Q&A about User Fees, Budget Information, and Reconciliation

Q: Congress has begun moving user fee reauthorization legislation. Why is August 1 so important?

A: While the user fee programs expire on September 30, 2022, it is imperative that legislation reach the President’s desk by August 1. Otherwise, lay-off notices could be sent to thousands of FDA employees whose work is supported by expiring user fee programs.

As I was bluntly told this week: “Congressional assurances notwithstanding, these required written notices freak out FDA employees no matter how earnestly someone tells them that the user fee will be reauthorized before the 60-day period is over.” I would add: all of this is bad for morale, recruitment, and retention.

There is good news. Leadership of both House E&C and Senate HELP are taking the August 1 deadline seriously. So far, bills are moving at a pace that is consistent with completion before August 1.

Q: The President’s FY 23 Budget Request for FDA is a hefty 413 pages. How can I quickly identify the parts that matter to me and understand what is being requested?

A: The Alliance has many ways to help you. When we receive the budget request, we first look at the All-Purpose Table (pages 30-35) and the Budget Authority Crosswalk (pages 36-38). In trying to understand funding for food safety, medical products, and combined programs, the Major Purposes Table (pages 38-39) is invaluable. After that, each Center and the Commissioner’s Office have separate sections on budget and program priorities. All of this can be dry and confusing. Let us know your questions.

A complementary approach (less dry and less confusing) is to listen to the Alliance’s FY 23 Budget Priorities webinar series with FDA Center directors. There were six programs encompassing the priorities of CDER, CFSAN, CBER, CDRH, CVM, and the Office of Regulatory Affairs. We have audio, summaries and, in most cases, transcripts of these webinars. For more information, go to https://www.strengthenfda.org/events.

We also recommend the Alliance’s House and Senate testimonies on FY 23 funding. Finally, Alliance staff are glad to participate in webinars and meetings where we can present and discuss “How FDA Is Funded.”

Q: Why is there renewed discussion about reviving budget reconciliation legislation and might FDA be affected?

A: There are four months left in FY 22, which means budget reconciliation could still become a vehicle for passage of a large number of budget-related programs. Under reconciliation, only fifty votes are required for passage, which means Democrats would need to have buy-in from Senators Manchin and Sinema. Alternatively, there is discussion of a bipartisan package, centered on climate and energy policies.

FDA is unlikely to be affected by reconciliation except in one regard: paying for technology and facility modernization. Earlier this year, both House and Senate reconciliation bills (considerably larger than what could pass today) included $300 million—split evenly between technology and facility upgrades for the FDA. Given the almost-certain reduced size of reconciliation—if it occurs at all—means that FDA’s chances of receiving assistance is diminished but not out of the question.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.