Conflict Of Interest, Steven R. Salbu

William & Mary Business Law Review

Pharmaceutical manufacturers develop relationships with healthcare providers for several purposes, including the marketing and sale of their products. Professional associations give guidance to physicians and companies for managing these relationships ethically. Some practices permitted by these associations entail conflicts of interest. This Article explores two of these practices: (i) company funding of external educational seminars, conferences, and continuing medical education; and (ii) company-hosted speaker programs. The conflict of interest concerns raised by the former practice are manageable, and the practice should continue to be permitted subject to appropriate safeguards; however, the conflict of interest concerns raised by the latter practice …

Coronavirus "Cures" And The Courts, Chad G. Marzen, Michael Conklin

William & Mary Business Law Review

The coronavirus pandemic has drastically affected nearly every aspect of American life. Unfortunately, it has also created an opportunity for those willing to exploit vulnerable citizens by selling fake “cures.” This Article analyzes a lawsuit against televangelist Jim Bakker for doing just that. This Article also calls for increased protection for individuals when a global health pandemic and national emergency have been declared. This Article advocates a novel proposal—the enacting of a federal statute making it a felony for an individual to knowingly sell a fraudulent cure for any disease that has been designated a pandemic by the World Health …

Contractual Responsibility Of The Drug Manufacturer In The Federal Legal System, Sayed Hatem Saif El-Din

UAEU Law Journal

Very bad results and dangerous consequences might be the outcome of a simple mistake in the process of medicine production or manufacturing. This danger aggravates and the problem increasingly complicates in the case that these damages and dangers do not appear but after a period of time that might extend to generations, and that such symptoms were not expected upon production.

In the event that there is no legislation in the UAE law to regulate the responsibility of the producer for his dangerous products, the general rules in the contractual responsibility shall be studied, there appropriateness and sufficiency to provide …

Revolving Doors - We Got It Backwards, Hadar Yoana Jabotinsky Dr.

University of Cincinnati Law Review

The revolving door phenomenon, in which senior public officials transfer from the public service to the private sector after finishing their term as public officials, and vice versa, is widespread. This gives rise to concern of regulatory capture, which happens when the regulators respond to the wishes of strong interest groups, such as the regulated industry, instead of protecting the interests of the general public. The solution is usually found in conflict-of-interest rules which set cooling-off periods for individuals moving from the public to the private sector. This paper proposes that although revolving doors do incur some costs, they also …

Pricing Drugs Fairly, Govind Persad

William & Mary Law Review

Dissatisfaction with drug prices has prompted a flurry of recent legislation and academic research. But while pharmaceutical policy often regards fair pricing as a goal, the concept of fairness itself frequently goes undefined. Legal scholarship—even work ostensibly focused on fairness—has not defined and defended an account of fair pricing. Recent legislative proposals in the House and Senate have similarly avoided a determinate position on fairness. This Article explains and defends an account of what makes a price for a drug fair (identifying fair price with social value), argues for implementing fair pricing through a price ceiling grounded in social value, …

Foods-Related Fraud Crimes In Accordance With Uae Federal Law No. 19 Of 2016 On Combating Commercial Fraud, Dr. Ezzat Mohamed El Omary

UAEU Law Journal

Adulteration of food is one of the vital issues that countries concerned about; that is due to their negative impact recently on consumers’ health. Especially, with the liberalization of markets and the globalization. This alongside with the development of fraud methods increased risks to consumers. Thus, The UAE legislator considered this by issuing the Anti-fraud Federal Law No. 19 of 2016, which considered any commitments against human or animal food as a punishable crime. Criminalization in this regard requires that the criminal needs to be a consumer pre to the commit of the crime; such commitments are specified in the …

Mobile Methadone Clinics: A Necessary Step In Fighting The Opioid Epidemic, Laurel E. Via

University of Richmond Law Review

Part I of this Article will discuss the rise in opioid use disorder, the need for effective treatment, and the utility of methadone maintenance treatment options, as well as the history of the ban on mobile clinics. Part II will discuss the NPRM issued by the DEA on February 26, 2020, and explain the likely impact of the rule. Part III will provide an overview of the NPRM in its current form, explain its likely impact as written and show that mobile clinics are effective treatment options, and then argue that while a great start, the NPRM should be amended …

Brewing Green Beer: Building A Regulatory Scheme Robust To Changes In Brewing Technologies, Daniel Pashang Withers

Texas A&M Law Review

New beer brewing technologies provide brewers with options to produce beer in more eco-friendly, less resource-intensive ways; however, as brewers adopt these technologies, they may find themselves straddling between the regulatory schemes of the Alcohol and Tobacco Tax and Trade Bureau (“TTB”) and the Food and Drug Administration (“FDA”). The two agencies have divided control over beers based on their ingredients, which places some beers under the TTB’s purview as “malted beverages” and others under the FDA’s purview. These distinctions have implications for the regulatory hurdles that brewers must overcome to market their products. Additional regulations that eco-friendly, green beers …

Cle Working Paper No. 3/2021--A Roof Over Our Stomachs: The Right To Housing In Canada And Its Implications For The Right To Food, Tasha Stansbury

Centre for Law and the Environment

In 2019, the Canadian government passed the National Housing Strategy Act, legislating for the first time a human right to housing in Canada. This was largely the result of pressure from housing advocates to align Canada’s legislation with the right to housing embedded in international human rights instruments. Despite similar efforts, food rights advocates have not had the same success in having the right to food recognized in Canadian law. This paper considers the question of whether, and how, food rights advocates can use the process of achieving a legislated right to housing as a model in pursuing the legislation …

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.

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.

The Spirit Is Willing: A Proposal For American Single Malt Whiskey, Raymond Cleaveland

Seattle University Law Review

Over the past twenty-five years, small, independent American distilleries have carved out a new niche in the United States liquor market: craft single malt whiskey. Inspired by the success of single malt Scotch and other single malts, American craft distillers are now fighting for their own shelf behind the bar and in the liquor store aisle. In 2018, a cadre of these distillers petitioned the U.S. Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau to formally recognize a new category of whiskey in the Code of Federal Regulations: American Single Malt Whiskey. For purposes of consumer protection, the Treasury …

The Future Of The Agricultural Industry – Is Blockchain A New Beginning?, Ryan Bisel

Seattle University Law Review

As we advance into a digital era, we begin to depend on technological innovations to rapidly help develop and update processes and methods within different industries. Blockchain technology—popularized by cryptocurrency—is slowly making its debut in the agricultural supply chain. Implementing a blockchain requirement for suppliers would be beneficial because it would allow agricultural suppliers and distributors to track their products in a more efficient manner. However, there are four potential legal issues that are foreseeable: (1) preemption, (2) overlapping regulatory authority, (3) applying current legal rules to new technology, and (4) contracting. This Note will specifically focus on issues of …

American Edibles: How Cannabis Regulatory Policy Rehashes Prohibitionist Fears And What To Do About It, Connor Burns, Jay Wexler

Seattle University Law Review

Why can’t we buy a cannabis muffin with our morning coffee? For much of the past century, the answer was simple: cannabis was illegal. Now, however, with more and more states legalizing cannabis for adult use, the answer is far less clear. Even in those states that have legalized cannabis, the simple action of buying and eating edibles at the same location has somehow remained a pipe dream despite consumer demand. Digging a little deeper, we can see how contemporary alarmism—by rehashing the same prohibitionist rhetoric demonizing cannabis for over eighty years—has once again arisen with a new target: cannabis-infused …

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.

No Ifs, Ands, Or Juuls About It: Why Influencers Must Be Held Accountable, Krystina Dorta

Catholic University Journal of Law and Technology

This article analyzes how the FTC’s Endorsement Guide regulating the advertising of e-cigarette products should be applied to social media influencers. The struggle to regulate e-cigarettes by the FDA and the FTC has led to different advertising methods, which either comply with or neglect the FTC’s Endorsement Guide. This article evaluates the federal government’s reaction to the e-cigarette health crisis, followed by a review of the FTC’s previous actions addressing Endorsement Guide violations, along with the consequences on other companies’ marketing strategies. Finally, this article reviews influencer liability standards for Endorsement Guide violations and develops recommendations to improve those standards.

Vaccination Equity By Design, Olatunde C.A. Johnson, Kristen Underhill

Faculty Scholarship

This Essay examines how states’ initial COVID-19 vaccine-distribution strategies tended to disadvantage populations of color, including Black, Latinx, and Native American communities. These dynamics resonate with “inverse equity” effects of other public-health innovations. We argue for a federal regulatory framework to reduce inequity-forcing effects during initial vaccine rollout.

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 …