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

Understanding Policies

The article “Research: Do New Hires Really Understand Your Policies?” by Rachel Schlund and Vanessa Bohns in HBR does a great job discussing consent that I think have real ramifications on GMP training, especially of the read-and-understood variety. Really gets me thinking on GxP orientation and the building of informed consent.

GxP New Hire Orientation

Building Effective Consent

1. Transparent Communication

Provide clear, detailed information about the why’s.

2. Staged Introduction

Instead of overwhelming new hires with all that GxP training at once, introduce them gradually over time. This approach gives employees the opportunity to digest and comprehend each requirement individually.

3. Interactive Training Sessions

Conduct engaging training sessions that explain the rationale behind each major requirement set and allow employees to ask questions and voice concerns.

4. Regular Policy Reviews

Implement periodic reviews with employees to ensure ongoing understanding and address any evolving concerns or questions.

5. Clear Benefits Communication

Explain the benefits of each requirement to the employee and the organization, helping new hires understand the value and purpose behind the requirements.

Measuring the Effectiveness of Risk Analysis in Engaging the Risk Management Decision-Making Process

Effective risk analysis is crucial for informed decision-making and robust risk management. Simply conducting a risk analysis is not enough; its effectiveness in engaging the risk management decision-making process is paramount. This effectiveness is largely driven by the transparency and documentation of the analysis, which supports both stakeholder and third-party reviews. Let’s explore how we can measure this effectiveness and why it matters.

The Importance of Transparency and Documentation

Transparency and documentation form the backbone of an effective risk analysis process. They ensure that the methodology, assumptions, and results of the analysis are clear and accessible to all relevant parties. This clarity is essential for:

Building trust among stakeholders
Facilitating informed decision-making
Enabling thorough reviews by internal and external parties
Ensuring compliance with regulatory requirements

Key Metrics for Measuring Effectiveness

To gauge the effectiveness of risk analysis in engaging the decision-making process, consider the following metrics:

1. Stakeholder Engagement Level

Measure the degree to which stakeholders actively participate in the risk analysis process and utilize its outputs. This can be quantified by:

Number of stakeholder meetings or consultations
Frequency of stakeholder feedback on risk reports
Percentage of stakeholders actively involved in risk discussions

2. Decision Influence Rate

Assess how often risk analysis findings directly influence management decisions. Track:

Percentage of decisions that reference risk analysis outputs
Number of risk mitigation actions implemented based on analysis recommendations

3. Risk Reporting Quality

Evaluate the clarity and comprehensiveness of risk reports. Consider:

Readability scores of risk documentation
Completeness of risk data presented
Timeliness of risk reporting

This is a great place to leverage a rubric.

4. Third-Party Review Outcomes

Analyze the results of internal and external audits or reviews:

Number of findings or recommendations from reviews
Time taken to address review findings
Improvement in review scores over time

5. Risk Analysis Utilization

Measure how frequently risk analysis tools and outputs are accessed and used:

Frequency of access to risk dashboards or reports
Number of departments utilizing risk analysis outputs
Time spent by decision-makers reviewing risk information

Implementing Effective Measurement

To implement these metrics effectively:

Establish Baselines: Determine current performance levels for each metric to track improvements over time.
Set Clear Targets: Define specific, measurable goals for each metric aligned with organizational objectives.
Utilize Technology: Implement risk management software to automate data collection and analysis, improving accuracy and timeliness.
Regular Reporting: Create a schedule for regular reporting of these metrics to relevant stakeholders.
Continuous Improvement: Use the insights gained from these measurements to refine the risk analysis process continually.

Assessing the Quality of Our Risk Management Activities

Enhancing Transparency and Documentation

To improve the effectiveness of risk analysis through better transparency and documentation:

Standardize Risk Reporting

Develop standardized templates and formats for risk reports to ensure consistency and completeness. This standardization facilitates easier comparison and analysis across different time periods or business units.

Implement a Risk Taxonomy

Create a common language for risk across the organization. A well-defined risk taxonomy ensures that all stakeholders understand and interpret risk information consistently.

Leverage Visualization Tools

Utilize data visualization techniques to present risk information in an easily digestible format. Visual representations can make complex risk data more accessible to a broader audience, enhancing engagement in the decision-making process.

Maintain a Comprehensive Audit Trail

Document all steps of the risk analysis process, including data sources, methodologies, assumptions, and decision rationales. This audit trail is crucial for both internal reviews and external audits.

Foster a Culture of Transparency

Encourage open communication about risks throughout the organization. This cultural shift can lead to more honest and accurate risk reporting, ultimately improving the quality of risk analysis.

Conclusion

Measuring the effectiveness of risk analysis in engaging the risk management decision-making process is crucial for organizations seeking to optimize their risk management strategies. By focusing on transparency and documentation, and implementing key metrics to track performance, organizations can ensure that their risk analysis efforts truly drive informed decision-making and robust risk management.

Remember, the goal is not just to conduct risk analysis, but to make it an integral part of the organization’s decision-making fabric. By continuously measuring and improving the effectiveness of risk analysis, organizations can build resilience, enhance stakeholder trust, and navigate uncertainties with greater confidence.

Transparency at the FDA

Leveling Up Agency Disclosures

I fully agree with this excellent post and its closing line “The public should therefore not need to request such materials from the agency, but should have easy, online access to them at any time.”

All 483s, complete response letters (CRL), and other FDA decisions should be easily accessible. This would be a net positive gain for our profession. I know I’ve reached out to my congress critters about this as the FDA is going through budgeting (and Congress continues to not fund the agency enough).

Accountability does not go away to be Psychologically Safe

A common and distorted application of psychological safety is that it is somehow a shield from accountability. Non-performing employees tend to invoke it as an excuse for poor performance, insisting that a focus on psychological safety means valuing people and building relationships. That’s true, but stretching the premise, they claim that we should give them a pass when they don’t perform.

The flawed logic seems to be along the lines of because we may have used fear and intimidation, command and control, and manipulative and coercive tactics with people in the past, in an attempt to hold folks accountable, we must shed the artifacts that drive accountability in order to have an environment of psychological safety.

In my experience, this is especially prevalent when discussing metrics around overdue quality systems records and training. How to discuss what is late, can you even publish a list of folks with overdue training?

I want to be very clear, psychological safety is not a kind of diplomatic immunity from having to deliver results. It is not a shield from accountability.

Being held accountable can be looked at as transparency in progress. Psychological safety allows us to be vulnerable and to trust that the organization will take the problems seriously and address them.