Presidential Transition Has Arrived at FDA: Some Q&A
Q: Do we know what comes next?
A: In a process sense, yes! We covered this in last week’s Analysis and Commentary here. Transition teams are being appointed that will assess FDA and provide recommendations to the incoming leadership. There is more detail on the process in the article.
As to substance, we are in the very early stages of transition and there are many unknowns.
While various newsletters are pontificating with possibilities, for the most part, people are relying on past statements that may not predict the Administration’s future actions.
Q: How many people will be on the FDA transition team? Are we likely to know their names?
A: There is a small window for transition teams to do their work and not a lot of time for coordinating. So, teams tend to be small and there is no specified number.
While some names may filter out, there may never be an official piece of paper naming the entire team.
Q: Are the campaign promises likely to stick?
A: One purpose of transition is for the teams to identify how campaign promises can be turned into reality. Overall, we can expect a more regulatory-reform tilt to most activities.
In an FDA-context, it can be hard to say which activities are pro-business. For example, an effort to end user fees would not be considered pro-business by the regulated industries. Some of the items reported to be of interest to Robert F. Kennedy, Jr. may be categorized more as libertarian or populist.
Q: When are we likely to start hearing the names of individuals being considered for FDA Commissioner?
A: In 2017, Dr. Gottlieb was nominated in March and confirmed in May. This is similar timing to Dr. Hamburg, who was the first FDA Commissioner in the Obama Administration. Their names only started to circulate in the new year.
I sense the second Trump administration may have a candidate ready sooner than these traditional timeframes. However, FBI clearances can add 4 to 5 weeks to the process, meaning a person quietly selected on February 1 might not be available to be nominated until March.
Q: What FDA challenges are independent of who won the election?
A: The FDA’s greatest challenges center around having the resources and support to maintain its global leadership position. Notably:
In an environment with pressure to cut budgets, FDA resource needs would be better served by evaluating individually, rather than be subject to across-the-board cuts that might affect agencies equally.
In an era of mis- and disinformation, FDA should maintain its standing as a global leader in both medical products and food safety by using sound science and law.
In the area of accelerating innovation and change, FDA should consider integrating AI, whole genome sequencing, bioscience invention, and similar cutting edge technology into the regulatory science that supports Agency decision-making.”
Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.