Preliminary Thoughts on George Tidmarsh

I have a few concerns about George Tidmarsh’s recent appointment as director of the FDA’s Center for Drug Evaluation and Research (CDER) which fits into wider concerns about the current administration. As usual in this adminstration, this boils down to a tendency to fringe medicine and vaccine denial adjacent thinking.

Association with “fringe” medical publishing: Tidmarsh contributed to the Journal of the Academy of Public Health, which Bloomberg and other outlets have described as a “fringe medical journal” connected to a conservative nonprofit.
Criticism of COVID-19 public health policy: Tidmarsh has openly criticized the government’s handling of the COVID-19 pandemic. On the “Derate the Hate” podcast, he lamented what he saw as political polarization and lack of “academic freedom” in pandemic-era policy discussions, and suggested openness to the theory of a lab origin for the coronavirus.

I also find a degree of irony in Tidmarsh’s leadership roles in several biotech and pharmaceutical companies—including as founder and CEO of Horizon Therapeutics and Threshold Pharmaceuticals. RFKJr, and others have spent a lot of time criticizing the revolving door between industry and government regulation. And here we have a great example of that revolving door.

In any other administration, Tidmarsh would be concerning due to his connections to fringe science. In this administration he is another worrisome personnel decision given authority.

Recent Troubles at the FDA and Their Impact on Transparency

The FDA’s long-standing commitment to transparency faces unprecedented challenges in 2025 following a series of organizational disruptions that threaten to undermine the agency’s ability to share critical regulatory information with stakeholders and the public. These developments represent a significant departure from the agency’s historical transparency trajectory and raise serious concerns about the future accessibility of regulatory data and decision-making processes.

Mass Workforce Reductions and Organizational Disruption

The most significant challenge facing FDA transparency stems from the massive reduction in force implemented in April 2025. The Department of Health and Human Services terminated approximately 3,500 FDA employees on April 1, 2025, representing nearly 20% of the agency’s workforce. This dramatic downsizing followed an earlier reduction in February 2025 that eliminated approximately 700 workers, creating a cumulative impact that has fundamentally altered the agency’s operational capacity.

While HHS officials emphasized that the cuts would not directly impact medical product reviewers, food reviewers, or inspectors, the layoffs eliminated critical support staff across multiple areas essential to transparency operations. The reduction in force targeted employees in policy development, communications, information technology, procurement, and project management—all functions that are integral to maintaining the agency’s transparency infrastructure.

Former FDA Commissioner Robert Califf captured the gravity of the situation in a LinkedIn post stating, “The FDA as we’ve known it is finished”. This assessment reflects the widespread concern that the agency’s foundational capabilities for information sharing and public communication have been irreparably damaged.

Communication Infrastructure Breakdown

Press Releases and Public Information Systems

The workforce reductions have created significant gaps in the FDA’s ability to communicate with the public and industry stakeholders. Communications staff responsible for issuing press releases, updating the FDA’s website, and informing consumers about health risks and new product approvals were among those eliminated. This has resulted in delays and inconsistencies in the dissemination of critical safety information and regulatory updates.

The impact on communication capabilities became evident through reports of delayed updates to key databases and reduced responsiveness to routine inquiries from industry participants. Even before the April layoffs, industry observers had noted a decline in FDA’s responsiveness, particularly to non-essential or routine questions, suggesting that the communication infrastructure was already under strain.

Website and Database Management Issues

The FDA’s digital transparency infrastructure has suffered significant disruptions due to the loss of IT support staff. Key databases that physicians and public health experts rely on for drug safety and manufacturing information have been neglected, leaving health professionals without access to basic information about medications they prescribe. An FDA official described the situation as “really a nightmare,” noting that “things that used to function are no longer functioning”.

Specific database problems include missing labeling information in the FDA’s drug database, which provides critical information about drug approvals, labeling changes, and market withdrawals. Most entries since the April 1 job cuts are missing essential labeling information that tells doctors what drugs are approved for, contraindications, dosing instructions, and side effects. Additionally, the National Drug Code Directory, which provides identification codes for pharmaceutical products, has experienced delayed updates due to staff cuts.

Drug Safety Information Delays

One of the most concerning transparency impacts involves delays in drug safety reporting. The FDA’s Drug Safety-Related Labeling Changes (SrLC) database, which typically receives updates every four days, had gone extended periods without updates. This database contains critical information about newly identified risks or side effects of medications already on the market.

Inspection and Compliance Reporting

The FDA’s ability to maintain its extensive inspection and compliance reporting systems faces significant challenges due to support staff reductions. While inspectors themselves were reportedly not affected by the layoffs, inspection support staff responsible for booking travel, securing translators, and managing administrative functions were eliminated.

The impact on inspection transparency is particularly concerning given the FDA’s existing challenges with inspection backlogs. Prior to the workforce reductions, the agency faced criticism for failing to meet pre-pandemic inspection levels, with roughly 2,000 pharmaceutical manufacturers not inspected since before COVID-19. The additional strain from reduced support staff threatens to further compromise the agency’s ability to maintain transparency about facility compliance and inspection outcomes..

Long-term Transparency Implications

Institutional Knowledge Loss

The elimination of thousands of experienced FDA employees represents a significant loss of institutional knowledge that has traditionally supported the agency’s transparency initiatives. Scientists who developed regulatory science standards, policy staff who interpreted regulations, and communications professionals who translated complex regulatory information for public consumption have been removed from the agency.

This knowledge loss threatens the continuity of transparency practices and may result in inconsistent application of disclosure policies as remaining staff struggle to maintain established processes with reduced resources and experience.

Stakeholder Confidence and Trust

The disruption to FDA transparency systems has undermined stakeholder confidence in the agency’s ability to maintain its historical commitment to open government and regulatory clarity. Over 200 biotech leaders signed a letter to the Senate Health, Education, Labor, and Pensions Committee urging the government to “quickly preserve and restore” the FDA’s core functions and avoid delays to promised drug-approval decision dates.

The breakdown of communication systems and delays in critical safety information sharing have created an environment of uncertainty that challenges the trust-based relationship between the FDA and the industries it regulates. This erosion of confidence may have long-term implications for voluntary compliance and cooperative regulatory relationships that have traditionally supported the agency’s transparency objectives.

Conclusion

The recent troubles at the FDA represent the most significant threat to regulatory transparency in decades. The massive workforce reductions, communication infrastructure breakdown, database management failures, and operational disruptions have created a perfect storm that undermines the agency’s ability to maintain its historical commitment to open government and stakeholder engagement.

While the full impact of these changes continues to unfold, early evidence suggests that the FDA’s capacity for transparent regulatory oversight has been fundamentally compromised. The loss of critical support staff, breakdown of communication systems, and delays in safety information sharing represent a dramatic departure from the agency’s transparency trajectory and raise serious questions about the future accessibility of regulatory information.

The implications extend far beyond administrative efficiency, as transparency failures can impact patient safety, undermine industry confidence, and compromise the integrity of the regulatory system. Restoring the FDA’s transparency capabilities will require not only addressing immediate staffing needs but also rebuilding the institutional infrastructure that has traditionally supported the agency’s commitment to open government and regulatory clarity.

Sources

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 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.