Truth-Telling: FDA User Fee Edition
After 50 years in Washington, I have no expectation of being told the truth by government officials—elected or appointed. I like to think I have seen it all—shading the truth, burying the truth, plausibly deniable truth, and sometimes things entirely made up and called the truth[1].
I try not to be fooled. I imagine that my audience is also world-weary in this regard.
Despite my low expectations, I have never abandoned the hope that someone will come along and prove that you can tell the truth and not lose your job.
Which brings me to my point: I really want to believe in the truthfulness of what Commissioner Makary says. He is smart and earnest, although his hard job has become even more difficult between the time he said “yes” and the time he was sworn in (FDA and Politics: An Unhealthy Combination). More importantly, it is hard to be trusting of him when his boss and his boss’ boss are on such notoriously poor terms with truth-telling.
In an April 2 column (Random Arbitrary RIF’s Drive the Initial Makary Agenda), I laid out some next steps for the new Commissioner. As far as I can tell, he is following them (because they are logical, not because I suggested them). I wrote:
Thus, the single most pressing priority for Commissioner Makary is figuring out what FDA can still do….Equally important, he will have to figure out what the FDA cannot do or cannot complete in a specific timeframe…and address statutory, Congressional, and stakeholder concerns.
There is a lot to unpack there, but today I want to focus on medical products user fees.
Based on the leaked OMB budget memo[2], there is a commitment to finish the current five-year user fee cycle[3], even if the next round is uncertain[4].
In exchange for user fees, FDA has agreed to targets for the amount of time needed to complete certain reviews. The metric is the time, not the people, but it is obvious that FDA cannot be on time if it lacks enough fully staffed review teams to do the work.
There have been a few times in the past when FDA has known, in advance, that it would not make a significant number of user fee due dates. I am fairly sure there was a blip after the 2018-2019 government shutdown. I have a vaguer recollection of a prior blip---maybe associated with the late passage of the 2017 user fee reauthorization bill. [After publication, two readers pointed me to January 2008 when CDER warned that—due to the increased workload from implementing FDAAA requirements and short-staffing—that reviewers were free to miss deadlines for a while. Eventually, the on-time completion rate leveled-up]
Each of those had a discernable reason outside FDA’s control. FDA was able to acknowledge delays and speak generally about when the agency would be back on schedule.
Once Commissioner Makary knows better what he can and cannot do (maybe around June 2 when the RIF’s take effect?), he needs to forthrightly address the shorter term. It is not pocket change: medical products companies have a $5 billion financial commitment to FDA for activities in FY 26 and FY27[5].
They know they don’t get approvals for that money, but they have been promised a timely process. If FDA cannot deliver, then it makes sense to re-set the goals so as to make the next two years as certain, timely, and productive as possible.
As hard as it might be for Dr. Makary to do so, that discussion starts with FDA being truthful about the situation.
“Making things up” type of truths has gained a rather large foothold in DC over the last decade. Once its main adherent is gone, I like to think we will return to “barely true” as the historical floor for political and governmental discussions.
Discussed here: https://www.fdamatters.com/fdamatters/leaked-fy-26-fda-budget-document-explained
The document explicitly says the proposed budget authority (BA) appropriations will be sufficient to meet the maintenance of effort provisions in law that trigger FDA’s ability to collect user fees.
I want to emphasize that this pays for a robust process, not for any particular outcome. I feel strongly that this is legitimate and look forward to further offering my views on this when the renewal cycle gets started.