Clarifying some issues about FDA budget and appropriations.

Q: Why are there different--seemingly inconsistent--numbers for how much the Administration, the House and the Senate proposed for FDA increases in budget authority (BA) for FY 22?

A: We are confident that the correct numbers are: Administration (+ $343 million), House (+ 257 million), and Senate (+ $200 million). Because of rounding, some sources may be different by one or two million dollars more or less.

There are two components to BA funding: salary and expenses (S&E) and buildings and facilities (B&F). Because B&F is a modest amount and has been level funded at $12 million for years, it previously has not been a factor in the Administration’s, the Congress’, or the Alliance’s discussion of BA funding. For FY 22, the Administration decided that additional investing in physical infrastructure was worthwhile and proposed +$324 million in BA salaries and expenses and +$19 million in BA buildings and facilities. The comparable numbers for the House are +$247 million/+$10 million and for the Senate are +$197 million/+$3 million. In the President’s request and the House and Senate summaries of their FDA funding positions, there are instances where only the S&E number is referenced, leading to confusion about the correct totals.

Some sources have attempted to reconcile the apparent discrepancies by reference to 21st Century Cures funding. Cures is always handled in a separate section by the appropriations committees because technically it is savings from mandatory spending (dollars generated by changes that reduce costs in entitlement programs). It is not BA (direct from the Treasury) funding. Not only are the two pots of money separated in the bill text, but we cannot remember any instance where Congressional documents added the Cures funding to the BA funding.

Q: How do directed program allocations in the committee reports relate to the overall proposed increases for the agency?

A: The committee reports accompanying appropriations bills almost always include Congressional direction on how some portion of the money should be spent (e.g., in the case of FDA, how much money is to be spent on opioid programs). Often overlooked is that items cited in report language are not necessarily new funds. In many cases, they repeat directed funding specified in the prior year’s appropriations committee reports and are, therefore, already in the agency’s base funding (i.e., not new, or additional funding). Because there is no correlation, the directed funding can mask the amount of new incremental programming that the agency can devote to initiatives contained in the President’s budget request.

Q: What points should I make in a letter of thanks to appropriators?

A: Short and sweet is generally good. Both the House and Senate bills include substantial increases for FDA and appropriations leaders in both chambers deserve our sincere thanks. In addition to expressing gratitude, your missive to lawmakers can reinforce a couple of key points. First, the FDA’s mission is incredibly important to our nation’s public health and safety. It’s also a vital component of the economy. Second, the FDA operates in an incredibly dynamic environment and its responsibilities continue to evolve at a rapid pace. These circumstances create myriad challenges which need a strong workforce and financial resources to get the job done. Please reach out to OFW staff (RSzemraj@ofwlaw.com or Pkarsting@ofwlaw.com) if you have any questions or desire further input.