How Staffing Changes May Affect FDA Recall Efficiency—and What Healthcare Organizations Can Do Now

Recent reductions in government staffing, particularly within the Department of Health and Human Services (HHS), have raised concerns within healthcare organizations about their potential impact on various functions, including the Food and Drug Administration (FDA) recalls. Here we will explore the potential implications of these staffing cuts and how they may affect the FDA's ability to manage recalls effectively. 

Background on Government Staffing Reductions 

In line with the Department of Government Efficiency Workforce Optimization Initiative, HHS has undergone significant restructuring. The initiative aims to streamline operations and reduce the workforce by approximately 20,000 employees across various divisions, including the FDA. This reduction is part of a broader effort to enhance efficiency and responsiveness while cutting costs. 

The FDA's workforce reduction involves approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. HHS states that "This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors."¹ However, the overall reduction in staffing could still have indirect consequences on the FDA's operations. 

Challenges in Hazard Reporting and Recall Management 

The reduction in staffing could exacerbate existing challenges in hazard reporting and recall management. The FDA relies on timely, accurate reporting from manufacturers and healthcare providers to identify potential hazards. With fewer staff available to review, analyze, and process these reports, the likelihood of delays, data backlogs, and missed safety signals increases—potentially compromising timely recall decisions.  

Potential Consequences for Healthcare Organizations 

• Slower Response Times and Recall Notifications 

Reduced staffing at the FDA may lead to delays in processing and responding to reports of potential hazards. This could lead to slower issuance of recalls, potentially increasing the risk of patient harm. 

• Gaps in Oversight 

Staffing reductions may hinder the FDA's ability to conduct thorough inspections and maintain consistent oversight of medical devices and pharmaceuticals. This could increase the risk of safety issues remaining undetected or unaddressed until they pose a potentially serious threat to patients. 

• Increased Workload 

With fewer staff, remaining employees may be overwhelmed by increased workloads, making it difficult to manage the volume of reports, inspections, and recalls effectively. This strain could lead to delays, missed issues, and potential compromises in patient safety. 

• Impact on Innovation 

The FDA plays a crucial role in ensuring the safety and efficacy of new medical products. Staffing reductions could hinder the agency's ability to review and approve innovative treatments and technologies in a timely manner, potentially delaying access to breakthrough therapies and hindering progress in patient care. 

What Healthcare Organizations Can Do Now 

1. Strengthen Internal Surveillance Systems 
   Enhance monitoring of safety advisories, adverse event reports, and product complaints. Use health IT systems to flag risks associated with devices or pharmaceuticals even before formal FDA recall notices. 
2. Subscribe to Independent Alerting Services 
   Leverage independent organizations, such as ECRI, that issue proactive hazard notifications ahead of, or in the absence of, FDA recalls. These services can serve as early warning systems to help offset delays. 
3. Conduct Regular Recall Readiness Drills 
   Implement and rehearse recall response procedures across clinical, supply chain, and risk management teams to ensure immediate action when alerts are received from any source. 
4. Build Stronger Ties with Suppliers and Manufacturers 
   Establish clear lines of communication with vendors to receive timely updates about voluntary recalls or quality issues—especially in the potential absence of timely FDA confirmation. 
5. Allocate Resources for In-House Risk Assessment 
   With the FDA potentially stretched thin, organizations may need to invest in or examine capacity and capability of internal teams evaluating safety signals and making independent decisions on product use or withdrawal. 
6. Engage in Policy and Advocacy Efforts 
   Partner with professional associations to advocate for transparency and continuity in federal safety oversight and ensure that provider voices are included in ongoing regulatory discussions. 

Looking Ahead 

The situation is still in flux, with ongoing adjustments and updates to the staffing reduction plans. As of now, the FDA has begun notifying employees of the impending layoffs, which are set to take effect by May 27, 2025. 

The exact impact of these changes is yet to be fully realized, and there is considerable uncertainty among FDA staff and industry stakeholders. 

The evolving nature of these cuts means that the FDA's ability to manage recalls effectively could be subject to further changes and challenges in the coming months. 

Conclusion 

The reduction in government staffing within the FDA presents several challenges that could impact the agency's ability to manage recalls effectively. While efforts are being made to streamline operations and enhance efficiency, healthcare organizations must remain vigilant and adopt proactive strategies to address potential gaps. Sustaining the safety of medical devices and pharmaceuticals requires shared responsibility, timely action, and continued investment in risk mitigation measures. 

To learn how ECRI's proactive approach to issuing hazard and recall notifications ahead of the FDA can help bridge any potential gaps due to reduced government oversight, contact us here.

Reference

1. Fact sheet: HHS’ transformation to make America healthy again. U.S. Department of Human Services. April 2, 2025. Accessed April 22, 2025. https://www.hhs.gov/about/news/hhs-restructuring-doge-fact-sheet.html