Experts: Trump executive orders create foundation for what’s to come

President Donald Trump wasted no time this week launching his agenda for the federal government, issuing scores of executive orders and directives from the White House, including some that affect how US health agencies communicate with the public, conduct hiring, and address public health issues.

Elizabeth Halpern, a partner at Hogan Lovells, noted that the executive order on federal return to office was not surprising, but fulfills a campaign promise.

"We'll have to see what effect that has probably over the longer term as far as whether federal employees, the people we work with most at the agencies we deal with, will want to stay in their jobs with that in place," said Halpern.

Philip Desjardins, a partner at Arnold & Porter and a former policy director at FDA Center for Devices and Radiological Health (CDRH), told Focus that the agency has significantly ramped up its workforce over the past 15 years and intentionally hired people for fully remote positions outside of the Washington metropolitan area to meet its needs. Requiring staff to work from FDA’s White Oak headquarters, or even regional offices or duty stations, creates significant logistical challenges, he said.

Desjardins said the White Oak headquarters was not configured to handle the size of the current FDA workforce, especially when you factor in the Center for Tobacco Products, which did not exist when FDA moved into its current campus. Further, various user fee programs require the FDA to hire staff to fulfill requirements agreed upon by regulated industries and the agency. He noted that every user fee program has expanded significantly over the past three cycles, with most of the funding allotted to new staff. Requiring them to come into the office could create logistical challenges and lost productivity.

"I'm aware of FDA employees who have relocated over the course of the last five years with full transparency and visibility to FDA leadership. Those individuals have established lives outside of the DC metropolitan area, and are subject matter experts, and have critical roles in the day-to-day business of what FDA does," said Desjardins.

"If an employee relocated to Florida in 2021 and has been actively doing their role and is being told they have two options, one is to relocate back to the DC area or ... some facility somewhere in Florida that still happens to be two hours away from their home, that individual is going to be forced with the decision where it might not be logistically feasible or worthwhile for them to relocate," he said. "I think that is likely going to have an impact on a number of FDA staff voluntarily resigning rather than coming back into compliance with the new directive of a physical presence.”

Political appointments, withdrawing from WHO

Trump also issued an executive order arguing that Article II of the US Constitution grants the president the authority to remove senior executive service (SES) employees who wield significant governmental authority to ensure the faithful execution of his policies and goals. An additional order reclassifies certain career civil servants as “Schedule Policy/Service” employees and gives the president more authority to fire them, again for the purpose of ensuring his agenda. Halpern noted that the order is like one Trump issued at the end of his last presidency (creating Schedule F) to politically appoint executive-level employees who he deemed would more faithfully execute his policies.

“The overall message of it, as kind of clearly laid out, is that the Trump administration is looking at changing the criteria used to hire and retain [certain] federal employees,” said Halpern. “We'll have to see how that actually gets implemented.

“What that means is going to be different across every agency because they each have their own unique personnel structure,” she added.

Halpern pointed out that executive orders generally don't change statutes but rather give instructions to agencies to potentially consider developing different regulations or change regulations, or they state the president’s preference for a law or how it is interpreted. She also noted that the wording of many executive orders reiterate Trump's policies to reduce regulatory burdens during his first term. She pointed out that he campaigned on withdrawing old regulations before instituting new ones but added that a lot of regulations are bundled, which complicates the situation.

For example, Halpern said the executive order to withdraw the US from the World Health Organization would take a long time to implement. While that process unwinds, Congress and federal agencies may conduct their own analyses of how the withdrawal will affect the US.

"This was only the beginning. There are many, many more things to come, and we also still have a lot of confirmation hearings ahead of us, which could affect the timing and order in which things happen," said Halpern. "[The question is] would they want to wait on issuing some of the executive orders until their leadership is in place, or in some cases, maybe do them sooner in the hopes that things could get done even without new secretaries and administrators in office."

Communication blackout

The Trump administration also issued a memo to federal health agencies, including the US Food and Drug Administration (FDA), to temporarily pause external communications. Throughout the week, Focus has reached out to several offices at FDA and the Department of Health and Human Services (HHS) for information about the new administration’s policies but has repeatedly received the following boilerplate response:

“HHS has issued a pause on mass communications and public appearances that are not directly related to emergencies or critical to preserving health. This is a short pause to allow the new team to set up a process for review and prioritization. There are exceptions for announcements that HHS divisions believe are mission critical, but they will be made on a case-by-case basis.”

Desjardins said that he agrees with Halpern that the executive orders are not surprising and may not have a direct impact on FDA's ability to do its job but rather set up the Trump administration to carry out its future objectives.

However, the directive to pause communications raises questions about the potential short-, medium-, and long-term impacts of that decision, he said, adding that he questions whether the agency currently has the ability to respond quickly to such issues. He also noted that the FDA publishes a lot of day-to-day notices on product approvals, recalls, enforcement reports, and more upon which stakeholders rely. If those do not resume soon, it could have negative impacts on how they do business.

"Let's use devices as an example. If it is a two-week pause on communicating information and updating FDA's website, it's probably not that big of an impact," said Desjardins. "But if it's a two-month pause, and if I'm company A and I'm relying on one of my competitors that got cleared or [authorized] through the de novo process in the last two weeks, and then I'm going to be a fast follower, and I'm going to supplement their clearance or their approval and leveraging them as a predicate, now I'm not getting that summary of safety and effectiveness. I'm not getting that awareness that FDA cleared or approved or granted the de novo order in a timely fashion, and it may have an immediate and direct impact on my ability to file my own submission with the agency.

“If I'm two months delayed in filing with the agency, I'm also two months delayed in launching my product and generating the associated revenue,” he added.

Desjardins noted that it’s not uncommon for a new administration or commissioner to pause communications, policies, and guidances for weeks or even months. However, he said the way the Trump administration announced the pause was unprecedented.

“The transparency of how public that statement was is not something I've seen before,” said Desjardins. “The breadth and scope of this particular pause, I think, is different than I've seen, at least in the last two or three administration changes."

Ending DEI initiatives

Trump also ordered federal agencies to end all diversity, equity, inclusion, and accessibility (DEIA) programs and contracts, direct all federal agencies to put diversity, equity, and inclusion (DEI) employees on paid leave, and direct staff to report colleagues who defy the order.

“We are aware of efforts by some in government to disguise these programs by using coded or imprecise language,” said Scott Rowell, deputy chief of staff at the Department of Health and Human Services (HHS), in an email to employees where he said that staff should report such actions to the Office of Personnel Management (OPM).

“There will be no adverse consequences for timely reporting this information,” he added. “However, failure to report this information within 10 days may result in adverse consequences.”

FDA also removed from its website several potentially DEI-related draft guidances mandated by the 2022 Food and Drug Omnibus Reform Act (FDORA), including one on clinical trial diversity action plans, another on evaluating sex-specific and gender-specific data in medical device clinical studies, and new a draft guidance on standards for collecting race and ethnicity data in clinical trials (RELATED: FDA issues diversity action plan draft guidance, Regulatory Focus, 26 June 2024; FDA proposes to modernize guidance on sex, gender in clinical trials, Regulatory Focus, 14 January 2025; Clinical trials: FDA proposes new standards for collecting race, ethnicity data, Regulatory Focus, 30 January 2024).

Desjardins said he was surprised that the draft guidances were removed from the FDA’s website but said that there is a critical underlying need for sub-population data for some medical products to ensure their safety and effectiveness.

Nixing Biden AI executive order

Trump also revoked Biden’s executive order outlining the federal government’s thinking on artificial intelligence (AI). Desjardins said revoking that order created a vacuum on the executive level regarding how the US government thinks about the technology.

"I do not believe that that would impact any of the FDA-specific guidance documents or policies that are in place today, but it does create the need for, or at least a vacuum around, how should all government organizations be thinking about this," he said. "I would anticipate that the new administration has a perspective on AI and the appropriate regulation of AI across the government.”

Trump executive orders

Experts: Trump executive orders create foundation for what’s to come

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