The difference between micro- and macro-budgetary issues and how they affect FDA

For many years, Friday Update has written about the difference between micro- and macro-budgetary issues and how they affect FDA. The macro-budget is the entirety of Federal spending (many trillions of dollars), of which nearly $1.5 trillion is being proposed by the Administration to be spent on discretionary programs (defense, social programs, FDA, etc.) in FY 22.

In contrast, the micro-budget is all about FDA, its priorities, accomplishments, and needs. As an interest group, we can make a difference in how Congress perceives FDA and how that might translate into funding. But no interest group has much impact on macro-budgetary issues that are largely driven by politics.
At this point (September 3), FDA is doing particularly well on the micro-budgetary front (the part we can affect), but resolution of the agency’s funding must await the resolution of the macro-budgetary issues.

The Micro-Budget. For FY 22, the President requested a $343 million increase (more than 10%) over FDA’s FY21 budget authority (BA) appropriation of $3.2 billion. This was a $325 million increase in salaries and expenses (S&E) and an $18 million increase in buildings and facilities (B&F). FDA’s B&F funding has been stable for many years at $12 million—so we rarely have reason to discuss it. These monies would be a welcome investment in FDA’s many facilities needs, and we support FDA and the President’s decision to include it in the budget request. A more detailed description of the President’s proposal (as well as a chart) is at: https://strengthenfda.org/2021/06/04/presidents-budget-request-confirmed-for-fy-22/

Congress’s response to the President’s request has been very favorable. The House passed an FY22 Ag/FDA Appropriations Bill with an 8% increase over FY 21. Specifically, they embraced a $257 million increase for FDA in FY 22. The breakout is + $247 million for S&E and + $10 million for B&F. The Senate Appropriations Committee has also marked up FY 22 bills. Their FY 22 Ag/FDA Appropriations Bill contains a $200 million increase for FDA, more than a 6% increase. The breakout is +$197 million for S&E and $3 million for B&F. Both bills (as well as the Administration’s request) include $50 million for 21st Century Cures-authorized programs. Those monies are not BA and therefore are additional and not included in any of these totals.

To complete the micro-budgetary cycle, we need the Senate to complete action on their bill—or has often been the case, negotiate final FDA numbers based on House-passed and Senate Committee-passed bills. So, we are very close to the finish line. However, that is where delays caused by macro-budgetary issues start to impact FDA funding.

The Macro-Budget. Nothing prevents Congress from passing a few funding bills and sending them to the President without an agreement on overall spending. However, this is extremely unlikely.

More likely is that Congress will fund the government through Continuing Resolutions if there is no FY 22 spending agreement by September 30. Other than a government shutdown (unimaginable this year), a CR is the worst case for FDA. The agency would only be able to spend at the FY 21 levels and face some restrictions on initiating new programs.

If there is a CR, one key variable is how long it lasts--to the end of October, after Thanksgiving, or into next year? That provides a sense of when Congress expects to be ready for serious compromises….and defines when FDA will be able to put its FY 22 micro-budgetary gains into strengthening its current efforts and begin new initiatives.

And all of this colors what we must prepare for when the FY 23 budget request is sent to Congress, presumably in February. Stay tuned.


For information about past and future programs, contact Steven Grossman at sgrossman@strengthenfda.org.

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Potential for a long endgame on appropriations; A government shutdown is highly unlikely, but not unimaginable.

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House/Senate Appropriations have finished Ag/FDA funding, long end game lies ahead; FDA Rulemaking Authority restored, Sunset Rule delayed