Please Write to Appropriators NOW ... The Clock's Still Ticking

Congress added $25 billion (5%) to the funds available in FY 16 for domestic discretionary programs. This is the budgetary endgame for which we had been hoping. Now that the moment is here, we must do everything in our power to secure additional funds for the FDA.The size of the overall increase is part of what makes this year different. The overall budget ceilings in future years provide for much smaller increases—both in dollar and percentage terms.Further, the FDA’s need for additional funds is here and now.The most pressing area is for increased food safety funding. Simply put, Congress passed the Food Safety Modernization Act (FSMA) intending a substantial overhaul of the food system in the U.S., but then has underfunded its implementation. Every American is put at risk as a result. The Administration requested an increase of $109 million in BA authority for FY 16. Because they also proposed food user fees (that Congress has no interest in and were dead on arrival), we know that FSMA implementation, and food safety programs generally, can use a BA increase above the $109 million level.The Administration has proposed $40 million additional BA appropriations for medical product programs in FY 16, above and beyond what is needed for FSMA. The specific allocation is on pages 7-9 in the Administration’s request. The monies would go to the following programs (including associated overhead costs such as rent): FDASIA implementation, combating antibiotic resistance, precision medicine, compounding and sunscreens.We know that there are additional priorities on the medical product side if Congress were to appropriate additional BA funding. Among those priorities could be several items in 21st Century Cures legislation that meet this standard: FDA is willing to do the projects, the agency has general authority to do so, but FDA lacks funding. An example would be increasing the monies available for the development of biomarkers.None of these good things will happen unless Congress knows the depth and breadth of stakeholder support for increased FDA resources. Letters to key appropriators (and authorizers, too) are needed.Beyond these directions on Alliance messages, if you have questions about what to put in your letter or need more information about the current appropriations “open season,” please don’t hesitate to let Tony know or connect with Ladd or connect with me.My final thought is the same as last week: write your letters to appropriators NOW!Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.