Why Commissioner Hamburg is Already Talking About the FY 14 Budget

This week’s "Pink Sheet" carried the following item:  "Speaking with FDA’s Science Board, FDA Commissioner Dr. Margaret Hamburg reported that FDA is preparing a FY 2014 budget that may include both cuts as well as new initiatives.  According to Dr. Hamburg, although FY 2014 budget planning is still in its early phases, the budget process offers the opportunity to sort through FDA’s critical priorities.

"This naturally led to some questions from our members about the budget cycle and "wasn’t this a little early for the Commissioner to be talking about FY 14." Here is a quick tour of how long things take and why the Alliance is active 12 months of the year, usually working on more than one budget year at a time.The visible portion of the budget battle is supposed to be 9 months, running from January to October 1, as Congress digests and then acts upon the President’s request. For the Alliance, it is a minimum 12 months per year process because: (a) Congress had not been doing a good job of getting the current cycle done by October 1 and (b) in September we increase our efforts to work with FDA/HHS/OMB to urge higher levels for the next fiscal year. We work with the Administration year-round, but the August/September/October timeframe coincides with the time when the FDA’s agency’s budget request is starting to get critical attention at HHS.By comparison, the appropriations cycle for FDA is about 18 to 20 months from start to finish. The budget is put together from the bottom up, with each office and division developing its budget request, then having to compete for resources with others within their center, then center competes with center. Eventually, FDA competes with other HHS agencies for resources. And then HHS competes with other Cabinet departments for resources, with OMB as the arbiter. In short, FDA’s budget process started in March/April of this year for the FY 14 budget. That is the budget the President releases in February 2013 and on which Congress won’t ultimately decide until the Fall of 2013.We tend to leave the FDA internal process alone because it is not our jobs to tell FDA how to spend its money. If they ask us questions, we certainly respond. The FDA process is done by about Labor Day ± 30 days. Meantime, we have no problem talking to HHS, OMB and the Office of the President about FDA’s resource needs. We ask them to look kindly on the agency request (even without knowing the actual amount) and to consider whether even more funding might be needed. Tying the calendar together, that’s puts us at the September/October time when we get busy with HHS and OMB. Also, as noted, we talk to HHS and OMB outside this cycle, but we always follow this Fall schedule, regardless.Which brings us back to Dr. Hamburg’s comments. FDA is in the early stages of preparing the FY 14 budget, which is an extremely lengthy process of 18 to 20 months. It would be natural for her to share some ideas and get some feedback from the Science Board that advises her ... exactly because it is early in the process and the agency may get some additional perspective.

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