REGULATORY ROADMAP: Navigating FDA’s Shifting Landscape
With each new presidential administration comes a shift in regulatory priorities that can significantly impact the FDA and life sciences industry. Executive orders, policy directives, and agency guidance updates often set the tone for how drugs, medical devices, and biologics are regulated, influencing everything from approval pathways to compliance expectations.
The first 100 days of a new Administration are often seen as a benchmark – though largely symbolic – of an incoming president’s early momentum and priorities. Since taking office on January 20, 2025, President Trump has moved swiftly, leveraging executive authority to enact policy changes and set the tone for his administration’s agenda.
With early policy actions already shaping the landscape, ELIQUENT Life Sciences is actively monitoring developments to assess potential impacts and emerging trends. In this blog series, we’ll explore how these developments may affect the life sciences industry and what organizations should anticipate in the months ahead.
Leadership Shifts
As with any new presidential administration, leadership transitions occur as new appointees undergo Senate confirmation. Typically, department heads are confirmed first, followed by agency leadership appointments. This pattern continues in 2025, with the HHS Secretary’s confirmation hearings taking place this week, setting the stage for subsequent agency leadership changes.
Department of Health & Human Services (HHS)
Dorothy Fink, MD, has been named acting Secretary of Health and Human Services, pending confirmation of Robert F. Kennedy, Jr, President Trump’s permanent pick for the position. Kennedy’s Senate confirmation hearings are ongoing.
U.S. Food & Drug Administration (FDA)
Sara Brenner, MD, MPH, is the acting Commissioner of Food and Drugs, pending confirmation of Trump nominee Martin Makary, MD, MPH. Dr. Makary’s confirmation hearing has not yet been scheduled. Key staff acting or expecting leadership roles at FDA include: James Traficant (Chief of Staff), James Lawrence (Chief Counsel), Ritu Nalubola (Acting Deputy Commissioner of Policy, Legislation, and International Affairs), and Heidi Rebello (Acting Associate Commissioner for External Affairs).
Executive Orders Applicable to the FDA
Dozens of Executive Orders (EOs) have been signed by President Trump, demonstrating an abrupt shift in policy from the Biden Administration. EOs have the force of law, much like federal regulations issued by executive agencies, but some of the recent Trump EOs may be (or have been) subject to legal challenge
To date, we are tracking the following EO with an immediate or potential impact on FDA:
Regulatory Freeze and Related Halt to FDA Public Communications
EO Overview: Prohibits promulgating new rules until a new Department/Agency head is appointed and approves the rule. In addition, requires unpublished rules at the Federal Register to be pulled back, and recommends a 60-day postponement of effective dates for any rules published in the Federal Register but not currently in effect. [LINK]
Impact: Most new administrations implement a regulatory freeze until new political leadership is in place. However, the EO from President Trump appears to extend beyond a typical pause. Acting HHS Secretary Fink issued a memo implementing the freeze, which included a halt to public communications from HHS.
The temporary halt to communications appears to expire on February 1 and may exempt communications that are “required by law or because they’re critical for health, safety or other reasons.”
Our initial understanding is that this memo is not intended to impact any activities related to medical product reviews or decisions on applications that affect individual companies.
Hiring Freeze and OMB “Deferred Resignation” Email
EO Overview: Freezes hiring for federal civilian positions that are vacant as of January 20, 2025, and prohibits the creation of new positions, with limited exceptions. The EO expires in 90 days with the submission from OMB of a “plan to reduce the size of the Federal Government’s workforce through efficiency improvements and attrition.” [LINK]
In addition to the hiring freeze, earlier this week OMB sent an email, reportedly to all federal employees, offering each employee the option to either: (1) continue in their current position and agree to follow the newly announced “four pillars” of the federal work force (but with no guarantee of continued employment); or (2) resign by February 6, with full pay and benefits available through September 30, 2025, which permits the employee to be exempt from return to in person work mandates. [LINK]
Impact: Similar to regulatory freezes, many new administrations implement a temporary hiring freeze until new political leadership is established. President Trump’s EO, however, does not expire until OMB submits its plan to reduce the size of the government, signaling Trump’s seriousness in cutting government costs and creating efficiencies, particularly considering the OMB email.
In the short term, the hiring freeze should not impact day-to-day operations at FDA, but if it extends for a longer period of time and/or a significant number of FDA employees take advantage of OMB’s deferred resignation offer, there could be delays in product review times, enforcement efforts, and other agency actions.
Other Workforce Related EOs
- Return to In-Person Work [LINK]
- Ending Radical And Wasteful Government DEI Programs And Preferencing [LINK]
- Restoring Accountability To Policy-Influencing Positions Within the Federal Workforce [LINK]
EO Overview: President Trump issued several EOs related to the federal workforce, including a return to in-person work mandate “as soon as practicable”; a directive to OMB to terminate all current DEI “mandates, policies, programs, preferences, and activities in the Federal Government, under whatever name they appear”, within 60 days; and implementing the so-called “Schedule F” designations and other related actions that make it easier to remove federal (civilian) employees who fail to “faithfully implement administration policies to the best of their ability, consistent with their constitutional oath and the vesting of executive authority solely in the President.”
Consistent with Trump’s campaign promises, and the creation of the Department of Government Efficiency (DOGE), these orders appear to be designed to slim down the federal workforce and eliminate certain employees who are not aligned with the new administration’s policies.
Impact: Space constraints at White Oak could make return to work orders difficult to implement and may allow FDA to argue for exemptions, but to the extent all three of these EOs are successful in forcing attrition, FDA would lose a significant number of critical, and irreplaceable, scientific and other staff who have been hired as full time remote employees, who are converted to schedule F, or who fall under DEI programs. We are also concerned that the DEI EO could impact clinical trial diversity efforts, including a draft guidance FDA issued on the topic recently.
WHO Withdrawal:
EO Overview: Formally withdraws the US from the WHO, immediately ceasing any federal funding for the WHO and reassigning any federal employees currently conducting any work with WHO.
Impact: This will have a direct impact on FDA, CDC, and NIH staff involved with WHO activities, particularly with respect to responding to global pandemics and infectious diseases as well as medical product supply chain information, among other public health ramifications.
It may have longer terms consequences for medical product supply chains and for the credibility of the U.S. as a leader in public health.
Stay Informed
As the new administration continues to shape its leadership and policy direction, the impact on the FDA and the broader life sciences industry will become clearer. Staying informed and proactive will be key for organizations navigating these changes.
This blog is part of an ongoing series, and we will continue to provide updates as new appointments are confirmed and regulatory priorities take shape. Stay tuned for future insights on how these transitions may affect regulatory strategy, compliance, and market access in the months ahead.
For those who would like to discuss these changes in more detail, reach-out to our authors:
Kalah Auchincloss: kauchincloss@eliquent.com
Brian Mayhew: bmayhew@eliquent.com
Ready for Regulatory Clarity?
Stay informed as the regulatory landscape evolves. Subscribe to our blog to receive the latest updates on policy changes, FDA developments, and their impact on the life sciences industry.