FDA Workforce: Agency-wide workforce planning is needed to ensure medical product personnel meet current and future needs

What the GAO found

The United States Food and Drug Administration (FDA), an agency of the Department of Health and Human Services (HHS), is responsible for, among other things, ensuring the safety, efficacy, and security of medical products intended for humans marketed in the United States. The FDA has used a variety of strategies to improve the agency’s ability to recruit and retain scientific, technical, and professional staff for its three centers responsible for oversight of medical products for human use. These centers — the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiation Health — were the subject of GAO’s review.

To improve both recruitment and retention of these centers, the FDA has taken advantage of the hiring and compensation flexibilities provided by the 21st Century Cures Act (Cures Act) to expedite hiring and offer higher salaries than the agency could under traditional federal hiring authorities. The FDA has used these flexibilities to hire and retain staff such as scientists, doctors and regulatory advisers, for whom pay disparities with the private sector are particularly large. The FDA also established a team dedicated to engagement with the scientific community and established a unified brand strategy that emphasizes the agency’s public health mission.

The GAO has found that the FDA follows certain best practices for effective workforce planning for medical product personnel. FDA Medical Product Centers each conduct annual workforce planning in which they determine the skills they need and develop strategies to fill identified gaps. However, the FDA does not have an agency-wide strategic workforce plan to coordinate human capital efforts in medical product centers, nor does it have performance measures. in place to assess the effectiveness of its human capital strategies, as required by leading practices for effectiveness. workforce planning.

FDA Workforce Planning Activities for Medical Products Personnel Against GAO-Identified Best Practices for Effective Workforce Planning

Best practice

Alignment between FDA actions and best practices

Determine the skills needed and develop strategies to fill the gaps

Monitor and evaluate progress towards human capital goals

Develop a strategic workforce plan

Legend: ● = Aligned with best practices; ◒ = Partially aligned with best practices; ○ = Not aligned with best practices

Source: GAO analysis of Food and Drug Administration documents and interviews with officials. | GAO-22-104791

Further, the FDA does not have a process to update such a plan on an ongoing basis should such a plan be developed. FDA’s latest agency-wide strategic workforce plan, covering fiscal years 2010 through 2012, was developed under previous leadership and current agency officials were unaware of it. . Without an agency-wide strategic workforce plan and a process to maintain it, the FDA does not have reasonable assurance that actions taken at its individual centers and offices will help the agency to achieve its overarching goals and mission over time.

Why GAO Did This Study

The FDA relies on a skilled medical product workforce to accomplish its mission of protecting public health. However, the FDA has struggled to meet its medical product workforce needs, in part due to competition with the private sector for applicants.

Enacted in 2016, the 21st Century Cures Act provided additional flexibilities to facilitate the recruitment and retention of medical product personnel by the FDA and included a provision allowing the GAO to review the recruitment and retention of such personnel by the FDA. FDA. This report: (1) describes the strategies FDA uses to recruit, hire, and retain medical product personnel, and (2) assesses the workforce planning processes FDA uses for such personnel. and whether these processes follow leading workforce planning practices.

GAO analyzed FDA policies, guidelines, reports, and data related to recruitment and retention of medical product personnel and workforce planning. The GAO also interviewed FDA officials responsible for hiring such personnel and nonprofit and private sector organizations representing scientific personnel.

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