Keep Calm and Carry On: Lessons from Trump 1.0
Eight years ago, the first Trump Administration (Trump 1.0), came into office with the stated intent of reducing regulation, shrinking the federal workforce, and cutting agency budgets.
They were quick out of the gates with their plans. For the most part, FDA was not specifically targeted, but many (if not most) of the proposals would have impacted the agency. Understandably, it created a lot of concern among agency employees and stakeholders.
A few days into the new Administration (Trump 2.0), it has become clear that objectives are the same, albeit rolled into the rubric of “less government.” What we are seeing—compared to 2017--is more executive orders and directives that are 1/ conceptualized with greater sophistication and 2/ being expressed with more urgency and determination.
Even still, I am experiencing a strong sense of déjà vu rather than some wholly new sense of peril for FDA. Although the ultimate outcomes in 2025 may be quite different—even quite a bit worse-- the challenges are mostly ones FDA has seen before in 2017 and in the later years of Trump 1.0.
In 2017, President Trump ordered a freeze on new regulations. This morphed into a requirement that agencies “eliminate two regs for every new one.” Eventually, it led to the realization that, in most cases, regulations could only be eliminated through the time-consuming “notice and comment rulemaking” process.
The President also announced a hiring freeze for 90 days at the beginning of 2017. This was intended to be a bridge to an OMB plan to place “a hiring freeze on all federal employees to reduce the federal workforce through attrition (exempting military, public safety, and public health).” A long-term or permanent hiring freeze would have had a disproportionate impact on FDA, which was trying to fill upwards of a thousand vacancies at the time.
Later into Trump 1.0, his Administration developed the so-called “Schedule F,” a plan to replace a large swath of senior policy positions into political appointees (analysis here). The plan was promulgated in October 2020, then withdrawn by President Biden soon after taking office.
We are only a few days into Trump 2.0, but we can already see many of the parallels.
Reducing the federal workforce—in terms of both size and influence—is clearly a top priority. This is, of course, of particular concern to FDA—with its large, well-educated, and multi-skilled workforce. About 80% of FDA’s budget pays for people-related costs (salary, benefits, rent, IT, training, etc.).
Among other things, a hiring freeze has been put in place. Special attention is being given to the potential to reduce head count by eliminating new and probationary employees and targeting those working on diversity, equity, and inclusion programs.
Return to office (RTO) policies have been put in place for federal workers and the first steps have been taken to reinstall Schedule F (here). On the latter, the National Treasury Employees Union (which represents the FDA workforce) has already filed suit to block its implementation.
Other initiatives announced this week include big picture items (such as withdrawing from the World Health Organizations) and small, presumably temporal ones (within HHS, cancelling public meetings and external communications through February 1).
From watching OMB and FDA interpret these types of executive orders and directives in 2017, I learned there is a lack of clarity when they are first announced. Whether and how much FDA would be affected requires reading the fine print—in the overall declaration and then how it is to be applied to the massive responsibilities, different personnel systems, multiple funding sources, and wide range of skills needed at FDA.
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.
In the meantime, I urge everyone to “keep calm and carry on.”
READ Steven’s last column, “Down is Good and Up is Bad: Or is It the Other Way Around?”
PODCAST ALERT: Available Now at https://lnkd.in/e26EjEkn Shelly Garg and Wayne Pines sit down with Marc Scheineson and Steven Grossman to discuss the FDA in transition.
WEBINAR ALERT: Friday, January 31 · 11am - 12:30pm EST Register Here
“8th Annual Wow! or Yeow!?: A Review of FDA in 2024 and Predictions for 2025.” Steven will be part of a panel discussion along with Janet Woodcock, Alexander Fleming, Frank Sasinowski, Kate Rawson Powell, and others.
RECOMMENDED READING: “What the Trump Administration Shouldn’t Change About the FDA” by Stuart Pape, Wayne Pines, and Mitch Zeller https://www.statnews.com/2025/01/21/fda-trump-nominees-rfk-jr-marty-makary-confirmation-hearings/
Steven was quoted in AP story this week, which appeared in Washington Post, ABC 7, STAT, and Al Jazerra
About the author: Steven Grossman is the author of “FDA Matters: The Grossman FDA Report.” For additional commentary about FDA issues sign up to receive Grossman’s weekly columns at www.fdamatters.com.