FDA Law SSRN Reading List - August 2017 image

Objective Intent Blog, September 14, 2017
Erika Lietzan, highlighting work by Rachel E. Sachs (Academic Fellow Alumna)


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From the post: 

Rachel Sachs, Administering Health Information (forthcoming in Cardozo Law Review).  Professor Sachs (Washington University, in St. Louis) explores the potential for three federal healthcare agencies (NIH, CMS, and FDA) to collaborate in order to promote the development of new and innovative health technologies and improve access to those technologies.  She starts with a description of the innovation incentives administered by each agency, taking a broad view of what constitutes an innovation incentive in the first place. (Thus, for instance, approval of a new drug is considered an incentive to produce information about its safety and effectiveness.  And, as she has argued elsewhere, prescription drug insurance administered through CMS provides a reward for research and development and thus operates as an incentive.)  Following a discussion of three methods of collaboration among these agencies – information sharing, research, and decision making (such as product approvals) – she discusses a variety of specific collaborations that might improve innovation incentives (broadly understood), noting their success and failure to date.  For instance, she covers coordination between the FDA approval process and CMS coverage decisions, noting where it has been attempted and where it has not yet been used (publicly).  The paper concludes with a discussion of the barriers to collaboration and ways to facilitate collaboration.

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