Recent developments include leadership changes, workforce reductions, and policy shifts at HHS and FDA, reshaping agency operations under President Trump’s administration.
Since his inauguration, President Trump has focused on reshaping federal agencies through a series of executive orders intended to reduce the size of the federal workforce and dramatically alter the landscape in which agencies operate. In turn, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and Food and Drug Administration (FDA) Commissioner Dr. Martin Makary have taken steps to significantly reshape policy at HHS and FDA.
In the latest installment of our We’ve Got Washington Covered series, our Healthcare & Life Sciences practitioners will examine changes at FDA since the start of the new administration, with a focus on their impacts on the agency’s review programs and enforcement priorities, as well as strategies for stakeholders navigating these recent developments, which include the following:
- Leadership changes. On February 13, 2025, the Senate confirmed Robert F. Kennedy, Jr. as HHS Secretary. On March 25, 2025, Dr. Makary was confirmed as FDA Commissioner, joining the agency during a period of transition. For example, Dr. Janet Woodcock, who served in the Office of the Commissioner and as Director of FDA’s Center for Drug Evaluation and Research for over two decades, and Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health for nearly 15 years, both retired from the agency in 2024. Dr. Peter Marks, who served as Director of the Center for Biologics Evaluation and Research for nearly a decade, also left the agency in March 2025.
- Reductions in force and staff departures. Since President Trump’s inauguration, there have been multiple efforts to reduce the size of the federal workforce, including at HHS and FDA. On February 11, 2025, President Trump issued an executive order directing agency heads to prepare to initiate large-scale reductions in force (RIFs) and for the Office of Management and Budget (OMB) to develop a plan to reduce the size of the federal workforce through hiring freezes and attrition. On March 27, 2025, HHS announced a RIF of about 10,000 full-time employees, with a 3,500 employee reduction at FDA. This RIF follows earlier efforts to reduce the number of full-time employees at FDA, including offering early retirement and deferred resignation programs, as well as terminations of employment for certain probationary workers at the agency.
- HHS reorganization. President Trump’s February 11, 2025 executive order on RIFs also directed agency heads to prepare “Agency Reorganization Plans” which “discuss whether the agency or any of its subcomponents should be eliminated or consolidated.” On March 27, 2025, HHS announced restructuring to “streamline [its] functions.” That announcement left open the possibility of further changes to HHS’s operations and structure as the administration continues its efforts to streamline the federal government. Previously, HHS’s Office of General Counsel consolidated regional offices while establishing a new Chief Counsel for Food, Research and Drugs, with supervisory authority over FDA’s Chief Counsel.
- President’s deregulatory and Make America Healthy Again agendas. President Trump and his administration also announced a series of actions to implement his deregulatory and Make America Healthy Again agendas.
On January 31, 2025, President Trump issued an executive order, “Unleashing Prosperity Through Deregulation,” which establishes a “regulatory cap” on both the number and cost of regulations. President Trump followed this with another executive order, “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative,” instructing federal agency heads to identify and classify regulations for review by the OMB for potential inconsistency with the law or the president’s agenda. OMB is then instructed to, in consultation with relevant agency heads, develop a Unified Agenda to rescind or modify such regulations. The executive order also instructs agency heads to engage in enforcement discretion with respect to “regulations that are based on anything other than the best reading of a statute” or which exceed constitutional authority. In response to the executive order, OMB published a request for information (RFI) from the public on “regulations that are unnecessary, unlawful, unduly burdensome, or unsound.” HHS and FDA then issued a separate RFI seeking “to identify and eliminate outdated or unnecessary regulations” or other guidance, memoranda, policy statements, or similar directives.
President Trump established a Make America Healthy Again Commission focused on the causes of certain chronic diseases and strategies to address them. The commission will include the OMB Director and FDA Commissioner, among others. As part of HHS’s announced reorganization, the department will create a new Administration for a Healthy America, consolidating agencies with a similar mission into a single office with HHS. Secretary Kennedy has directed FDA to take steps to implement this agenda, including by a directive to explore rulemaking to increase FDA oversight over food ingredients.
- Administration efforts to promote domestic medical production. On May 5, 2025, President Trump issued an executive order to facilitate domestic production of “critical medicines.” The executive order calls for FDA to “review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing and . . . take steps to eliminate any duplicative or unnecessary requirements in such regulations and guidance; maximize the timeliness and predictability of agency review; and streamline and accelerate the development of domestic pharmaceutical manufacturing.” The executive order also calls for FDA to evaluate its risk-based approach to preapproval and prelicensure inspections, including to “ensure[] routine reviews of overseas manufacturing facilities involved in the supply of United States medicines.”
- Change in rulemaking policy. On March 3, 2025, HHS issued a policy statement rescinding the so-called Richardson Waiver, a 1971 policy statement directing HHS offices and subagencies to engage in notice and comment rulemaking even in circumstances exempt from notice and comment requirements under the Administrative Procedure Act. By rescinding the Richardson Waiver, HHS expanded the circumstances under which it and its subagencies may issue rules without first providing a notice of proposed rulemaking and an opportunity for stakeholder comment. This sets the stage for HHS and FDA to potentially promulgate, rescind, or modify certain rules, including those implicating the president’s deregulatory agenda, more expeditiously than would have been possible under the Richardson Waiver.
Our forthcoming webcast as part of our We’ve Got Washington Covered series will examine these and other recent developments in greater detail.
