Two Paths in Our Regulatory World: Leading Through Strategic Engagement

In pharmaceutical quality, we face a fundamental choice that defines our trajectory: we can either help set the direction of our regulatory landscape, or we can struggle to keep up with changes imposed upon us. As quality leaders, this choice isn’t just about compliance—it’s about positioning our organizations to drive meaningful change while delivering better patient outcomes.

The reactive compliance mindset has dominated our industry for too long, where companies view regulators as adversaries and quality as a cost center. This approach treats regulatory guidance as something that happens to us rather than something we actively shape. Companies operating in this mode find themselves perpetually behind the curve, scrambling to interpret new requirements, implement last-minute changes, and justify their approaches to skeptical regulators.

But there’s another way—one where quality professionals actively engage with the regulatory ecosystem to influence the development of standards before they become mandates.

The Strategic Value of Industry Group Engagement

Organizations like BioPhorum, NIIMBL, ISPE, and PDA represent far more than networking opportunities—they are the laboratories where tomorrow’s regulatory expectations are forged today. These groups don’t just discuss new regulations; they actively participate in defining what excellence looks like through standard-setting initiatives, white papers, and direct dialogue with regulatory authorities.

BioPhorum, with its collaborative network of 160+ manufacturers and suppliers deploying over 7,500 subject matter experts, demonstrates the power of collective engagement. Their success stories speak to tangible outcomes: harmonized approaches to routine environmental monitoring that save weeks on setup time, product yield improvements of up to 44%, and flexible manufacturing lines that reduce costs while maintaining regulatory compliance. Most significantly, their quality phorum launched in 2024 provides a dedicated space for quality professionals to collaborate on shared industry challenges.

NIIMBL exemplifies the strategic integration of industry voices with federal priorities, bringing together pharmaceutical manufacturers with academic institutions and government agencies to advance biopharmaceutical manufacturing standards. Their public-private partnership model demonstrates how industry engagement can shape policy while advancing technical capabilities that benefit all stakeholders.

ISPE and PDA provide complementary platforms where technical expertise translates into regulatory influence. Through their guidance documents, technical reports, and direct responses to regulatory initiatives, these organizations ensure that industry perspectives inform regulatory development. Their members don’t just consume regulatory intelligence—they help create it.

The Big Company Advantage—And Why Smaller Companies Must Close This Gap

Large pharmaceutical companies understand this dynamic intuitively. They maintain dedicated teams whose sole purpose is to engage with these industry groups, contribute to standard-setting activities, and maintain ongoing relationships with regulatory authorities. They recognize that regulatory intelligence isn’t just about monitoring changes—it’s about influencing the trajectory of those changes before they become requirements.

The asymmetry is stark: while multinational corporations deploy key leaders to these forums, smaller innovative companies often view such engagement as a luxury they cannot afford. This creates a dangerous gap where the voices shaping regulatory policy come predominantly from established players, potentially disadvantaging the very companies driving the most innovative therapeutic approaches.

But here’s the critical insight from my experience working with quality systems: smaller companies cannot afford NOT to be at these tables. When you’re operating with limited resources, you need every advantage in predicting regulatory direction, understanding emerging expectations, and building the credibility that comes from being recognized as a thoughtful contributor to industry discourse.

Consider the TESTED framework I’ve previously discussed—structured hypothesis formation requires deep understanding of regulatory thinking that only comes from being embedded in these conversations. When BioPhorum members collaborate on cleaning validation approaches or manufacturing flexibility standards, they’re not just sharing best practices—they’re establishing the scientific foundation for future regulatory expectations. When the ISPE comes out with a new good practice guide they are doing the same. The list goes on.

Making the Business Case: Job Descriptions and Performance Evaluation

Good regulatory intelligence practices requires systematically building this engagement into our organizational DNA. This means making industry participation an explicit component of senior quality roles and measuring our leaders’ contributions to the broader regulatory dialogue.

For quality directors and above, job descriptions should explicitly include:

Active participation in relevant industry working groups and technical committees
Contribution to industry white papers, guidance documents, and technical reports
Maintenance of productive relationships with regulatory authorities through formal and informal channels
Intelligence gathering and strategic assessment of emerging regulatory trends
Internal education and capability building based on industry insights

Performance evaluations must reflect these priorities:

Measure contributions to industry publications and standard-setting activities
Assess the quality and strategic value of regulatory intelligence gathered through industry networks
Evaluate success in anticipating and preparing for regulatory changes before they become requirements
Track the organization’s reputation within industry forums as a thoughtful contributor

This isn’t about checking boxes or accumulating conference attendance credits. It’s about recognizing that in our interconnected regulatory environment, isolation equals irrelevance. The companies that will thrive in tomorrow’s regulatory landscape are those whose leaders are actively shaping that landscape today.

Development plans for individuals should have clear milestones based on these requirements, so as individuals work their way up in an organization they are building good behaviors.

The Competitive Advantage of Regulatory Leadership

When we engage strategically with industry groups, we gain access to three critical advantages that reactive companies lack. First, predictive intelligence—understanding not just what regulations say today, but where regulatory thinking is headed. Second, credibility capital—the trust that comes from being recognized as a thoughtful contributor rather than a passive recipient of regulatory requirements. Third, collaborative problem-solving—access to the collective expertise needed to address complex quality challenges that no single organization can solve alone.

The pharmaceutical industry is moving toward more sophisticated quality metrics, risk-based approaches, and integrated lifecycle management. Companies that help develop these approaches will implement them more effectively than those who wait for guidance to arrive as mandates.c

As I’ve explored in previous discussions of hypothesis-driven quality systems, the future belongs to organizations that can move beyond compliance toward genuine quality leadership. This requires not just technical excellence, but strategic engagement with the regulatory ecosystem that shapes our industry’s direction.

The choice is ours: we can continue struggling to keep up with changes imposed upon us, or we can help set the direction through strategic engagement with the organizations and forums that define excellence in our field. For senior quality leaders, this isn’t just a career opportunity—it’s a strategic imperative that directly impacts our organizations’ ability to deliver innovative therapies to patients who need them.

The bandwidth required for this engagement isn’t overhead—it’s investment in the intelligence and relationships that make everything else we do more effective. In a world where regulatory agility determines competitive advantage, being at the table where standards are set isn’t optional—it’s essential.

Threat in Your Medicine Cabinet

True words from Peter Baker:

“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.”

Rose, M., & Cenziper, D. (2024, June 13). Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs. ProPublica. https://www.propublica.org/article/fda-drug-loophole-sun-pharma

Great article, highly recommended.

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

Transparency in GMP Pharmaceutical Oversight

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.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations

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.

https://www.fda.gov/about-fda/performance-data/fda-data-dashboard

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.

https://www.fda.gov/about-fda/office-inspections-and-investigations/oii-foia-electronic-reading-room

EMA’s EudraGMDP Database

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	Non-compliance information public since 2014
Information Scope	Inspections, warning letters, seizures, injunctions, recalls, import alerts	Primarily GMP/GDP certificates and non-compliance statements
Geographic Distribution of Non-Compliance	Global coverage with detailed breakdowns	India: 35 reports, China: 22 reports, US: 4 reports
Real-Time Access	Yes – monthly database updates	Limited – dependent on member state reporting
Public Accessibility	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.

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.

Tag: regulatory state