At CDER and CBER ... Three Positives and Three Concerns

Earlier this month, the Alliance met with leadership from CDER and CBER as part of our efforts to stay abreast of resource issues at the agency. The agency is committed to moving forward despite the increasing mismatch between growing responsibilities and available funding.The central reality is: we keep hearing that Congress is deadlocked on legislation, but FDA is one of a handful of exceptions.  A combination of circumstances and new legislation means that FDA keeps getting more to do.Based on the two meetings, here are three good things about CDER/CBER’s current efforts and three things that are troubling about their situation.

Positives:CDER and CBER are implementing breakthrough drugs and other innovative programming.  The rapid growth in biologic and pharmacologic knowledge is leading to greater challenges in product development, evaluation and safety. With budgets shrinking compared to workloads, doing less is seemingly inevitable. Neither CDER nor CBER accept this and are trying their best to respond creatively in the face of complex challenges.

CDER and CBER employees appear to be rising to the funding challenges by prioritizing their workloads and putting in the extra hours required to get the most important activities done. FDA’s sense of mission is strong and commitment levels are high. CDER and CBER employees know what they do every day matters to the American people as well as the global community.

Buildings have been completed and outfitted at White Oak so that CBER can move into new space in the first half of 2014. During a small window of time, this is certain to be disruptive. However, the pay-off should be enormous: new efficient workspaces, modern laboratories and immediate access to FDA and particularly CDER colleagues.

Concerns:  Prioritizing workloads and putting in extra hours is ultimately unsustainable. This is an exemplary short-term approach; one required by CDER/CBER’s predicament and addressed by strong employee commitment to the Centers’ missions. However, this eventually risks employee burn-out ... plus it is a fallacy to believe that “less important” is the same as “unneeded.” What gets less attention will have consequences in the long-run.

New positions required by FDASIA and other laws are not yet available for hiring. Money provided for new activities doesn’t become employees until funds are apportioned by function and unit. This process has been delayed

Severe cutbacks in travel funding are handicapping the ability of the two Centers to carry out their rulemaking, scientific and international responsibilities.  Government travel cutbacks has played out poorly in the national media, so there isn’t likely to be much Congressional sympathy on this issue. Nonetheless, as CDER and CBER describe the consequences, it is clear that travel cutbacks are a serious problem for FDA and contribute to inefficiencies and missed opportunities.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.