New Discussion Draft of 21st Century Cures Act Released

By Rachel Sachs

Yesterday, a new discussion draft of the 21st Century Cures Act was released, just in time for today’s hearing on the draft before the House Energy and Commerce Committee.  At just 200 pages (although with some sections still “to be supplied”), this version is just half the size of the previous draft.  As such, it is perhaps more notable for what it took out of the original draft than for what it added in.  I haven’t had time to digest fully all of the cuts just yet, but in advance of the hearing this morning I wanted to highlight two significant deletions from the first draft and one potentially significant addition.

First, when I blogged in February about the first draft of the Act, I expressed excitement over the idea of a Medical Product Innovation Advisory Commission.  The Commission would have had the ability to oversee the way in which agencies like the NIH, FDA, and CMS all interact with each other to affect the development and dissemination of medical products.  A significant portion of my scholarship focuses on precisely these ideas, and I was hopeful that the Commission would make it into the second draft.  Alas, it did not.

Second, the first draft of the Act contained a series of very controversial exclusivity provisions.  Chief among them may have been the draft provision giving “dormant therapies” (essentially, new drugs for unmet medical needs) the option of 15 years of exclusivity.  Alexander Gaffney’s Regulatory Explainer on the first draft provides a helpful overview, for those who are interested in learning more about this provision.  But interestingly, this and other provisions relating to increased exclusivity are gone from the new draft.  Now, it is possible that some of this language will reappear later, especially as the section of the draft relating to “Repurposing Drugs for Serious and Life-Threatening Diseases and Conditions” has yet to be supplied.  But in the first draft of the document, the sections for “Repurposing Drugs” and “Dormant Therapies” were separate, so it is not clear that this is likely to happen.

Third and more interestingly, the new draft of the Act appears to increase modestly the NIH’s budget, creating in Section 1002 an NIH Innovation Fund that would provide an additional $2 billion to the agency each year for five years beginning in fiscal year 2016.  The original draft of the Act had a related placeholder provision (Section 4007), but this version adds a proposed dollar amount.  The NIH’s budget is roughly $30 billion a year, and an extra $2 billion each year is a small but still significant increase.

Hopefully, today’s hearing will reveal more information about these and other provisions in the discussion draft.  I look forward to further developments on this topic.

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This entry was posted in FDA, Health Law Policy, Pharmaceuticals, Rachel Sachs, Research Funding by rachelsachs. Bookmark the permalink.

About rachelsachs

Rachel Sachs is an Associate Professor at the Washington University in St. Louis School of Law. Previously, she was an Academic Fellow at the Petrie-Flom Center. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Master of Public Health from the Harvard School of Public Health, during which she interned at the United States Department of Health and Human Services. Rachel's primary research interests lie at the intersection of patent law and health law, with a particular focus on problems of innovation and access and the ways in which law helps or hinders these problems.