By the Alliance for a Stronger FDA

The President is going to release his Fiscal Year (FY) 2022 budget request today (May 28, 2021).

In advance of receiving the President’s request, the Alliance for a Stronger FDA has urged Congress to provide the Food and Drug Administration (FDA) with “no less than $200 million (6 percent) above the FY 21 funding level for Budget Authority (BA) appropriations.”  We are hoping the President will request more. In any case, we will provide more details and further clarification once the President’s Budget Request is released, and we have analyzed it.

Our “ask” focuses exclusively on appropriations that come from monies paid by taxpayers (BA) and intentionally does not include user fees and mandated funding (e.g., Cures monies transferred from NIH).  However, OMB’s “headline numbers” for FDA are almost certain to mix the BA number together with existing and any proposed user fees and other non-BA program funding. If so, the OMB number may significantly overstate the amount of new funds proposed for the agency for FY 2022.

This is not a partisan thing on OMB’s part. Regardless of who is in the White House, OMB tries every year to place the President’s request in the best light.

The OMB “headline” numbers will be widely circulated in the media, even though it is unlikely to provide an accurate or meaningful picture of the proposal being made by the President. The important numbers are in the budget tables, not in the OMB summaries.

Here are some of the reasons there may be divergency between the OMB headline numbers and the Alliance request and analysis.

  • Proposed user fees are counted as actual funding, even though they are unlikely to become law or turn into dollars that the agency can spend in FY 2022.
  • Annual increases already built into the user fee agreements are treated as if they are new dollars in the FY 2022 budget.
  • Depending on context, adding BA appropriations and user fees together may provide an inaccurate picture of the President’s budget request. User fee monies are collected for very specific purposes.  They are extremely valuable to the agency but cannot be used to pay for a wide variety of programs or fund new priorities and evolving needs.
  • More than $700 million of the user fees in the budget request are for the tobacco center and not available for FDA’s traditional responsibilities for safe foods and safe and effective medical products.  Over the past few years, 62 percent of agency funding is from BA appropriations and 38 percent from user fees if you exclude tobacco funding. For a more in-depth analysis of how tobacco fees distort the FDA’s budget, go here.

As soon as we have a firm grasp on what the President is proposing, we will be back to the Alliance membership and media with details that you can rely upon.

About the Alliance for a Stronger FDA: According to the organization/s website, The Alliance for a Stronger FDA works to ensure annual appropriations that will adequately fund the FDA’s essential missions, and we believe that the American people expect this too. There is no backstop, no other agency, that performs this critical work. On December 14, 2007, the Alliance for a Stronger FDA was formed through a merger of two predecessor organizations — The Coalition for a Stronger FDA and the FDA Alliance. This merger created a multi-faceted organization dedicated to securing a higher level of congressional funding for the Food and Drug Administration. 

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