Food and Drug Law Commons^™

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder

Articles, Book Chapters, & Popular Press

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …

The Burden On Society From Eleventh-Hour "Citizen Petitions" Filed To Slow Generic Drugs, Feldman Robin

Maryland Law Review Online

No abstract provided.

Cannabis Legalization In State Legislatures: Public Health Opportunity And Risk, Daniel G. Orenstein, Stanton A. Glantz

Marquette Law Review

Cannabis is widely used in the United States and internationally despite its illicit status, but that illicit status is changing. In the United States, thirty-three states and the District of Columbia have legalized medical cannabis, and eleven states and D.C. have legalized adult use cannabis. A majority of state medical cannabis laws and all but two state adult use laws are the result of citizen ballot initiatives, but state legislatures are beginning to seriously consider adult use legislation. From a public health perspective, cannabis legalization presents a mix of potential risks and benefits, but a legislative approach offers an opportunity …

Ensuring Access To Emerging Covid-19 Treatments Through Medicare Reimbursement Policy, Rachel Sachs, Adam Sacarny

Scholarship@WashULaw

Effective pharmaceutical treatments for coronavirus disease 2019 (COVID-19) are urgently needed, and there has been an explosion of research into compounds with potential efficacy against the disease. The highest-profile success to date is Gilead Sciences’ antiviral remdesivir, which received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) after preliminary data showed that it may speed patients’ time to recovery.¹ Gilead is just beginning to sell remdesivir commercially. However, Medicare reimbursement policy is likely to pose challenges for hospitals seeking to administer remdesivir and other COVID-19 drugs to patients. Policy makers ought to think critically …

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …

Accountability, Secrecy, And Innovation In Ai-Enabled Clinical Decision Software, Arti K. Rai, Isha Sharma, Christina Silcox

Faculty Scholarship

This article employs analytical and empirical tools to dissect the complex relationship between secrecy, accountability, and innovation incentives in clinical decision software enabled by machine learning (ML-CD). Although secrecy can provide incentives for innovation, it can also diminish the ability of third parties to adjudicate risk and benefit responsibly. Our first aim is descriptive. We address how the interrelated regimes of intellectual property law, Food and Drug Administration (FDA) regulation, and tort liability are currently shaping information flow and innovation incentives. We find that developers regard secrecy over training data and details of the trained model as central to competitive …

Taming America's Sugar Rush: A Traffic-Light Label Approach, Alexia Brunet Marks

Publications

Excess added sugar negatively impacts health and can lead to a litany of problems, such as diet-related chronic diseases, e.g., diabetes, cancer, heart disease, and obesity, costing Americans millions in rising medical bills each year. Even more, new studies reveal that individuals with these underlying chronic diseases are at a higher risk of complications from COVID-19 and other viruses compared to those who are deemed healthy. And yet added sugars are difficult to avoid because unlike naturally occurring sugars found in fruits, vegetables, and milk, these sweeteners are added during food processing and preparation.

The problem is that while consumers …

Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli

Faculty Scholarship

In this article, I propose that geographical indications (GIs) carry important economic benefits. First, GIs are essential instruments to facilitate investments in high-quality products and niche markets, and promote local trade and development. Second, GIs offer an additional layer of information for consumers about the geographical origin and quality of the products they identify, in turn reducing the information asymmetries between producers and consumers. Third, because of this information function, GIs can assist in rewarding or holding producers accountable for their products based on the additional information they convey to the market. Yet, GIs can also protect culture-related interests and …

Pharmaceutical Drug Pricing: The Internet As A Solution For This Health Issue Turned Financial Issue, Thomas P. Kelly

Brooklyn Journal of Corporate, Financial & Commercial Law

Over the course of five decades, American annual expenditure on pharmaceutical drugs has increased by more than $350 billion. This drastic increase has led many patients to struggle to afford their necessary, and potentially life-saving, medications. Today’s high pharmaceutical prices are largely due to the fact that name-brand drug manufacturers have few restrictions on how much they can charge for their products. Additionally, name-brand manufacturers are able to monopolize the manufacture of their drugs because patent laws prevent other manufacturers from using the formula of these drugs for two decades. To combat these high prices, this Note proposes a partnership …

Global Implementation Of Soda Taxes: Is There A Better Solution For Combatting Obesity?, Lauren Cedeno

Brooklyn Journal of International Law

As incidences of overweight and obese populations continue to increase around the world, countries are looking for ways to decrease the prevalence of this epidemic. Soda and SSB taxes have increased in prevalence as countries seek to address the health problems associated with consumption of soda and other sugary beverages. This Note explores the implementation of these taxes in Mexico, Europe, and the United States. In analyzing these taxes, this Note seeks to gain a greater understanding of whether these taxes have impacted overweight and obesity rates in the countries and municipalities that have enacted them. This Note argues that …

A New Age Of Evolution: Protecting The Consumer’S Moral And Legal Right To Know Through The Clear And Transparent Labeling Of All Genetically Modified Foods, Halie M. Evans

Journal of Law and Health

The United States government, until recently, did not require the labeling of genetically modified organisms (GMOs). On July 29, 2016, President Barack Obama signed into law the National Bioengineered Food Disclosure Standard (NBFDS). This law directs the United States Department of Agriculture (USDA) to create regulations that require manufacturers to disclose certain bioengineered products on food labels. On December 20, 2018, the USDA released the final regulations for the NBFDS, which requires food manufactures, importers, and certain retailers to ensure bioengineered foods are appropriately disclosed. The final regulations include provisions that will leave the majority of GMO derived foods unlabeled. …

Time For Change: Stepping Up The Fda's Regulation Of Dietary Supplements To Promote Consumer Safety And Awareness, George Kennett

Journal of Law and Health

People are often looking for that quick fix when it comes to their health. With dietary supplements so readily available on the market, the public assume that they have been through rigorous testing. Dietary supplements are not tested as much as consumers believe. The Food and Drug Administration (FDA) does not initiate the same type of testing and analysis for supplements as it does for food, drink and medication. Given that people are now choosing supplemental meal replacements and the like, as opposed to whole foods, regulations drastically need to be stepped up in an effort to emphasise public safety. …

Addiction-Informed Immigration Reform, Rebecca Sharpless

Articles

Immigration law fails to align with the contemporary understanding of substance addiction as a medical condition. The Immigration and Nationality Act regards noncitizens who suffer from drug or alcohol substance use disorder as immoral and undesirable. Addiction is a ground of exclusion and deportation and can prevent the finding of "good moral character" needed for certain immigration applications. Substance use disorder can lead to criminal behavior that lands noncitizens, including lawful permanent residents, in removal proceedings with no defense. The time has come for immigration law to catch up to today's understanding of addiction. The damage done by failing to …

Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi

Journal of the National Association of Administrative Law Judiciary

This comment explores the types of legislation, approaches to regulating e-cigarettes, and analyzes whether the FDA’s campaign and current regulations are effective. So far, it appears that the United States is ahead of the game with its new, aggressive proposal for regulating e-cigarettes. The FDA is standing against the companies and products that target youthful consumers. Most countries acknowledge the gaps in current scientific research regarding the long-term health risks of vaping, and some are waiting to take a legislative stance until it is clearer which side of the health line e-cigarettes fall. Section II of this comment discusses the …

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

When "Things" Go Wrong: Redefining Liability For The Internet Of Medical Things, Bethany A. Corbin

South Carolina Law Review

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Forbidden Flower: How Allowing Medical Cannabis Flower In West Virginia Helps Heal Patients And The State Economy, Jordan Maddy

West Virginia Law Review

No abstract provided.

Federal Regulatory Responses To The Prescription Opioid Crisis: Too Little, Too Late?, Lars Noah

Utah Law Review

Part I of this Article suggests that the medical establishment shares more blame for the crisis than many commentators seem to appreciate. Part II canvasses a variety of ways in which the federal government has responded to the opioid problem during the last few years before delving more deeply into the FDA’s role in the mess, assessing the different tools that it has tried to use as well as some that it failed to employ. This Article concludes that the agency should have allowed only a narrowly defined subset of physicians to prescribe opioid analgesics, even though the medical community …

Seeking Insurance Parity During The Opioid Epidemic, Valarie K. Blake

Utah Law Review

Private insurance covers almost 40 percent of people with opioid addiction. Yet, amid an epidemic with profound consequences for individual and public health, private insurers continue to fuel addiction by favoring addictive but affordable pain therapies over nonaddictive ones and by placing unreasonable, sometimes unlawful, hurdles and delays in the ways of addiction treatment. Action must be taken now to address these harms. Laws like the ACA and the MHPAEA need greater enforcement, while gaps in these laws can and should be addressed through broader federal and state initiatives. Private insurers must be regulated, and swiftly, to ensure that people …

From Health Policy To Stigma And Back Again: The Feedback Loop Perpetuating The Opioids Crisis, Nicolas Terry

Utah Law Review

Between 1999 and 2017, almost 400,000 people died from opioid overdoses, and since 2001, the opioid crisis has cost the U.S. more than 1 trillion dollars. In late 2018, the Department of Health and Human Services (HHS) Secretary opined that the country was “beginning to turn the tide” in responding to the crisis. Secretary Azar’s positive statements were based on preliminary CDC data that showed a national decline of 2.7 percent in drug overdose deaths from October 2017 to May 2018. However, data still show over half the states posting an increase in overdose deaths with a concentration of higher …

America’S Favorite Antidote: Drug-Induced Homicide In The Age Of The Overdose Crisis, Leo Beletsky

Utah Law Review

Nearing the end of its second decade, the overdose crisis in the United States continues to claim tens of thousands of lives. Despite the rhetorical emphasis on a “public health” approach, criminal law and its enforcement continue to play a central role among policy responses to this crisis. A legacy of the 1980s War on Drugs, statutory provisions that implicate drug distributors in overdose fatalities are on the books in many U.S. jurisdictions and federally. This Article articulates an interdisciplinary critique of these “drug-induced homicide” laws at a time of their increased popularity, expanding scope, and aggressive prosecution. That these …

Marijuana Issues For Voters: Studying Issues Us States Have Had With Legalizing Marijuana, Kody Kesler

WRIT: Journal of First-Year Writing

In the United States, the legalization of medical and recreational marijuana in individual states, rather than the whole nation, is a great example of states being “laboratories of democracy.” Legalizing marijuana in the states first is essential to deciding how to go about the issue on the national level, once Americans are ready for it. In most states where it is legal, employees can still be fired for having marijuana in their system, even if they have a medical recommendation. The drug tests that employers use don’t test for the recent use of drugs like marijuana, but for a part …

Due Process Supreme Court Appellate Division Second Department

Touro Law Review

No abstract provided.

Pharmaceutical Industry Funding To Patient-Advocacy Organization: A Cross-National Comparison Of Disclosure Codes And Regulation, Laura Karas, Robin Feldman, Bai Ge, So Yeon Kang, Gerard F. Anderson

Articles

Transparency has become one of the primary themes in health care reform efforts in the United States and across the world. In the face of exorbitant drug prices, high levels of patient cost-sharing, and pharmaceutical expenditures that consume a growing proportion of public sector budgets, much attention has been drawn to the pharmaceutical industry. Congressional investigations, academic publications, and news articles have endeavored to reveal the extent of drug and device industry influence on health care actors. In response, several nations, including the United States, have passed legislation mandating disclosure of drug company payments to physicians. In the United States, …