The Alliance's Assessment of the President's FY 21 Budget Request
In relative terms, we are pleased that the Administration’s commitment to FDA remains strong, even while many other worthwhile agencies are proposed for cuts. In absolute terms, further increases are going to be needed for FDA because the mission and responsibilities of FDA are still growing and the science is becoming more complex.
Q: What is FDA’s current and the President’s proposed funding levels? A: In FY 20, FDA received a budget authority (BA) appropriation of $3.159 billion for “salaries and expenses”. The President is proposing a $47 million increase (about 1.5%) for FY 21, which would bring the agency BA funding level to $3.206 billion.The Alliance has always used the salaries and expenses (S&E) number in describing FDA funding levels, because S&E is the most accurate reflection of FDA’s programmatic activity that is paid from the BA appropriation. In comparison to our numbers, the Administration’s summary document variously uses numbers that show an increase of between $23 million and $25 million. This reflects their decision to net out a $5 million decrease in Cures funding and an $18 million decrease in Building and Facilities (B&F) that was boosted in FY 20 by monies largely intended to be one-time investments. Note that Cures funding comes from reductions in mandated spending and is not BA (taxpayer) funding and Building and Facilities is carried as a separate account from S&E monies.The President’s proposal for FDA for current law user fees for FY 21 is $1.96 billion, excluding tobacco user fees. The proposed $78 million increase in existing user fee programs is based on the formulas in the current user fee agreements. Therefore, the proposed funding does not represent any increase or decrease in Administration support.Q: What is the Alliance’s most important message?A: “Growing responsibilities require a budget that grows.” For this reason, our advocacy will emphasize ways in which the agency’s responsibilities have grown (breadth) and ways in which the job has become more complex (depth). To respond to these challenges, the agency needs additional budget, more scientific and technical staff, and better analytic tools (such as interoperable data systems) that support scientifically based decision-making. Examples of new technologies for which the agency needs additional capability and personnel: gene and cell therapy, digital health, artificial intelligence, cybersecurity of medical devices, and real world evidence. On the food side, there is whole genome sequencing, culture-independent diagnostic testing, and block chain.Q: Is the President’s budget request “dead on arrival?” A: No. Ignore anyone who says: "Don’t pay attention because the President’s budget is dead on arrival." In reality: whether Congress accepts or rejects the President’s proposals or adds more money, his numbers will be used as a baseline when the subcommittees mark-up. That matters.Editorial note: The Analysis and Commentary section is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA. We apologize once again for the 1 week delay in posting this information to this web site..