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.
“It’s our own fault,” said former FDA inspector Peter Baker, who reported a litany of failures during inspections in India and China from 2012 to 2018. “We allowed all these players into the market who never should have been there in the first place. They grew to be monsters and now we can’t go back.”
Four weeks may not seem a lot to outsides (though every day of delay counts when you are talking launch plans) but I am thinking this is not the last, or the greatest, of delays ahead.
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.
I think it is unfortunate that two of the world’s most influential regulatory agencies, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have taken markedly different approaches to transparency in sharing Good Manufacturing Practice (GMP) observations and non-compliance information with the public.
The Foundation of Regulatory Transparency
FDA’s Transparency Initiative
The FDA’s commitment to transparency traces back to the Freedom of Information Act (FOIA) of 1966, which required federal agencies to provide information to the public upon request. However, the agency’s proactive transparency efforts gained significant momentum under President Obama’s Open Government Initiative. In June 2009, FDA Commissioner Dr. Margaret Hamburg launched the FDA’s Transparency Initiative, creating new webpages, establishing FDA-TRACK performance monitoring system, and proposing steps to provide greater public understanding of FDA decision-making.
EMA’s Evolution Toward Transparency
The EMA’s journey toward transparency has been more gradual and complex For many years, EU inspectorates did not publish results of their inspections, unlike the FDA’s long-standing practice of making Form 483s and Warning Letters publicly accessible. This changed significantly in 2014 when the EMA launched a new version of the EudraGMDP database that included, for the first time, the publication of statements of non-compliance with Good Manufacturing Practice.
The EMA’s approach to transparency reflects its commitment to transparency, efficiency, and public health protection through structured partnerships with agencies worldwide 1. However, the agency’s transparency policy has faced criticism for being “marred by too many failings,” particularly regarding pharmaceutical companies’ ability to redact clinical study reports.
FDA’s Comprehensive Data Infrastructure
The FDA operates several interconnected systems for sharing inspection and compliance information:
Form 483 Database and Public Access The FDA maintains extensive databases for Form 483 inspectional observations, which are publicly accessible through multiple channels. The agency’s Office of Inspections and Investigations provides spreadsheets summarizing inspection observations by fiscal year, broken down by product areas including biologics, drugs, devices, and other categories.
FDA Data Dashboard Launched as part of the agency’s transparency initiative, the FDA Data Dashboard presents compliance, inspection, and recall data in an easy-to-read graphical format. The dashboard provides data from FY 2009 onward and allows access to information on inspections, warning letters, seizures, injunctions, and recall statistics. The system is updated semi-annually and allows users to download information, manipulate data views, and export charts for analysis.
Warning Letters and Public Documentation All FDA-issued Warning Letters are posted on FDA.gov in redacted form to permit public access without requiring formal FOIA requests. This practice has been in place for many years, with warning letters being publicly accessible under the Freedom of Information Act.
The EMA’s primary transparency tool is the EudraGMDP database, which serves as the Community database on manufacturing, import, and wholesale-distribution authorizations, along with GMP and GDP certificates. A public version of the database has been available since 2011, providing access to information that is not commercially or personally confidential.
The EudraGMDP database contains several modules including Manufacturing Import Authorisation (MIA), GMP certificates, Wholesale Distribution Authorisation (WDA), and Active Product Ingredient Registration (API REG). The database is publicly accessible without login requirements and is maintained by the EMA with data populated by EEA national competent authorities.
Non-Compliance Reporting and Publication
A significant milestone in EMA transparency occurred in 2014 when the agency began publishing statements of non-compliance with GMP . These documents contain information about the nature of non-compliance and actions taken by issuing authorities to protect public health, aiming to establish coordinated responses by EU medicines regulators.
A major difference here is that the EMA removes non-compliance statements from EudraGMDP following successful compliance restoration. The EMA’s procedures explicitly provide for post-publication modifications of non-compliance information. Following publication, the lead inspectorate authority may modify non-compliance information entered in EudraGMDP, for example, following receipt of new information, with modified statements distributed to the rapid alert distribution list.
This is unfortunate, as it requires going to a 3rd party service to find historical data on a site.
Category
FDA
EMA
Volume of Published Information
Over 25,000 Form 483s in databases
83 non-compliance reports total (2007-2020)
Annual Inspection Volume
Every 483 observation is trackable at a high level
Limited data available
Database Update Frequency
Monthly updates to inspection databases
Updates as available from member states
Dashboard Updates
Semi-annual updates
Not applicable
Historical Data Availability
Form 483s and warning letters accessible for decades under FOIA
Multiple channels: direct database access, FOIA requests
Single portal: EudraGMDP database
Data Manipulation Capabilities
Users can download, manipulate data views, export charts
Basic search and view functionality
Login Requirements
No login required for public databases
No login required for EudraGMDP
Commercial Confidentiality
Redacted information
Commercially confidential information not published
Non-Compliance Statement Removal
Form 483s remain public permanently
Statements can be removed after successful remediation
While both the FDA and EMA have made significant strides in regulatory transparency, the FDA clearly shares more information about GMP observations and non-compliance issues. The FDA’s transparency advantage stems from its longer history of public disclosure under FOIA, more comprehensive database systems, higher volume of published enforcement actions, and more frequent updates to public information.
My next post will be on the recent changes at the FDA and what that means for ongoing transparency.
Investigations of a Dog 