Off-Label Innovation: CIPIL Evening Webinar

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Cambridge Law Faculty published this video item, entitled “Off-Label Innovation: CIPIL Evening Webinar” – below is their description.

Speaker: David A. Simon, Harvard Law School

Biography: David A. Simon is a Research Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, & Bioethics at Harvard Law School. From 2020-2021 he was a Visiting Associate Professor of Law & Frank H. Marks Intellectual Property Fellow at The George Washington University Law School. From 2019-2020, he was a Visiting Assistant Professor at the University of Kansas School of Law and a Fellow at the Hanken School of Economics in Helsinki, Finland. His scholarship–which focuses on health, intellectual property, innovation, and torts–has appeared or will appear in a variety of legal publications, including the Boston College Law Review, the Georgia Law Review, the Florida Law Review, the Washington Law Review, the William & Mary Law Review, and the Yale Journal of Law & Technology.

David holds an LL.M. from Harvard Law School, where he was a Summer Academic Fellow, and a Ph.D. from the University of Cambridge, where he was a Cambridge International Scholar (full tuition scholarship & stipend) and member of Trinity College. His dissertation examined the philosophical underpinnings of so-called authors’ rights (droit moral) in copyright law. He earned his B.A., with high honors, from the University of Michigan, and his J.D., with high honors, from Chicago-Kent College of Law, here he was selected to the Moot Court Honor Society, Order of the Coif, and Dean’s List. During law school, he won several writing awards for work in constitutional law and intellectual property law.

Abstract: Modern medicine faces two significant challenges. The first is that approved drugs have many potential therapeutic uses that are never identified, investigated, or developed. The second is the routine practice of physicians prescribing approved drugs for unapproved uses—so-called “off-label” uses. These problems seem very different. Failure to invest in potential new uses is an innovation problem: firms lack incentives to research and develop new uses of old drugs. The problem of off-label uses, on the other hand, is one of safety and efficacy: off-label uses are risky because they aren’t supported by the same level of evidence as approved uses. While descriptively accurate, this is not the only accurate description. Each of these problems is also one of information—a lack of information about the safety and efficacy of prescribing approved drugs for unapproved uses. Because all new uses of approved drugs are off-label uses, gathering safety and efficacy information about off-label uses, in effect, produces safety and efficacy information about many new uses. Not only that, but some off-label uses may be new: physicians may innovate by prescribing drugs off-label. Reframing these two seemingly disparate problems in terms of a common information deficit enables a single, information-based solution. This solution—which draws on the existing suite of innovation policy levers—incentivizes providers, rather than pharmaceutical companies, to generate the post-market information needed to address both problems.

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