Food and Drug Law Commons^™

Narratives Of Quality In European Food Governance And Beyond, Lorenzo Bairati

FIU Law Review

No abstract provided.

Credit Supports For Italian Specialty Products: The Case Of Prosciutto And Long-Aged Cheese, Jorge L. Esquirol

FIU Law Review

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 …

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 …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

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.

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.

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Articles, Book Chapters, & Popular Press

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham

Articles, Book Chapters, & Popular Press

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. …

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

In The Name Of Public Health: Misoprostol And The New Criminalization Of Abortion In Brazil, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the …

Securing Safe Supply During Covid-19 And Beyond: Scoping Review And Knowledge Mobilization, Matthew Bonn, Natasha Touesnard, Brianna Cheng, Michael Pugliese, Emilie Comeau, Claire Bodkin, Thomas D. Brothers, Leah Genge, Matthew Herder, Candis Lepage, Ayden Scheim, Dan Werb, Sheila Wildeman

Articles, Book Chapters, & Popular Press

Background

Safe supply is defined as the legal and regulated provision of drugs with mind and/or body altering properties that have been typically accessible only through the illegal drug market. In response to the coronavirus disease 2019 (COVID-19) pandemic and related social/physical distancing measures, efforts have been made to scale up and increase access to safe supply programs in an effort to reduce overdose and other drug- and drug policy-related risks. However, it remains unclear whether these efforts taken thus far have meaningfully mitigated the barriers to safe supply experienced by People Who Use Drugs (PWUD), both during and beyond …

Drugs, Patents, And Well-Being, Christopher Buccafusco, Jonathan S. Masur

Faculty Scholarship

The ultimate end of patent law should be to spur innovations that improve human welfare-innovations that make people better off. But firms will only invest resources in developing patentable inventions that will allow them to make money-that is, inventions that people will want to use and buy. This can gravely distort the types of incentives that firms face and the types of inventions they pursue. Nowhere is this truer than in the pharmaceutical field There is by now substantial evidence that treatments for diseases that primarily afflict poorer people-including the citizens of developing nations-are dramatically underproduced, compared with drugs that …

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 …