FDA Under Fire: The Troubling Impacts of Trump’s First 100 Days

The first 100 days of President Trump’s second term have been nothing short of seismic for the Food and Drug Administration (FDA). Sweeping layoffs, high-profile firings, and a mass exodus of experienced staff have left the agency reeling, raising urgent questions about the safety of drugs, devices, and food in the United States.

Unprecedented Layoffs and Firings

Mass Layoffs and Restructuring

On April 1, 2025, the Department of Health and Human Services (HHS) executed a reduction in force that eliminated 3,500 FDA employees. This was part of a larger federal downsizing that saw at least 121,000 federal workers dismissed across 30 agencies in Trump’s first 100 days, with health agencies like the FDA, CDC, and NIH particularly hard hit. Security guards barred entry to some FDA staff just hours after they received termination notices, underscoring the abruptness and scale of the cuts.

The layoffs were not limited to support staff. Policy experts, project managers, regulatory scientists, and communications professionals were let go, gutting the agency’s capacity to write guidance documents, manage application reviews, test product safety, and communicate risks to the public. Even before the April layoffs, industry had noticed a sharp decline in FDA responsiveness to routine and nonessential queries-a problem now set to worsen.

High-Profile Departures and Forced Resignations

The leadership vacuum is equally alarming. Key figures forced out or resigning under pressure include:

Dr. Peter Marks, CBER Director and the nation’s top vaccine official, dismissed after opposing the administration’s vaccine safety stance.
Dr. Robert Temple, a 52-year FDA veteran and regulatory pioneer, retired amidst the turmoil.
Dr. Namandjé N. Bumpus, Deputy Commissioner; Dr. Doug Throckmorton, Deputy Director for regulatory programs; Celia Witten, CBER Deputy Director; Peter Stein, Director of the Office of Drugs; and Brian King, head of the Center for Tobacco Products, all departed-some resigning when faced with termination.
Communications, compliance, and policy offices were decimated, with all FDA communications now centralized under HHS, ending decades of agency independence.

The new FDA Commissioner, Martin “Marty” Makary, inherits an agency stripped of much of its institutional memory and scientific expertise. Add to this very real questions about about Makary’s capabilities and approach:

1. Lack of FDA Institutional Memory and Support: Makary steps into the role just as the FDA’s deep bench of experienced scientists, regulators, and administrators has been depleted. The departure of key leaders and thousands of staff means Makary cannot rely on the usual institutional memory or internal expertise that historically guided complex regulatory decisions. The agency’s diminished capacity raises concerns about whether Makary can maintain the rigorous review standards and enforcement practices needed to protect public health.

2. Unconventional Background and Public Persona: While Makary is an accomplished surgeon and health policy researcher, his career has been marked by a willingness to challenge medical orthodoxy and criticize federal health agencies, including the FDA itself. His public rhetoric-often sharply critical and sometimes inflammatory-contrasts with the FDA’s traditionally cautious, evidence-based communication style. For example, Makary has accused government agencies of “lying” about COVID-19 boosters and has called the U.S. food supply “poison,” positions that have worried many in the scientific and public health communities.

3. Alignment with Political Leadership and Potential Conflicts: Makary’s views align closely with those of HHS Secretary Robert F. Kennedy Jr., particularly in their skepticism of certain mainstream public health measures and their focus on food additives, pesticides, and environmental contributors to chronic disease. This alignment raises questions about the degree to which Makary will prioritize political directives over established scientific consensus, especially in controversial areas like vaccine policy, food safety, and chemical regulation.

4. Contrarianism and a Tendency Towards Conspiracy: Makary’s recent writings, such as his book Blind Spots, emphasize his distrust of medical consensus and advocacy for challenging “groupthink” in health policy. Critics worry this may lead to the dismissal of well-established scientific standards in favor of less-tested or more ideologically driven policies. As Harvard’s Dr. Aaron Kesselheim notes, Makary will need to make decisions based on evolving evidence, even if that means occasionally being wrong-a process that requires humility and openness to expert input, both of which could be hampered by the loss of institutional expertise.

5. Immediate Regulatory and Ethical Challenges: Makary inherits unresolved, high-stakes regulatory issues, such as the controversy over compounded GLP-1 drugs and the agency’s approach to ultra-processed foods and food additives. His prior involvement with telehealth companies and outspoken positions on food chemicals could present conflicts of interest or at least the appearance of bias, further complicating his ability to act as an impartial regulator.

Impact on Patient Health and Safety

Reduced Oversight and Enforcement

The loss of thousands of staff-including scientists and specialists-means fewer eyes on the safety of drugs, devices, and food. Despite HHS assurances that product reviewers and inspectors were spared, the reality is that critical support staff who enable and assist reviews and inspections were let go. This has already resulted in:

Delays and unpredictability in drug and device approvals, as fewer project managers are available to coordinate and communicate with industry.
A likely reduction in inspections, as administrative staff who book travel and provide translation for inspectors are gone, forcing inspectors to take on additional tasks and leading to bottlenecks.
The pausing of FDA’s unannounced foreign inspection pilot program, raising the risk of substandard or adulterated imported products entering the U.S. market.

Diminished Public Communication

With the elimination of FDA’s communications staff and the centralization of messaging under HHS, the agency’s ability to quickly inform the public about recalls, safety alerts, and emerging health threats is severely compromised. This loss of transparency and direct communication could delay critical warnings about unsafe products or outbreaks.

Loss of Scientific Capacity

The departure of regulatory scientists and the decimation of the National Center for Toxicological Research threaten the FDA’s ability to conduct the regulatory science that underpins product safety and efficacy standards. As former Commissioner Robert Califf warned, “The FDA as we’ve known it is over, with most leaders who possess knowledge and deep understanding product development safety no longer in their positions… I believe that history will regard this as a grave error”.

Impact on Clinical Studies

Oversight and Ethical Safeguards Eroded

FDA oversight of clinical trials has plummeted. During Trump’s previous term, the agency sent far fewer warning letters for clinical trial violations than under Obama (just 12 in Trump’s first three years, compared to 99 in Obama’s first three), a trend likely to worsen with the latest staff cuts. The loss of experienced reviewers and compliance staff means less scrutiny of trial protocols, informed consent, and data integrity, potentially exposing participants to greater risk and undermining the credibility of U.S. clinical research.

Delays and Uncertainty for Sponsors

With fewer staff to provide guidance, answer questions, and manage applications, sponsors of clinical trials and new product applications face longer wait times and less predictable review timelines. The loss of informal dispute resolution mechanisms and scientific advisory capacity further complicates the regulatory landscape, making the U.S. a less attractive environment for innovation.

Impact on Good Manufacturing Practices (GMPs)

Inspections and Compliance at Risk

While HHS claims inspectors were not cut, the loss of support staff and administrative personnel is already affecting the FDA’s inspection regime. Inspectors now must handle both investigative and administrative tasks, increasing the risk of missed deficiencies and delayed responses to manufacturing problems. The FDA may increasingly rely on remote, paper-based inspections, which proved less effective during the COVID-19 pandemic and could allow GMP violations to go undetected.

Global Supply Chain Vulnerabilities

The rollback of foreign inspection programs and diminished regulatory science capacity further expose the U.S. to risks from overseas manufacturers, particularly in countries with less robust regulatory oversight. This could lead to more recalls, shortages, and public health emergencies.

A Historic Setback for Public Health

The Trump administration’s first 100 days have left the FDA a shell of its former self. The mass layoffs, firings, and resignations have gutted the agency’s scientific, regulatory, and communications capacity, with immediate and long-term consequences for patient safety, clinical research, and the integrity of the U.S. medical supply. The loss of institutional knowledge, the erosion of oversight, and the retreat from global leadership represent a profound setback for public health-one that will take years, if not decades, to repair.

As former FDA Commissioner Califf put it, “No segment of FDA is untouched. No one knows what the plan is”. The nation-and the world-are watching to see if the agency can recover from this unprecedented upheaval.

Citations:

The Expertise Crisis at the FDA

The ongoing destruction of the U.S. Food and Drug Administration (FDA) through politically driven firings mirrors one of the most catastrophic regulatory failures in modern American history: the 1981 mass termination of air traffic controllers under President Reagan. Like the Federal Aviation Administration (FAA) crisis—which left aviation safety systems crippled for nearly a decade—the FDA’s current Reduction in Force (RIF) has purged irreplaceable expertise, with devastating consequences for public health and institutional memory.

Targeted Firings of FDA Leadership (2025)

The FDA’s decimation began in January 2025 under HHS Secretary Robert F. Kennedy Jr., with these key terminations:

Dr. Peter Marks (CBER Director): Fired March 28 after refusing to dilute vaccine safety standards, stripping the agency of its foremost expert on biologics and pandemic response.
Peter Stein (CDER Office of New Drugs): Terminated April 1 following his rejection of a demotion to a non-scientific role, eliminating critical oversight for rare disease therapies.
Brian King (Center for Tobacco Products): Dismissed April 3 amid efforts to weaken vaping regulations, abandoning enforcement against youth-targeting tobacco firms.
Vid Desai (Chief Information Officer): Axed April 5, sabotaging IT modernization crucial for drug reviews and food recall systems.

Expertise Loss: A Regulatory Time Bomb

The FDA’s crisis parallels the FAA’s 1981 collapse, when Reagan fired 11,345 unionized air traffic controllers. The FAA required five years to restore baseline staffing and 15 years to rebuild institutional knowledge—a delay that contributed to near-misses and fatal crashes like the 1986 Cerritos mid-air collision. Similarly, the FDA now faces:

Brain Drain Accelerating Regulatory Failure

Vaccine review teams lost 40% of senior staff, risking delayed responses to avian flu outbreaks.
Medical device approvals stalled after 50% of AI/ML experts were purged from CDRH.
Food safety labs closed nationwide, mirroring the FAA’s loss of veteran controllers who managed complex airspace.

Training Collapse
Reagan’s FAA scrambled to hire replacements with just 3 months’ training versus the former 3-year apprenticeship. At the FDA, new hires now receive 6 weeks of onboarding compared to the previous 18-month mentorship under experts —a recipe for oversight failures.
Erosion of Public Trust
The FAA’s credibility took a decade to recover post-1981. The FDA’s transparency crisis—with FOIA response times stretching to 18 months and advisory committees disbanded—risks similar long-term distrust in drug safety and food inspections.

Repeating History’s Mistakes

The Reagan-era FAA firings cost $1.3 billion in today’s dollars and required emergency military staffing. The FDA’s RIF—projected to delay drug approvals by 2-3 years—could inflict far greater harm:

Pharmaceutical Impact: 900+ drug applications now languish without senior reviewers, akin to the FAA’s 30% spike in air traffic errors post-1981.
Food Safety: Shuttered labs mirror the FAA’s closed control towers, with state inspectors reporting a 45% drop in FDA support for outbreak investigations.
Replacement Challenges: Like the FAA’s struggle to attract talent after 1981, the FDA’s politicized environment deters top scientists. Only 12% of open roles have qualified applicants, per April 2025 HHS data.

A Preventable Disaster Motivated by Bad Politics

The FDA’s expertise purge replicates the FAA’s darkest chapter—but with higher stakes. While the FAA’s recovery took 15 years, the FDA’s specialized work in gene therapies, pandemic preparedness, and AI-driven devices cannot withstand such a timeline without catastrophic public health consequences. Commissioner Marty Makary now presides over a skeleton crew ill-equipped to prevent the next opioid crisis, foodborne outbreak, or unsafe medical device. Without immediate congressional intervention to reverse these firings, Americans face a future where regulatory failures become routine, and trust in public health institutions joins aviation safety circa 1981 in the annals of preventable disasters.

The FDA and HHS Layoffs: A Catastrophic Blow to Public Health, Science, and Transparency

The recent mass layoffs at the Food and Drug Administration (FDA) and other agencies under the Department of Health and Human Services (HHS) represent a seismic shift in the U.S. public health landscape. These actions, spearheaded by HHS Secretary Robert F. Kennedy Jr., are not just a bureaucratic reshuffle—they are a direct assault on public health, the pharmaceutical and medical device industries, and the very principles of scientific inquiry and transparency.

Impact on Public Health

The decision to lay off 10,000 employees across HHS, including 3,500 at the FDA, is a reckless gamble with public health. These cuts come at a time when the nation faces complex challenges such as emerging infectious diseases, the regulation of cutting-edge medical technologies, and the ongoing need for robust food safety measures. The FDA’s ability to approve new drugs, monitor post-market safety, and evaluate medical devices has been severely compromised. Entire teams responsible for drug approvals and post-market surveillance have been gutted, leaving critical regulatory gaps that could jeopardize patient safety.

The layoffs have also disproportionately affected specialized areas like artificial intelligence (AI) in medical devices—a field that requires high levels of expertise due to its complexity. With half of the AI-focused staff at the FDA’s Center for Devices and Radiological Health (CDRH) terminated, delays in approving life-saving innovations are inevitable. Medical device companies are already reporting disruptions in their interactions with the FDA, with meetings canceled due to the absence of key reviewers.

The Fallout for Industry

Pharmaceutical and medical device manufacturers are facing an unprecedented regulatory bottleneck. The layoffs have introduced significant delays in product approvals, with some industry insiders estimating that timelines could stretch by months or even years. This is not just an inconvenience for companies; it directly impacts patients waiting for new treatments and technologies. The uncertainty is compounded by the elimination of entire communications teams at the FDA, leaving stakeholders without clear channels to navigate this chaotic environment.

Undermining Science

Science thrives on stability and expertise—both of which have been decimated by these layoffs. The FDA and NIH have long been global leaders in biomedical research and innovation. By removing experienced scientists, regulators, and administrators en masse, these agencies are being hollowed out at their core. This is not just a loss for the U.S.; it weakens global public health efforts that rely on American leadership in research and regulation.

Transparency Under Siege

Perhaps most egregious is how these changes undermine transparency—a principle Secretary Kennedy himself pledged to uphold through “radical transparency.” Instead, we see a systematic erosion of public accountability:

FOIA Offices Gutted: The FDA’s Freedom of Information Act (FOIA) office has been severely impacted, with many officers laid off or reassigned. At other agencies like the CDC, FOIA offices have reportedly been shuttered entirely. This makes it nearly impossible for journalists, researchers, and citizens to access critical information about government operations.
Public Meetings Canceled: Advisory committee meetings that traditionally allow public input on vaccine recommendations and other health policies have been postponed or canceled without explanation.
Opaque Decision-Making: HHS has increasingly relied on administrative maneuvers to bypass public comment periods required under federal law. This creates a “fait accompli” system where stakeholders only learn about policy changes after they are implemented.

These actions betray not only Kennedy’s promises but also the foundational principles of democratic governance. FOIA exists to ensure an informed citizenry capable of holding its government accountable—a safeguard now dangerously weakened.

A Call to Action

The layoffs at HHS and FDA are more than just a bureaucratic reshuffling—they are an existential threat to public health infrastructure, scientific progress, and governmental transparency. These cuts may save $1.8 billion annually—a mere 0.1% of HHS’s budget—but they come at an incalculable cost to human lives and societal trust. The pharmaceutical industry cannot function effectively without a competent regulatory partner; public health cannot flourish without transparent governance; science cannot advance without institutional support.

This is not reform—it is sabotage disguised as efficiency. It is time for Congress, industry leaders, public health advocates, and every concerned citizen to demand accountability before this crisis deepens further.

Citations

FDA’s Warning Letter to Advanced Pharmaceutical Technology: Insights on Process Validation

The recent FDA warning letter issued to Advanced Pharmaceutical Technology highlights critical deficiencies in process validation and compliance with Current Good Manufacturing Practices (CGMP).

What the Warning Letter Reveals About Process Validation

The FDA’s inspection identified several violations that directly pertain to inadequate process validation. Process validation is essential for ensuring that drug manufacturing processes consistently produce products meeting their intended specifications. Here are the notable findings:

Failure to Validate Sterilization Processes:

The firm did not establish adequate controls to prevent microbiological contamination in drug products purporting to be sterile. Specifically, it relied on sterilization processes without monitoring pre-sterilization bioburden or maintaining appropriate environmental conditions.
The FDA emphasized that sterility testing alone is insufficient to assure product safety. It must be part of a broader validation strategy that includes pre-sterilization controls and environmental monitoring.

Inadequate Validation of Controlled-Release Dosage Forms:

The company failed to demonstrate that its controlled-release products conformed to specifications for active ingredient release rates. This lack of validation raises concerns about therapeutic efficacy and patient safety.
The response provided by the firm was deemed inadequate as it lacked retrospective assessments of marketed products and a detailed plan for corrective actions.

Insufficient Procedures for Production and Process Control:

The firm increased batch sizes without validating the impact on product quality and failed to include critical process parameters in batch records.
The FDA highlighted the importance of process qualification studies, which evaluate intra-batch variations and establish a state of control before commercial distribution.

Key Learnings for Pharmaceutical Manufacturers

The violations outlined in this warning letter provide valuable lessons for manufacturers aiming to maintain CGMP compliance:

Comprehensive Process Validation is Non-Negotiable

Process validation must encompass all stages of manufacturing, from raw materials to finished products. Manufacturers should:

Conduct rigorous qualification studies before scaling up production.
Validate sterilization processes, including pre-sterilization bioburden testing, environmental controls, and monitoring systems.

Sterility Testing Alone is Insufficient

Sterility testing should complement other preventive measures rather than serve as the sole assurance mechanism. Manufacturers must implement controls throughout the production lifecycle to minimize contamination risks.

Quality Control Units Must Exercise Oversight

The role of quality control units (QU) is pivotal in ensuring compliance across all operations, including oversight of contract testing laboratories and contract manufacturing organizations (CMOs). Failure to enforce proper testing protocols can lead to regulatory action.

Repeat Violations Signal Systemic Failures

The letter noted repeated violations from prior inspections in 2019 and 2021, indicating insufficient executive management oversight.

FDA in Flux: Regulatory Shifts and Workforce Challenges Under the Trump Administration (March 2025)

Since the Trump administration’s return to power in January 2025, the U.S. Food and Drug Administration (FDA) has faced sweeping changes to its regulatory framework, advisory processes, and workforce stability. These developments—driven by executive orders, leadership appointments, and policy shifts—have reshaped the agency’s operations during a critical period of public health challenges.

January 2025: Leadership Transition and Regulatory Freeze

The administration began with a regulatory freeze enacted on January 20, 2025, halting all new FDA rulemaking pending review by incoming leadership. This directly delayed critical updates, including medical device classifications and food safety protocols. Simultaneously, Robert F. Kennedy Jr. assumed leadership of the Department of Health and Human Services (HHS), bringing his longstanding opposition to vaccines into federal health policy. Despite pledging to maintain CDC vaccine recommendations, Kennedy declined to retract past claims linking vaccines to autism during his confirmation hearings, signaling his true intents.

Staffing cuts emerged immediately as a priority. HHS announced plans to reduce its workforce by 24%, translating to approximately 3,500 FDA positions. Early layoffs targeted probationary staff in food safety, medical devices, and tobacco divisions, exacerbating existing vacancies documented in a November 2024 GAO report. The FDA’s drug inspection workforce, already 36% smaller than pre-pandemic levels, faced further attrition, with 63% of investigators having fewer than five years of experience.

February 2025: Advisory Committee Disruptions and Workforce Pressures

February saw the cancellation of two pivotal advisory committee meetings: the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC’s Advisory Committee on Immunization Practices (ACIP). These groups, which traditionally review flu vaccine strains and public health recommendations, were sidelined despite a severe 2024–2025 flu season causing up to 92,000 deaths. The administration’s reluctance to convene independent experts marked a departure from decades of transparent vaccine policy development.

Workforce challenges deepened with the February 11 executive order mandating a 4:1 attrition-to-hiring ratio across federal agencies. At the FDA, this exacerbated recruitment struggles in specialized roles, particularly food safety inspectors—25% of whom were retirement-eligible by mid-2024. GAO data revealed the agency had conducted only 917 annual foreign food inspections since 2018, far below its 19,200-target mandate. Domestic inspection backlogs worsened as experienced staff diverted time to train new hires.

March 2025: Policy Shifts and Vaccine Oversight Changes

March brought structural reforms to FDA’s regulatory processes. Secretary Kennedy directed revisions to the Generally Recognized as Safe (GRAS) rule, specifically targeting industry self-affirmed safety determinations for food additives—a move aligned with his criticism of ultra-processed foods. Simultaneously, the FDA revoked authorization for 35 PFAS-containing food contact substances, reflecting heightened chemical safety concerns but straining already limited compliance staff.

Vaccine oversight faced indirect pressure. While no formal guidance withdrawals occurred, Kennedy’s influence raised fears of stricter development criteria for future vaccines. The Office of Vaccines Research and Review (OVRR), depleted by pre-2025 staff departures, risked slowed review timelines amid ongoing attrition. Industry analysts noted that VRBPAC’s cancellation forced manufacturers to align flu vaccine production with non-U.S. markets first, complicating domestic rollout schedules.

Ongoing Impacts: Staffing, Inspections, and Public Health Risks

Workforce and Inspection Capacity

The FDA’s inspectional workforce crisis, highlighted in multiple GAO reports, has reached critical levels. Drug inspections remain 36% below pre-pandemic volumes, with foreign site evaluations particularly lagging. Food safety inspections face similar shortfalls: FDA met only 60% of high-risk domestic facility targets in 2023, contributing to preventable outbreaks like the 2024 E. coli-linked onion crisis. Training new food inspectors requires two years, ensuring gaps will persist and get worse.

Advisory Board Erosion

The administration’s dismissal of advisory committees has introduced unpredictability into vaccine policy. By bypassing VRBPAC for the 2025–2026 flu vaccine strain selection, the FDA abandoned a 50-year precedent of transparent expert review. This politicization risks public trust, particularly as Kennedy’s team weighs revisions to vaccine development guidance without formal stakeholder input.

Regulatory Uncertainty

The regulatory freeze has stalled over 170 planned guidance documents, including updates to AI-enabled medical device oversight and compounding pharmacy rules. Combined with staffing shortages, this has delayed responses to emerging issues like long COVID therapies and drug compounding disputes.

Evaluating the Broader Impact

The Trump administration’s FDA reforms prioritize deregulation and workforce reduction, but collateral damage to public health safeguards is evident:

Food and Drug Safety Risks: Inspection backlogs increase the likelihood of undetected manufacturing violations. GAO warns that inexperienced staff may miss critical compliance issues, elevating risks of adulterated products reaching consumers.
Vaccine Development Challenges: While no direct policy reversals have occurred, the erosion of advisory input and OVRR staffing cuts threaten to delay novel vaccine approvals and strain pandemic preparedness.
Industry Adaptation Costs: Pharmaceutical and food manufacturers face uncertainty as delayed guidance and abrupt policy shifts (e.g., GRAS revisions) disrupt long-term planning.
Global Health Isolation: Withdrawal from WHO collaborations like the Medical Device Single Audit Program (MDSAP) complicates international market access for U.S. device manufacturers.

Conclusion: A Agency at a Crossroads

The FDA’s first quarter under the second Trump administration leadership reveals an agency straining to with foundational public health mandates. Workforce attrition, politicized advisory processes, and stalled rulemaking have collectively undermined the FDA’s capacity to proactively address foodborne illness, drug safety, and vaccine development. With little hope for congressional action to stabilize staffing and safeguard advisory mechanisms, the FDA risks becoming a reactive rather than preventive force in U.S. healthcare—a shift with consequences that could resonate for decades.

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