Administering Health Innovation image

Cardozo Law Review, Forthcoming 2018
Rachel E. Sachs (Academic Fellow Alumna)

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Abstract

Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion of access to those technologies. Appreciating the expertise of agencies like the National Institutes of Health (NIH), Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services (CMS) has expanded the range of tools contemplated by scholars who had previously focused largely on the United States Patent & Trademark Office.

Yet much of this attention has so far focused on the capacities of single agencies, acting alone. This Article expands the existing scholarly focus, considering not only the potential innovation-related goals to be achieved if each agency acts alone, but also the potential for collaboration across agencies. This Article begins that conversation, drawing not only on the health innovation policy literature but also on the growing administrative law literatures focusing on inter-agency and intra-agency coordination models.

This Article develops a taxonomy of potential modes of collaboration, demonstrating how these agencies, which lack formally shared regulatory authority over the innovation space, nonetheless may collaborate to promote incentives for innovation. These agencies do sometimes collaborate to advance goals which are common to the agencies. But they can do more. These agencies may complement each other, accomplishing together socially valuable ends that cannot be accomplished alone. By considering each agency’s core competency, this Article develops specific proposals for agencies to work together going forward.

This Article goes on to consider legal barriers to existing collaboration and potential procedural mechanisms for enhancing collaboration between these agencies for the purpose of achieving health innovation policy goals. Ultimately, it argues that a combination of reforms both internal to and external to the executive branch might be most useful in achieving these goals.

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fda health law policy innovation medicaremedicaid rachel sachs regulation