Setting the Advocacy Stage for FY 18 and After

Last week’s Analysis and Commentary provided an extensive discussion of the funding available to FDA as part of the 21st Century Cures legislation. The funds must be appropriated from the FDA Innovation Fund, for which $500 million over 10 years has been allotted and offset from savings contained in the Cures bill. We received several questions from readers about our description of the range of possible actions that might be taken by the appropriations committees. We wrote:

The appropriations committees can treat the FDA Innovation Account as additional monies to carry out new responsibilities, which is how they are intended. However, nothing prevents the committees from using these funds to offset an equal number of dollars from the FDA’s BA funding base. In effect, this would require FDA to absorb the entire cost of Cures activities from existing funds and thereby deprive some existing programs of the funding that supports them.

We anticipate that the appropriations committee will appropriate the FDA Innovation Account dollars each year, up to the maximum allowed. Although the appropriations committees get the final say (and might choose not to use money from the Account), it is likely they will because the Cures monies do not count against the budget ceilings imposed on the committees and their subcommittees. The authorizing committees set it up this way in lieu of creating mandatory spending, which was opposed by the appropriations committees. Having found the monies by sales from the strategic petroleum reserve and a number of changes in law that generate budget savings, the authorizers wanted to increase the probability that the funds would reach FDA. And most likely they will. For example, the $20 million allotted for FY 17 has been included in the Continuing Resolution.

The greater risk for FY 18 and thereafter (when the dollars ramp up) is that the appropriations committees might appropriate the Cures funding and then decrease FDA’s base budget authority (BA) funding by an equal number of dollars. Were this done, FDA would acquire a large number of new responsibilities but the agency would not receive net additional funds. Seen another way, FDA might find itself with a significant budget cut imposed upon the agency’s non-Cures activities. Further, the new funding available for Cures is unlikely to cover all the new activities the law will require.

Thus, the passage of Cures legislation will further increase the current gap between FDA funding and FDA responsibilities. The agency will need the Cures funding and more to carry out its mission in both food safety and medical products.The Alliance and the entire FDA stakeholder community must address the funding challenges that FDA faces in the FY 18 appropriation cycle and thereafter. That cycle begins in January.

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