A Seat at the Table: Behind the Scenes of the NIH-FDA-CMS Leadership Councils

One of the questions (or more accurately, lamentations) that I frequently hear when I am out amongst our stakeholder community is “Hey, wouldn’t it be great if you and other federal agencies got together and actually talked?”  Personally, I couldn’t agree more with this sentiment, and I wanted to take the opportunity to say unequivocally in response “YES!!  We actually do this pretty regularly.”  I want to highlight two successful and ongoing relationships that NIH has with some of its most important federal partners, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS).

Let’s start with the NIH-FDA Joint Leadership Council.  As broad opportunities in translational research have come to the fore, it became clear that better coordination between agencies was necessary to fully take advantage of those handoffs from research to medical advancement.  As a result, the Joint Leadership Council was created, co-chaired by the NIH Director and FDA Commissioner, with senior staff from NIH Institutes and FDA Centers comprising the rest of the committee.  While the public perception of such interagency discussions might be “all talk and no action”, I am pleased to say that this effort has resulted in tangible products and improvements.

Some examples of what has come out of the leadership council include the BEST Resource and the NIH-FDA Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials.   The BEST Resource came from the council’s recognition that a lack of consensus on terms used in translational science and medical product development was impeding research progress.  A working group of NIH and FDA leaders created a living glossary of important biomedical terms to ensure everyone was speaking the same language. As for the NIH-FDA template, that was developed with the goal of making it easier for investigators to prepare consistently organized protocols that can be easily reviewed by the FDA.  As a further extension of that, NIH then turned the template into the Clinical e-Protocol Writing Tool, which has been a huge success, drawing almost 2,000 visitors last month alone!

Another successful example of idea sharing between agencies is the NIH-CMS Leadership Council, which is of similar composition to the NIH-FDA council and is led by the NIH Director and CMS Administrator.  With CMS as the largest purchaser of health care in the United States, and NIH as the largest source of public funding for medical research in the world, it makes perfect sense for these agencies to work together.

NIH and CMS have used this forum to think about how to move NIH research results on evidence-based care into practice. As result of these discussions, a joint informational bulletin was sent out by CMS, NIH, and the Substance Abuse and Mental Health Services Administration (SAMHSA) to State Medicaid Directors regarding coverage of early intervention services for initial episodes of psychosis.  This was an important event because NIH research has shown that coordinated specialty care is a better treatment option, and this approach is more likely to be available to patients if it is covered by Medicaid.  Some of the other topics that this council has discussed include coverage of ancillary clinical care costs, physician reimbursement in clinical trials, and genomic medicine resource sharing.

NIH is always looking for ways to coordinate and collaborate with our partners to identify common problems and come up with solutions that will benefit the research community.  Leadership level councils are not the only such vehicle – truthfully, interaction between agencies takes place on a nearly daily basis between subject matter experts – but they do represent an effective way to ensure our agencies are working together to achieve our missions. The best news is, since these councils are still active and sharing ideas, I am confident that there will be more positive examples in the years to come.

Carrie D. Wolinetz, PhD
Former Associate Director for Science Policy, NIH