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.
People who have gone through consent decrees and other regulatory challenges (and I know several individuals who have done so more than once) tend to joke that every year under a consent decree is equivalent to 10 years of experience anywhere else. There is something to this joke, as consent decrees represent unique opportunities for accelerated learning and expertise development that can fundamentally transform organizational capabilities. This phenomenon aligns with established scientific principles of learning under pressure and deliberate practice that your organization can harness to create sustainable, healthy development programs.
Understanding Consent Decrees and PAI/PLI as Learning Accelerators
A consent decree is a legal agreement between the FDA and a pharmaceutical company that typically emerges after serious violations of Good Manufacturing Practice (GMP) requirements. Similarly, Post-Approval Inspections (PAI) and Pre-License Inspections (PLI) create intense regulatory scrutiny that demands rapid organizational adaptation. These experiences share common characteristics that create powerful learning environments:
High-Stakes Context: Organizations face potential manufacturing shutdowns, product holds, and significant financial penalties, creating the psychological pressure that research shows can accelerate skill acquisition. Studies demonstrate that under high-pressure conditions, individuals with strong psychological resources—including self-efficacy and resilience—demonstrate faster initial skill acquisition compared to low-pressure scenarios.
Forced Focus on Systems Thinking: As outlined in the Excellence Triad framework, regulatory challenges force organizations to simultaneously pursue efficiency, effectiveness, and elegance in their quality systems. This integrated approach accelerates learning by requiring teams to think holistically about process interconnections rather than isolated procedures.
Third-Party Expert Integration: Consent decrees typically require independent oversight and expert guidance, creating what educational research identifies as optimal learning conditions with immediate feedback and mentorship. This aligns with deliberate practice principles that emphasize feedback, repetition, and progressive skill development.
The Science Behind Accelerated Learning Under Pressure
Recent neuroscience research reveals that fast learners demonstrate distinct brain activity patterns, particularly in visual processing regions and areas responsible for muscle movement planning and error correction. These findings suggest that high-pressure learning environments, when properly structured, can enhance neural plasticity and accelerate skill development.
The psychological mechanisms underlying accelerated learning under pressure operate through several pathways:
Stress Buffering: Individuals with high psychological resources can reframe stressful situations as challenges rather than threats, leading to improved performance outcomes. This aligns with the transactional model of stress and coping, where resource availability determines emotional responses to demanding situations.
Enhanced Attention and Focus: Pressure situations naturally eliminate distractions and force concentration on critical elements, creating conditions similar to what cognitive scientists call “desirable difficulties”. These challenging learning conditions promote deeper processing and better retention.
Evidence-Based Learning Strategies
Scientific research validates several strategies that can be leveraged during consent decree or PAI/PLI situations:
Retrieval Practice: Actively recalling information from memory strengthens neural pathways and improves long-term retention. This translates to regular assessment of procedure knowledge and systematic review of quality standards.
Spaced Practice: Distributing learning sessions over time rather than massing them together significantly improves retention. This principle supports the extended timelines typical of consent decree remediation efforts.
Interleaved Practice: Mixing different types of problems or skills during practice sessions enhances learning transfer and adaptability. This approach mirrors the multifaceted nature of regulatory compliance challenges.
Elaboration and Dual Coding: Connecting new information to existing knowledge and using both verbal and visual learning modes enhances comprehension and retention.
Creating Sustainable and Healthy Learning Programs
The Sustainability Imperative
Organizations must evolve beyond treating compliance as a checkbox exercise to embedding continuous readiness into their operational DNA. This transition requires sustainable learning practices that can be maintained long after regulatory pressure subsides.
Cultural Integration: Sustainable learning requires embedding development activities into daily work rather than treating them as separate initiatives.
Knowledge Transfer Systems: Sustainable programs must include systematic knowledge transfer mechanisms.
Healthy Learning Practices
Research emphasizes that accelerated learning must be balanced with psychological well-being to prevent burnout and ensure long-term effectiveness:
Psychological Safety: Creating environments where team members can report near-misses and ask questions without fear promotes both learning and quality culture.
Manageable Challenge Levels: Effective learning requires tasks that are challenging but not overwhelming. The deliberate practice framework emphasizes that practice must be designed for current skill levels while progressively increasing difficulty.
Recovery and Reflection: Sustainable learning includes periods for consolidation and reflection. This prevents cognitive overload and allows for deeper processing of new information.
Program Management Framework
Successful management of regulatory learning initiatives requires dedicated program management infrastructure. Key components include:
Governance Structure: Clear accountability lines with executive sponsorship and cross-functional representation ensure sustained commitment and resource allocation.
Milestone Management: Breaking complex remediation into manageable phases with clear deliverables enables progress tracking and early success recognition. This approach aligns with research showing that perceived progress enhances motivation and engagement.
Resource Allocation: Strategic management of resources tied to specific deliverables and outcomes optimizes learning transfer and cost-effectiveness.
Implementation Strategy
Phase 1: Foundation Building
Conduct comprehensive competency assessments
Establish baseline knowledge levels and identify critical skill gaps
Design learning pathways that integrate regulatory requirements with operational excellence
Phase 2: Accelerated Development
Implement deliberate practice protocols with immediate feedback mechanisms
Measures engagement and perceived relevance of GMP training
LMS (Learning Management System)
Level 1: Reaction
KRI
Leading
% Surveys with Negative Feedback (<70%)
Identifies risk of disengagement or poor training design
Survey Tools
Level 1: Reaction
KBI
Leading
Participation in Post-Training Feedback
Encourages proactive communication about training gaps
Attendance Logs
Level 2: Learning
KPI
Leading
Pre/Post-Training Quiz Pass Rate (≥90%)
Validates knowledge retention of GMP principles
Assessment Software
Level 2: Learning
KRI
Leading
% Trainees Requiring Remediation (>15%)
Predicts future compliance risks due to knowledge gaps
LMS Remediation Reports
Level 2: Learning
KBI
Lagging
Reduction in Knowledge Assessment Retakes
Validates long-term retention of GMP concepts
Training Records
Level 3: Behavior
KPI
Leading
Observed GMP Compliance Rate During Audits
Measures real-time application of training in daily workflows
Audit Checklists
Level 3: Behavior
KRI
Leading
Near-Miss Reports Linked to Training Gaps
Identifies emerging behavioral risks before incidents occur
QMS (Quality Management System)
Level 3: Behavior
KBI
Leading
Frequency of Peer-to-Peer Knowledge Sharing
Encourages a culture of continuous learning and collaboration
Meeting Logs
Level 4: Results
KPI
Lagging
% Reduction in Repeat Deviations Post-Training
Quantifies training’s impact on operational quality
Deviation Management Systems
Level 4: Results
KRI
Lagging
Audit Findings Related to Training Effectiveness
Reflects systemic training failures impacting compliance
Regulatory Audit Reports
Level 4: Results
KBI
Lagging
Employee Turnover
Assesses cultural impact of training on staff retention
HR Records
Level 2: Learning
KPI
Leading
Knowledge Retention Rate
% of critical knowledge retained after training or turnover
Post-training assessments, knowledge tests
Level 3: Behavior
KPI
Leading
Employee Participation Rate
% of staff engaging in knowledge-sharing activities
Participation logs, attendance records
Level 3: Behavior
KPI
Leading
Frequency of Knowledge Sharing Events
Number of formal/informal knowledge-sharing sessions in a period
Event calendars, meeting logs
Level 3: Behavior
KPI
Leading
Adoption Rate of Knowledge Tools
% of employees actively using knowledge systems
System usage analytics
Level 2: Learning
KPI
Leading
Search Effectiveness
Average time to retrieve information from knowledge systems
System logs, user surveys
Level 2: Learning
KPI
Lagging
Time to Proficiency
Average days for employees to reach full productivity
Onboarding records, manager assessments
Level 4: Results
KPI
Lagging
Reduction in Rework/Errors
% decrease in errors attributed to knowledge gaps
Deviation/error logs
Level 2: Learning
KPI
Lagging
Quality of Transferred Knowledge
Average rating of knowledge accuracy/usefulness
Peer reviews, user ratings
Level 3: Behavior
KPI
Lagging
Planned Activities Completed
% of scheduled knowledge transfer activities executed
Project management records
Level 4: Results
KPI
Lagging
Incidents from Knowledge Gaps
Number of operational errors/delays linked to insufficient knowledge
Incident reports, root cause analyses
The Transformation Opportunity
Organizations that successfully leverage consent decrees and regulatory challenges as learning accelerators emerge with several competitive advantages:
Enhanced Organizational Resilience: Teams develop adaptive capacity that serves them well beyond the initial regulatory challenge. This creates “always-ready” systems, where quality becomes a strategic asset rather than a cost center.
Accelerated Digital Maturation: Regulatory pressure often catalyzes adoption of data-centric approaches that improve efficiency and effectiveness.
Cultural Evolution: The shared experience of overcoming regulatory challenges can strengthen team cohesion and commitment to quality excellence. This cultural transformation often outlasts the specific regulatory requirements that initiated it.
Conclusion
Consent decrees, PAI, and PLI experiences, while challenging, represent unique opportunities for accelerated organizational learning and expertise development. By applying evidence-based learning strategies within a structured program management framework, organizations can transform regulatory pressure into sustainable competitive advantage.
The key lies in recognizing these experiences not as temporary compliance exercises but as catalysts for fundamental capability building. Organizations that embrace this perspective, supported by scientific principles of accelerated learning and sustainable development practices, emerge stronger, more capable, and better positioned for long-term success in increasingly complex regulatory environments.
Success requires balancing the urgency of regulatory compliance with the patience needed for deep, sustainable learning. When properly managed, these experiences create organizational transformation that extends far beyond the immediate regulatory requirements, establishing foundations for continuous excellence and innovation. Smart organizations can utilzie the same principles to drive improvement.
I’m greatly saddened to hear about the six sites Resilience is shutting down. This impacts a lot of good people, at a time when our industry has had a lot of announced layoffs. My heart goes out to everyone impacted. And please know whatever little help I can do, I will.
For me, there is also a lot of sadness for the site, which was a very definitive part of my career. It truly feels like the end of an era.
Current Status of the Allston Site
National Resilience’s Allston facility at 500 Soldiers Field Road is among the six manufacturing sites being closed as part of the company’s restructuring efforts. The site, which operates in a former Genzyme manufacturing plant built in 1991, is being wound down through legal proceedings initiated by a leaseholder affiliate.
The closure is part of National Resilience’s broader strategy to address overcapacity issues, as CEO William Marth acknowledged that “our capacity expansion has outpaced industry demand”. The company secured $250 million in bridge financing to support this consolidation and is pursuing additional debt financing for future operations. To be frank, some folks bet very poorly.
Harvard’s Property Ownership and Lease Arrangements
The Allston site sits on Harvard-owned land, and the property arrangement involves a complex ownership structure:
Land Ownership: Harvard University owns the underlying land at 500 Soldiers Field Road
Facility Operations: National Resilience took over the lease for the building from Sanofi in 2021, inheriting operations of the former Genzyme plant
Historical Context: Genzyme originally built the facility in 1991 on Harvard land through a long-term lease arrangement
When Sanofi (which had acquired Genzyme) decided to consolidate operations at its Framingham campus, it transferred the lease to National Resilience rather than selling the property outright. This transfer required termination of the site’s special tax-break status through the Boston Planning & Development Agency.
What Happens After National Resilience’s Departure
While I have no definitive answer, I’m fearing the following will drive the site closure and ceasing to be a manufacturing site:
Lease Structure: Since Harvard owns the land and National Resilience operates under a lease arrangement, the property would typically revert to Harvard’s direct control once the lease is terminated or expires.
Strategic Location: The site is strategically positioned within Harvard’s broader Allston development plans, sitting adjacent to the university’s Enterprise Research Campus project. Harvard’s construction updates consistently reference the facility as a landmark bordering their major mixed-use development.
Harvard’s Allston Holdings: The university owns approximately 360 acres in Allston and has been actively developing the area as part of its long-term expansion strategy. The 500 Soldiers Field Road site represents a significant piece of this puzzle.
Integration with Harvard’s Development Plans
Harvard’s ongoing Enterprise Research Campus development directly borders the National Resilience facility, with construction updates regularly using it as a reference point for the project boundaries. The campus will include:
Two laboratory buildings for research and development
A 343-unit residential building with affordable housing components
A hotel and conference center
Public green space and programming areas
The proximity and Harvard’s ownership structure suggest the Allston site could potentially be integrated into future phases of the university’s development plans, though no specific announcements have been made regarding immediate reuse plans.
I don’t think it will surprise anyone that Harvard had reached out to Sanofi many times to discuss taking back the site over the years.
It is odd enough now to drive by and know the site is a shadow of its former self. Knowing that later this year it will be fully closed down is heart breaking.
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 