It's Going to Get Tougher From Here

We are all familiar with the primary case for FDA funding: a broad mandate for a relatively small agency; core function of government; mission and responsibilities are growing; and funding needed to continue the transformation into a 21st Century regulatory agency that can keep up with advances in science and regulated industries.Flat funding, which may occur in FY 18, is tantamount to a year-over-year cut in available resources. Among other things, the agency is obligated to expand the breadth and intensity of its activities each year by an amount that far exceeds any possible offsets from internal cost-savings. Thus, agency leaders must figure out each year how to “get the job done” with fewer resources than are needed. They have limited options if Congress does not provide adequate funding because no other public or private agency performs the role that FDA does. If FDA doesn’t do its job, no one will.Also, FDA does not have the luxury of reducing grants or contracts in order to have more funding for its core activities. More than 80% of FDA’s funding already goes to the costs of maintaining its workforce. That is, salaries, benefits, travel, rent, training, IT, etc., represent most of the agency’s expenditures. This is as it should be: FDA’s mission requires dedicated agency staff in order to assure both integrity and excellence. Beyond that, there is ample room for the agency to involve outside expertise -- which it does -- through advisory committees, public meetings, grants to state food agencies to avoid duplicate inspections, and contracts for specialized expertise, particularly from academia.Two sets of pressures will be felt particularly strongly in the coming (FY 18) fiscal year. First, is the shortfall of needed funding, as described above. This will be exacerbated by new (non-trivial!) responsibilities under 21st Century Cures and FDARA that cannot be paid for with user fees and must be paid for with BA appropriations dollars. Second, FDA needs to put the focus and resources into fully staffing the slots it has been given. This is a continuous drain on current activities that need staff to achieve results. Increasing the percent of filled slots, as well as reducing attrition are key goals of Commissioner Gottlieb and Secretary Price and we applaud the emphasis they have placed on this.The fight for FDA resources has, over the last decade, been extremely successful. There was only one year where BA appropriations decreased (because of sequestration), which was more than offset by a number of years where the agency received substantial new resources. However, it is clear that the fight is only going to be tougher from here on out. That’s why your membership and participation in the Alliance are so important.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA