FDA Engages in Strategic Workforce Planning, But Lacks Agency-wide Plan to Ensure Effective Management
According to a new report by the Government Accountability Office (GAO), the Food and Drug Administration (FDA) uses the flexibility in hiring and pay requirements afforded by the 21st Century Cures Act (Cures Act) to recruit and retain medical staff. There is, however, no centralized strategic workforce plan or process to measure agency performance currently.
In 2018, FDA launched two new offices within its Office of Human Resources: The Office of Human Capital Management (OHCM) which focused on agency employees, and the Office of Talent Solutions (OTS), which designed a unified recruitment campaign promoting the agency's commitment to public health.
“This approach of forming strategic partnerships and developing a mission-oriented recruitment strategy is consistent with leading practices agencies should use in their recruitment efforts,” the report stated.
In recent years, the FDA has struggled to staff and retain its medical product workforce, as competition from the private sector typically pays higher than the government agency can afford. GAO noted in their report that onboarding is also a challenge because it can take several years for new employees to become trained in their roles, and a high turnover rate further complicates the process.
The Cures Act provided the agency with additional flexibility regarding recruitment and retention of medical product staff. The FDA hires most new employees following the hiring process outlined in the federal government's competitive service. The Cures Act authorizes FDA to facilitate the hiring of scientific, technical, and professional personnel to support the development, review, and regulation of medical products outside the government's General Schedule classification system. According to the GAO’s investigation, FDA officials prefer to employ Cures Act flexibilities over traditional hiring methods because they allow their centers to better target potential candidates and pay higher salaries, both to external candidates FDA seeks to hire and to internal employees it seeks to retain.
The Center for Biologics Evaluation and Research (CBER) is using Cures Act flexibilities for individual cases, such as hiring and retaining oncologists and hematologists, and converting current staff to supervisory roles with Cures Act pay bands. However, as a smaller center within FDA, CBER is concerned about the cost implications of adopting this practice more widely.
GAO noted that the Center for Drug Evaluation and Research (CDER) initially converted certain "mission-critical" positions to Cures Act jobs but has now made the most of it for hiring and retaining staffs at all levels, for instance in rheumatology, anesthesiology, cardiology, neuroimmunology, and rare diseases. According to CDER officials, they prefer to use Cures Act flexibilities as a primary method of hiring and retaining staff going forward, in part so that similarly qualified staff receive comparable pay.
FDA officials expressed a preference for Cures Act flexibilities since, by not requiring jobs to be posted on USAJOBS, it effectively acts as a direct hire authority. Additionally, job postings can be customized by adding specific requirements to avoid referencing potentially out-of-date requirements from the Office of Personnel Management (OPM).
The FDA has taken advantage of Cures Act flexibility to create new critical positions that are able to adapt to changing academic training and technologies, as well as developments in scientific fields that are not reflected in conventional job descriptions. However, recruiting or converting an employee with Cure Act flexibilities requires significant paperwork, and hiring managers need to explain why an individual is exceptional for the work.
CBER and CDER are left to conduct their own workforce planning as there is no centralized workforce plan in place for the FDA. Officials told GAO the agency developed a comprehensive plan in 2017, but it was never adopted. To that effect, GAO recommended FDA develop an agency-wide strategic workforce plan as well as a plan to continually update the strategic workforce plan, which would help keep the agency on course. As the FDA undergoes several transitions, including the human capital office reorganization, Cures Act flexibilities, and the ongoing COVID-19 pandemic, GAO argued creating a workforce strategy is vital.
