Highlights from the 21st Century Cures Act

By Rachel Sachs

At the end of January, the House Energy & Commerce Committee released a discussion draft of the 21st Century Cures Act.  This document marks the beginning of the legislative phase of the 21st Century Cures Initiative, during which the Committee has held numerous roundtables and hearings and issued several white papers.  The first discussion draft of the Act, clocking in at nearly 400 pages (even with several sections “to be supplied”), is incredibly wide-ranging, including proposals that could affect every stage of the innovation process.

The discussion draft should be of interest to everyone in the health policy field.  One series of proposals is targeted at the NIH, including more support for the National Center for Advancing Translational Sciences and for the NIH’s BRAIN initiative.  Another set would act on the FDA, including one provision giving new drugs for unmet medical needs the option of 15 years of exclusivity.  This provision, based on the MODDERN Cures Act, is particularly likely to inspire a great deal of controversy and opposition.  The draft also contains a series of proposals designed to promote the development of new antibiotics, in keeping with President Obama’s recent focus on this issue.  Its attention to the use of social media by drug companies and to the FDA’s regulation of health-related software will be of interest to many, as well.

The proposed draft is much too long to catalog fully in this brief blog post, although those who are interested in a broader summary might enjoy the 13-page summary of the Act put out by the Committee, the Science summary by Kelly Servick and Jocelyn Kaiser, or Alexander Gaffney’s comprehensive Regulatory Explainer.  But I do want to highlight one section of the draft which deserves more attention than it has gotten: section 2021, which would create a national Medical Product Innovation Advisory Commission.

Based on MedPAC (the Medicare Payment Advisory Commission), the proposed Medical Product Innovation Advisory Commission would “analyze medical product innovation in the United States and recommend policies to accelerate the discovery, development, and delivery of new medical products.”  As such, the Commission would not only be specifically tasked with reviewing policies of the NIH (discovery), FDA (development), and CMS (delivery), but would also be tasked with “review[ing] the interaction of Federal agencies with respect to the discovery, development, and delivery of new medical products and how such interactions influence medical product innovation” (emphasis mine).

Those readers among you who look forward to my posts with great anticipation will know by now that a large portion of my work focuses on exactly this question.  I examine the ways in which the various policies of these agencies interact, generally in conjunction with patent law, to encourage or discourage innovation into various types of medical products.  The lack of required agency coordination or even interaction in this area is one key impediment to achieving a coherent and productive innovation policy, and this Commission has the potential to address it.

Not every proposal in the discussion draft is likely to make it into an eventual bill.  But I for one hope that the proposed Medical Product Innovation Advisory Commission survives.  If created in the image of MedPAC, it has the potential to guide us toward real advances in innovation policy.

This entry was posted in FDA, Health Law Policy, Pharmaceuticals, Rachel Sachs, Reimbursement, 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.