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 …

Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise

Faculty Publications & Other Works

In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug …

Fda Publicity And Enforcement In The Covid-19 Era, Jordan Paradise, Elise Fester

Faculty Publications & Other Works

No abstract provided.

Minor Advances, Major Consequences: Hatch-Waxman Administers Exclusivity For Drug Delivery Devices, Taylor Stemler

Mitchell Hamline Law Review

No abstract provided.

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 …

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 …

Puff, Puff, Patent: Identifying And Addressing The Tensions Between The Medical Marijuana Industry, Patent Law, And The Controlled Substances Act, Dustin Boone

Cardozo Arts & Entertainment Law Journal

No abstract provided.

The Impact Of Cannabis Access Laws On Opioid Prescribing, W. Kip Viscusi, Benjamin J. Mcmichael, R. Lawrence Van Horn

Vanderbilt Law School Faculty Publications

While recent research has shown that cannabis access laws can reduce the use of prescription opioids, the effect of these laws on opioid use is not well understood for all dimensions of use and for the general United States population. Analyzing a dataset of over 1.5 billion individual opioid prescriptions between 2011 and 2018, which were aggregated to the individual provider-year level, we find that recreational and medical cannabis access laws reduce the number of morphine milligram equivalents prescribed each year by 11.8 and 4.2 percent, respectively. These laws also reduce the total days’ supply of opioids prescribed, the total …

The “Free Market” For Marijuana: A Sober, Clear-Eyed Analysis Of Marijuana Policy, H. Justin Pace

Lewis & Clark Law Review

Federal law prohibits the possession and sale of marijuana. At the same time, states are not only decriminalizing marijuana but also attempting to provide a regulatory apparatus for its sale. This has created a unique business environ- ment. In some ways, there is a true “free market” for marijuana in states that have legalized it—free, that is, of the legal and financial infrastructure avail- able to fully licit businesses in America.

Contracts may not be enforceable because they lack a legal purpose. Relief in bankruptcy court may not be available, either as a debtor or as a creditor. Use of …

The Current Application Of The Myriad And Mayo/Alice Rulings On Patent Eligibility: Inconsistent Results And Contradistinguishing Biotechnology Products, Skye Cho

Cardozo Arts & Entertainment Law Journal

The note examines the inconsistent application of the patent eligibility framework under Section 101 of the Patent Act, particularly in biotechnology. It argues that despite efforts by the USPTO to clarify the framework through memos and examples, courts have applied it inconsistently, leading to discrimination against biotechnology products. The analysis focuses on key Supreme Court decisions, such as Myriad Genetics and Mayo, and their impact on the patent eligibility of biotechnological innovations. The note highlights the need for clearer guidance to ensure consistent outcomes and fair treatment of biotechnological inventions.

Mphaea & Marble Cake: Parity & The Forgotten Frame Of Federalism, Taleed El-Sabawi

Faculty Publications

Federal parity laws, and their state equivalents, have been shown to increase access to substance use disorder (SUD) treatment, by decreasing the cost of SUD treatment borne by the insured, and has resulted in little increase in health plan costs. Despite these improvements, the effects of parity on access to SUD treatment have been lower than expected. Recent reports suggest that states have varied in their enforcement parity, failures which may explain why persons surveyed still report having inadequate insurance coverage for SUD treatment despite the parity legislation. While other articles have offered suggestions for improving parity, most have lumped …

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 …