In a time when the FDA needs its best and brightest people onboard, nearly half the senior leadership at the agency will be eligible for retirement by Sept. 30.

The potential loss of institutional memory comes as the FDA is facing increased competition with the private sector and academia for talent with unique and specialized skills due to the rapid pace of medical and scientific advancements.

It also comes as the agency is trying to shift from a lengthy, reactive hiring process that focuses on filling existing vacancies to a more streamlined, proactive system that anticipates and plans for future personnel needs. The agency has made some gains in that shift, but “there’s a lot more to be done,” Melanie Keller, director of the FDA’s Office of Talent Solutions, acknowledged at a meeting Thursday on an interim assessment of the agency’s PDUFA and BsUFA hiring and retention commitments.

On the plus side, turnover at parts of the FDA is relatively low, especially compared with other government agencies that have an average attrition rate of 16%. Except for a few positions and offices, the FDA’s Center for Drug Evaluation and Research (CDER) experiences 5% attrition, while the Center for Biologics Evaluation and Research (CBER) has 6%, said Kristen Stanton, of Booz Allen Hamilton, which conducted the assessment. Stanton attributed the low turnover to staff commitment to the agency.

The downside is that when the FDA loses specialized talent, it lacks a strategic approach to quickly fill the void. Currently, human resources (HR) at the FDA can take more than two years to fill a position under federal Title 5 civil service rules – up to 300 days for the classification request for the position and then another 150 to 550 days for the process of putting together the job description, posting it, selecting a pool of eligible candidates, evaluating candidates, making an offer and bringing a person onboard, Stanton said.

A Scientific Talent Recruiting Staff (STRS) hiring pilot at CDER and CBER reduced the time-to-hire process by more than 60%, but it didn’t address the time it takes to classify a position, which includes setting the civil service and pay grade.

Minimal progress

Given the complexities and challenges of hiring, the FDA has seen small net gains in staffing, even though the 21st Century Cures Act and an expansion of its direct hire authority were intended to help the agency fill new positions needed to meet the demands of its workload and to keep pace with scientific advancements. For instance, the 2016 Cures Act gave the agency additional hiring authority for scientific, technical and professional positions that support the development, review and regulation of medical products.

While the FDA has established foundational planning and governance for use of its Cures hiring authority, it hasn’t used the authority much. As of Sept. 30, 2019, CDER and CBER had made a total of 47 appointments under Cures. And in fiscal 2019, 9% of CDER’s hires were under its Cures authority, whereas 2% of CBER’s hires came under that authority.

Negotiated on the heels of the passage of Cures, PDUFA VI, the FDA’s prescription drug user fee agreement for 2018 through 2022, addressed staffing needs at CDER more so than any other iteration of the agreement. It provided funding to help the center attract scientists with specific expertise in areas such as patient outcome tools, real-world evidence and rare diseases. It also called for the three-phase hiring and retention assessment.

That assessment – which also is part of BsUFA II but not MDUFA IV, the current iteration of the medical device user fee agreement – zeroed in on CDER and CBER. However, the resulting improvements in HR functions will be carried over to the Center for Devices and Radiological Health and other FDA centers. And the best practices learned in the STRS hiring pilot will be applied to the other centers as well.

HR challenges

While Congress has provided the funding and authority for the FDA to hire more specialized scientists and medical experts, the assessment found that the HR resources needed to do that are lagging behind. The interim assessment, which reflects data through fiscal 2019, showed minimal, if any progress, in five key findings from the initial assessment, conducted in 2017, about the FDA’s HR process and data management that impact hiring:

  • Process documentation is incomplete.
  • The process suffers from substantial complexity.
  • Roles and responsibilities are unclear, resulting in confusion and weak accountability.
  • Technology and systems are not user friendly and have low efficiency and transparency.
  • A lack of collaborative dialogue has resulted in poor communication.

Part of the problem is that the agency’s HR offices are persistently understaffed. For instance, the human resources staff in CBER’s Office of Management has a 27% vacancy rate. High vacancies play a large role in increased workload, burnout and attrition among the HR staff, Stanton said.

Another issue the FDA has struggled with is training of its HR staff. According to a survey of HR managers at the FDA, 90% of HR staff were proficient in core competencies, but 42% didn’t meet classification technical competency requirements. The agency is developing ongoing training programs to address those shortcomings.

The HR vacancy rate and lack of training, along with the inability to track many HR functions, all contribute to a general dissatisfaction with HR staff capability at the FDA. Stanton pointed out that only 5% to 8% of hiring managers at the FDA were satisfied or very satisfied with HR staff in the agencywide HR offices and 12% to 19% were satisfied with the HR staff in the CDER and CBER Offices of Management. Satisfaction with the HR staff in center program offices was much better – 39% to 46%.

A big concern for hiring managers at CDER and CBER was that HR staff don’t understand the centers’ technical hiring requirements. They also were dissatisfied with HR customer service and problem-solving skills, staff’s knowledge of HR policies and procedures, and HR’s ability to meet timelines.

The assessment concluded that the FDA hiring process “is overwhelmingly considered to be inefficient and ineffective” and recommended better communication, collaboration, process documentation and guidance to improve the process.

Public comments on the interim assessment may be submitted to Docket No. FDA-2020-N-1500-0001 through Sept. 30. The final assessment is expected to be released in December 2021. In the meantime, Keller said the agency will be completing the third phase of the hiring pilot. In addition, it plans to create an FDA talent strategy to improve hiring and retention, and will deploy its Applicant Tracking Lifecycle and Analysis Solution agency-wide to better manage HR functions and data.

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