Level Funding for FY 18 Will NOT Allow FDA to Meet All Current Needs

FDA’s responsibilities and mission expand each year -- sometimes explicitly through new laws, but often because the public health and safety role of the agency has become enlarged by changing circumstances. Examples of the latter include: globalization, increased scientific complexity, the acceleration of innovation, public health emergencies, and national security. To meet its increased responsibilities, FDA needs year-over-year additions to its budget authority (BA) appropriation.Cost-savings to offset increases are possible. In any given year, some projects may be completed, some functions may be performed more efficiently than previously, and some priorities become less important. However, FDA’s new, additional, and growing responsibilities always exceed the opportunities for cost savings. There may be agencies where “getting more for less” is feasible. With FDA, the reality is: if you want more, it will cost more.One reason is FDA is a staff-intensive organization, with more than 80% of its budget devoted to staff costs (salary, benefits, rent, IT, training, travel, etc.). As a result, expanded tasks invariably require more manpower and, thus, require more money. The agency’s ability to fulfill its mission is at stake. Meantime, FDA has multiple offices and functions that are understaffed and there are consequences from this. Filling vacancies (and we applaud the Commissioner’s initiative on this topic) will ease this situation, but lack of manpower will be an issue even when all open slots are filled.FDA’s role does not shrink if it lacks sufficient money. Invariably, something important is undone or delayed or the agency says “No” because it doesn’t have the time and manpower to fully consider the possible benefits of a “Yes.” A lot of agency staff work long hours to try to lessen the harm from insufficient budget and manpower, but at some point they burn out, too. Anyone who has spent time with FDA knows how hard people work.Why mention these thoughts now? First, because we don’t want anyone (particularly Members of Congress and staff) to think that level funding of FDA will allow FDA to meet all the needs created by existing laws and charging demands on the agency. We are grateful to have avoided cuts, but we can’t back down from saying: more BA funding is needed. Second, over and above the first point, there are a number of unfunded non-user-fee activities contained in the pending FDARA legislation. Level funding in FY 18 will not be sufficient to cover FDARA.We hope to continue fruitful discussions with Congress about FDA’s expanding duties and the pressures on the agency to build and retain critical medical and scientific personnel. Please support our efforts and make sure FDA’s budget and manpower needs are also covered in your own outreach activities. If you need help, just let us know.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.