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Regulatory Focus™ > News Articles > 2022 > 1 > GAO tasks FDA with developing agency-wide workforce plan for medical product staff

GAO tasks FDA with developing agency-wide workforce plan for medical product staff

Posted 17 January 2022 | By Jeff Craven 

GAO tasks FDA with developing agency-wide workforce plan for medical product staff

Centers within the US Food and Drug Administration (FDA) are using the flexibility in hiring and pay requirements afforded by the 21st Century Cures Act (Cures Act) to recruit and retain medical staff, but the agency does not have a workforce plan to track this progress, according to a new report by the Government Accountability Office (GAO).
GAO conducted a study on FDA’s hiring and retention practices for its medical product staff and found the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) have their own workforce plans in place. However, FDA currently does not have a centralized strategic workforce plan or process to measure performance at an agency level, the report stated.
An ongoing challenge for the FDA has been its ability to staff and retain its medical product workforce. One barrier to staffing is competition from the private sector, which typically pays higher than FDA can afford as a government agency. Onboarding is also a challenge, as it can take several years for new hires to get trained in their roles, and a high turnover rate complicates this process, GAO noted in their report.
In 2016, the Cures Act was enacted, which allowed for “additional flexibilities to facilitate FDA’s recruitment and retention of medical product staff.” Whereas most new employees at FDA go through a hiring process as part of the authority granted by the federal government’s civil service system, GAO said the Cures Act grants FDA the ability “to facilitate the hiring of scientific, technical, and professional personnel to support the development, review, and regulation of medical products” with expedited hiring processes and pay outside the government’s General Schedule classification system for federal employees.
“FDA officials said that they favor using the Cures Act flexibilities over traditional hiring because the flexibilities 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,” GAO wrote in their report.
How the Cures Act is being used by FDA centers
The Cures Act is also being used in different ways by CBER, CDER, and CDRH, GAO found. CBER has been successful in using Cures flexibilities for individual cases, such as hiring and retaining oncologists and hematologists. The center has also used Cures Act flexibilities to hire for senior leadership roles and to convert existing staff to supervisory roles with Cures Act pay bands, but CBER has expressed budgetary concerns about broadly adopting this practice as a smaller center within FDA.
At first, CDER hired and converted “mission-critical” positions at the center to Cures Act positions but has recently expanded its use to “greatest extent possible for hiring and retention at all levels,” GAO noted, with areas of focus for hiring under the Cures Act including rheumatology, anesthesiology, cardiology, neuroimmunology, and rare diseases. “CDER officials told us they would prefer to use Cures Act flexibilities as the primary way to hire and retain staff going forward, in part to create more consistency across the center—so that similarly qualified staff receive comparable pay,” GAO wrote.
While conversion of management supervisory positions has mainly been the focus at CDRH, the center has also used Cures Act flexibilities to hire for regulatory policy analysts and counsel, physicians, data scientists, and radiologist positions, according to the report.
Overall, officials at FDA noted they prefer the Cures Act flexibilities because, by not requiring jobs be posted on the federal government’s employment site USAJOBS, “it effectively acts as a direct hire authority.” Other benefits include the ability to add specific requirements to a job listing without the need to reference potentially out-of-date requirements from the United States Office of Personnel Management. “FDA has used Cures Act flexibilities to create new critical positions that adapt to changing academic training, technology, and developments in scientific fields that are not adequately captured under the traditional job descriptions,” GAO wrote.
All three centers cited challenges in using Cure Act flexibilities to hire and retain medical product staff. There is a large amount of paperwork needed to recruit or convert an employee using Cure Act flexibilities, and the hiring manager needs to take time to justify why a person being considered is outstanding for the role, according to the report.
Recruitment and retention strategies
In 2018, FDA created two new offices borne out of its Office of Human Resources: the Office of Human Capital Management (OHCM) focused on current agency employees, and the Office of Talent Solutions (OTS) and the Scientific Staffing Outreach Branch.
At the Outreach Branch, GAO found the office had developed a unified advertising campaign focusing on a prospective hire’s desire to make a difference in public health. Through the Outreach Branch, FDA is also expanding its social media profile, posting jobs in a centralized job board, and building relationships with organizations representing medical product staff.
“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,” GAO wrote.
GAO recommends areas for improvement
One big finding of the GAO report is that while CBER, CDER, and CDRH all conduct yearly workforce planning within their own centers, there is no centralized FDA plan. Officials told GAO that a plan was developed for 2017 through 2020 but 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 during transition of leadership.
“Our prior work has found that strategic workforce planning is particularly important for agencies with science and technology missions such as FDA, which must compete for talent with the private sector, universities, and non-profit research centers, and keep up with scientific advancements,” they wrote.
“Given FDA’s recent period of transitions, including the human capital office reorganization, implementation of Cures Act flexibilities, and the challenges facing the agency as it responds to the COVID-19 pandemic, a strategic workforce plan and a process in place to keep that plan up to date would provide a coordinated direction to guide the agency and its workforce through these changes.”
GAO: Agency-Wide Workforce Planning Needed to Ensure Medical Product Staff Meet Current and Future Needs


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