Rising Concerns About User Fees Addendum to: “The Possible Demise of User Fees: Existential Threats Demand…”
January 24, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/keep-calm-and-carry-on-lessons-from-trump-10
Eight years ago, just before President Trump was sworn in for the first time, I expressed my belief in FDA’s ability to survive change. I wrote:
“Despite the stridency of the rhetoric and the substantial uncertainty about 2017, Republicans and Democrats have, for decades, mutually supported an FDA that is well-functioning and fulfills its incredibly important public health mission.”
It is reasonable to have doubts whether this remains true in 2025.
February 14, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/short-takes-and-updatesfebruary-14-2025
1. When Will Congress Engage on the Future of FDA User Fees?
Either the agency is captured by industry (Secretary Kennedy), or it is a hindrance to industry (Vivek Ramaswamy). I understand how it could be neither…but not how it can be both.
The lack of clarity is of concern to nervous corporate executives and many FDA employees. I have pointed out that PDUFA VII and MDUFA V and GDUFA III do not expire until September 30, 2027, with initial discussions only just starting this summer. There is time for this discussion after the new Administration has been in office for a while and taken care of more pressing issues.
I am starting to feel a bit nervous about this answer. So far, the new Administration has shown little patience for waiting on anything. If they feel strongly, they seem to want to engage immediately….contractual agreements and statutes not necessarily representing barriers.
This is not a prediction, just a lessening of my certainty that user fees are off the table until later.
February 18, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/if-being-mission-critical-is-not-important-enough-what-is
Government-wide, protecting the more valuable functions of the government (agencies, service and people) formed no apparent part of the employee reductions[1].
It may be crazy to do a RIF at FDA when laid-off employees are mission-critical to medical advances and food safety and play a key role in national and global commerce….
***
In assessing the current situation, I am left with an obvious question that appears to have no immediate answer: if being mission-critical is not valuable enough to save an employee, service, or program, what is?
February 23, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/special-edition-fda-rifs-and-user-fees-explained
Footnote 3: To assure that user fees did not supplant BA (appropriated) funding, the user fee laws contain “maintenance of effort” provisions for how much BA money must be appropriated before user fees can be collected. The triggers vary for each program. These “maintenance of effort” provisions are not likely to be triggered by lay-offs but become an issue later if Congress tries to shrink the FDA’s BA budget beyond a certain point. We will address this in a future column if it becomes relevant.
[April 4, 2025, observation: assuming a reasonable amount of bookkeeping flex on BA vs. UF staff, the RIF’s as such do not trigger the crisis. Rather, the triggers become an issues when/if Congress lowers FDA’s BA appropriations, which is likely to be part of an upcoming recission package to be sent to Congress]
March 7, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/short-takes-and-updates-march-7-2025
4. User Fees Still Likely to Continue, But Not a Sure-Thing
The process of negotiating the next set of medical product user fees would normally start with some public hearings in the Summer or Fall of this year. That allows enough time to have user fee legislation before Congress by January 2027.
In my Short Takes column of February 14 (here), I suggested that the new Administration might want to begin sooner and have a broader conversation about the purpose and value of user fee programs.
This week, AgencyIQ (in a members-only analysis of recent EO’s and prior RFK, Jr.’s statements) concluded that “user fee programs could undergo major reforms, or even be terminated, during the next reauthorization cycle – all over concerns about undue “industry influence.”
March 27, 2025 story in Roll Call: https://rollcall.com/2025/03/27/targeting-fda-user-fees-would-leave-agency-gutted-experts-say/.
Steven Grossman, a regulatory consultant at HPS Group and author of the FDA Matters newsletter, said in an email to CQ Roll Call that his concerns about the future of the user fee program have grown since the Trump administration took over.
“The risk of dramatically different medical product user fee programs — or none at all — has gone from blue (general risk) to at least yellow (significant risk),” he wrote. “If somebody suggested orange (high risk), I would not say they are exaggerating.”
Writing in a Feb. 14 blog post, Grossman said the process for negotiating the next set of user fee programs would typically start with hearings beginning in the summer or fall, allowing time for the legislation to be drafted by January 2027.
“My hope is that it warns stakeholders not to take renewal for granted,” he said in an email.
April 2, 2025 column in FDA Matters: https://www.fdamatters.com/fdamatters/random-arbitrary-rifs-drive-the-initial-makary-agenda
When you stop trying to rationalize what is going on, you get to the simple but startling truth: random, arbitrary RIF’s are intended to:
1/ destroy government credibility and expertise,
2/ demoralize remaining staff,
3/ make it near-impossible to recruit experts in the future; and
4/ reduce staffing levels to where competent program performance will be challenging if not impossible.
It feels like such a big leap to such a radical conclusion—that the mind wants to deny the possibility.
However, you do not downsize the DOGE way if your only goal is a smaller, more efficient federal workforce that serves the American public and its needs[1].
It was done successfully in the 1990’s with a minimum amount of disruption and only modest RIF’s that were implemented at the end of the process. See my analysis of the “Reinventing Government” initiative.