FDA Purchasing Power is on the Line

Earlier in September, Dr. Jeff Shuren, director of CDRH, presented to the Alliance membership at our quarterly meeting. It was an impressive presentation, providing us a sense of both the breadth and depth of CDRH activities.

One of Dr. Shuren’s slides dealt directly with the purchasing power of the agency’s BA appropriation. Using FY 05 as a base, CDRH’s purchasing power has decreased by 25% over the succeeding years--at a time when its mission expanded, its workload multiplied and its job grown more complex. Here is the slide:While an accurate representation of the dilemma faced by a center director -- how to squeeze more out of a budget that is shrinking relative to costs -- I think the slide substantially understates the degree of cost pressure that has been created.

First, FDA was already grossly underfunded in FY 05, the base year. Second, the relative simplicity of the devices reviewed in 2005 cannot be compared to what CDRH faces in 2016. The same could be said for the policy issues that have grown significantly more complex over the 12-year period. At the same time, the medical technology industry and the patient stakeholder community have grown larger and more sophisticated, requiring more staff time and infrastructure to service. Yet another element is the internationalization of medical product markets, requiring more awareness of global issues and more worldwide presence for the FDA. Finally, there is the organic growth of the Center’s mission, little or none of which has been paid for. An example is the increasing prominence of combination products.“Doing more with less” is an attractive proposition -- particularly in the political realm. However, it runs against the reality that most often “doing more requires more.” That is certainly the case for FDA.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.