Law Commons^™

‘A Most Equitable Drug’: How The Clinical Studies Of Convalescent Plasma As A Treatment For Sars-Cov-2 Might Usefully Inform Post-Pandemic Public Sector Approaches To Drug Development, Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway

Articles, Book Chapters, & Popular Press

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021. We found that studies were mobilized and scaled at record pace due to well-connected investigators who engaged in widespread sharing of clinical trials resources, regulatory facilitators, and …

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.

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 …

Reconsidering The Rationale For The Duration Of Data Exclusivity, Jonathan Kimball, Srividhya Ragavan, Sophia Vegas

Faculty Scholarship

The paper’s focus is the singular one question of whether the 12-years of exclusivity that was needed in 2008 remains justified in 2019 given that technological advancement reduces the cost and the time for drug discovery? Basically, new and emerging technologies are deployed every day to enhance efficiencies and reduce the time it takes to bring a drug to the market. The paper asserts that as new technologies are adopted and advances in scientific understanding are leveraged, it results in shorter drug development timelines. This factum, the paper asserts should have a bearing to reduce the period of exclusivity granted …

Cancer's Ip, Jacob S. Sherkow

Articles & Chapters

The state of publicly funded science is in peril. Instead, new biomedical research efforts — in particular, the recent funding of a “Cancer Moonshot” — have focused on employing public-private partnerships, joint ventures between private industry and public agencies, as being more politically palatable. Yet, public-private partnerships like the Cancer Moonshot center on the production of public goods: scientific information. Using private incentives in this context presents numerous puzzles for both intellectual property law and information policy. This Article examines whether—and to what extent — intellectual property and information policy can be appropriately tailored to the goals of public-private partnerships. …

Toward A Jurisprudence Of Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e. product approvals) or negative (i.e. abandoned products, product refusals, and withdrawals) — are …

Beneficial And Unusual Punishment: An Argument In Support Of Prisoner Participation In Clinical Trials, Sharona Hoffman

Faculty Publications

Currently, approximately 1.8 million people are incarcerated in the United States at any given time. A disproportionately large percentage of the prisoner population has serious illnesses, such as AIDS and tuberculosis. Prisoners most often, however, are barred from participation in clinical trials, even when conventional therapy has failed, and experimental treatment might provide them with their only hope of survival.

Much of the reluctance to include prisoners in biomedical research is based on history. In the past, prisoners have been severely abused and even tortured in medical studies conducted in the Nazi death camps, Japanese prisoner camps, and correctional facilities …

A Proposal For Federal Legislation To Address Health Insurance Coverage For Experimental And Investigational Treatments, Sharona Hoffman

Faculty Publications

Health insurance coverage for experimental treatments has generated significant debate and frequent litigation in recent years. In many cases, denials of coverage for investigational therapies constitute economically and ethically sound policy. This article argues, however, that health insurance providers should be required to cover experimental treatments in limited circumstances, namely, when they are administered in phase III clinical trials to patients with terminal illnesses who are likely to die within two years. This coverage mandate would help the sickest patients, who have no other treatment options, and would benefit medical researchers, who often face a dearth of patients willing to …