And Now for Something a Little Different!

Question: Usually the Alliance produces analysis and charts with very detailed information about the President’s request and it is available the same week. Why is this year different?Answer: The Administration has not yet published the detailed budget justification for FDA (300+ pages), which would allow us to more precisely explain where new funds would go and how much BA funding each Center would receive. The “budget-in-brief” document we are working from is available here. The FDA section starts on page 17 of the PDF, which is page 13 of the text. Note that the top part of the table is total program revenue and the bottom part is income from user fees. The BA is summarized  ($473 million increase), but more detail about BA spending cannot be derived from the information provided.Question:  How is the President’s FY 19 request different from his FY 18 request?Answer:  In both years, the President has demonstrated support for FDA by asking for substantial increases in agency funding. However, last year’s proposal would have accomplished this by cutting hundreds of millions of dollars from BA (taxpayer) funding and replacing those dollars with an even larger amount from new user fees that had never been negotiated and would have shifted the balance of FDA funding away from taxpayer support. The Alliance made clear in its advocacy that the American public is the primary beneficiary of FDA’s activities and should bear an appropriately large role in funding the agency. In contrast, this year’s request recommends a substantial increase in BA funding and does not attempt to substitute user fee dollars.Question: If user fees are not a focus of the FY 19 budget request, why is there $190 million in additional user fee revenue in the President’s request?Answer: Of the $190 million request, Congress does not need to act upon $143 million because those dollars represent annual workload adjustments already built into the second through fifth years of user fee agreements (i.e., this is additional money but not really new money). A further $21 million is for non-controversial renewal of two expiring user fee programs. There are only two new user fees proposed -- $22 million for OTC monograph review and $4 million for export certification.