Status of User Fee Reauthorization Legislation

The House-passed and the Senate HELP Committee-passed user fee reauthorization bills both include non-user fee provisions. There is a prevalent view within Congress that House-Senate conferees can work quickly to resolve differences before October 1. A dissenting view holds that the best option is to pass clean user-fee reauthorizations immediately and to address the non-user fee provisions separately and later.
 
There is palpable anxiety at FDA and in the stakeholder community about the lack of a user fee agreement so late in the process. For existing FDA staff, the current period of uncertainty affects operational cohesion and morale. For individuals being recruited, some merely waiting for a signed employment letter, there is the threat of a permanent loss for the agency, as many may take their skills elsewhere.
 
Then there is the money itself. Medical products user fees come to about $2 billion dollars, while budget authority (BA, taxpayer funding) is about $3.3 billion. That makes the monies at stake about 40% of the agency’s non-tobacco budget.
 
Useful background about the sources of FDA funding is here; why the Alliance focuses on BA appropriations and not user fees is here; and why we don’t count tobacco user fees—and you shouldn’t either-is here.) 
 
The relevant House and Senate committees and their leadership have a long history of working together for the benefit of the health and safety of the American people. Further, all the Representatives and Senators involved in these negotiations understand the need for timely action and the impact of delay on agency functioning and funding.
 
As stakeholders, we need to trust in that history of working together. Because I have that trust, this has been my emphatic response to reporters who ask “...what happens if an agreement cannot be reached?”

"There will be a user feel deal. Full Stop. Details may be undecided; consequences may be uncertain. But there will be a deal."

That conclusion does not ease the anxiety and concern that FDA and others are feeling, nor does it suggest when and on what terms an agreement will be reached.
 
In all likelihood, what will happen over the next 4 weeks is still unwritten. There is no secret plan waiting to be revealed. Do not fixate on stories and rumors that come from those “having talked to a key staffer” or “heard from a plugged-in lobbyist.” If the Congressional leaders on the reauthorization legislation have not yet decided, how can those individuals know what will happen?
 
Here are my perspectives on some of the other issues being discussed:

  • Lay-off Notices. We have heard nothing certain about when these will be issued, although we expect it to be decided soon. Everyone is already “on notice” without the letters needing to be sent. Therefore, FDA, OPM, and the unions may still  be looking for a way to avoid the written notices without violating the law.

  • Carry-over Balances. If no agreement is reached by October 1, carryover balances may lessen or delay some of the consequences, However, the extent these balances could mitigate the negative impact to the agency’s work is unclear.

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The Impact of a Continuing Resolution

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FY23 CR; No Change to User Fees; FDA Human Food Programs Review Panel Members