US FDA Staff Slams Agency Hiring Policies In Report Ahead Of Public Meeting

Agency to discuss results of report, as well as pending 2018 pilot project designed to modernize its hiring practices.

The level of frustration that mangers at the US FDA have with the agency’s hiring practices probably can’t be overstated. One individual in the agency’s executive leadership has "no idea" how to evaluate a center's hiring performance, while a hiring manager noted that there is "a profound disconnect of mission" in recruiting and retaining talented staff.

These were just a few of the rather scathing assessments of FDA's hiring process in a Nov. 15 report released by the agency on an initial assessment of its hiring and retention.

FDA commissioned the report to diagnose the root causes of challenges in the hiring process, and to outline a path forward to meet its staffing commitments in the user fee reauthorizations. (Also see "FDA's Breakthrough Workload Will Be Eased By Hiring Reviewers With PDUFA VI Funds" - Pink Sheet, 20 Jul, 2016.) The report primarily focuses on staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

CDER and CBER both have vacancy rates of 14%, which is higher than the benchmark numbers of other government agencies, which have vacancy rates between 5% to 7%, according to the report.

The report was released ahead of a Nov. 30 public meeting, where FDA will discuss its results, as well as an upcoming pilot project slated to begin in 2018.

Widespread Dissatisfaction

FDA's report found many at the agency found both the means and the ends of FDA's hiring process dissatisfying:

• 34% of survey respondents were satisfied with the overall hiring process
• 11% of CDER and 6% of CBER hiring managers felt that recruiting and hiring processes are standardized and consistent
• 31% of CDER and CBER hiring managers were “very satisfied” with the quality of their hires

Unclear Policies

The qualitative commentary from FDAers was among the several sources that helped the report identify a series of root causes of challenges in the agency's hiring process.

One of the most significant root causes identified was the lack of fully defined and consistent hiring processes that are transparent to stakeholders. According to the report, six of the eight major process steps lack documentation or are documented "in an unclear or inaccessible fashion." Roughly one in four of CDER administrative officials said where were no documented standard operating procedures related to hiring procedures or that they were unsure of their existence.

"I have no idea what the performance of my center is from a hiring perspective," the aforementioned individual from FDA's executive leadership says in the report. "There is no simple dashboard that circulates on an ongoing basis. Every time I want to dig into the data, it is a time intensive process that takes people away from their day to day.”

Three in four of the CBER and CDER hiring managers surveyed said they would use a web page or centralized area with information on hiring processes, documented process guidance and/or checklists and cheat sheets for hiring if given the option.

The unclear policies have contributed to the 152-day average time to hire in CDER and CBER.

Unaligned Culture And Mindset

The report also identifies another root cause of hiring challenges as being a mindset and behavior that do not support "effective and collaborative execution of the hiring process."

On the disconnect of mission, the above hiring manager added that, "The timely recruitment and retention of talent to do high-quality work do not seem to be a purpose or goals."

"The purpose seems to be prevention of extra-process practice," the hiring manager said. "I had someone in [human resources] tell me the purpose of her job was to prevent inappropriate hires and make sure all procedures were followed. She succeeded in her goals, but we remain under ceiling.”

Other individuals surveyed also took aim at the Office of Human Resources (OHR) and the Office of Management (OM).

“The administrative staff in the programs, OM, and OHR do not do their job properly," one individual is quoted as saying. "They lose documents, do not keep track of applicants.”

According to the report, there is also a broad consensus that HR staff often fail to proactively find solutions to hiring-related challenges. More than half – 55% – of CDER hiring managers are not satisfied with the extent to which the OHR servicing team takes “initiative to solve problems that arise.”

But HR staffers reported problems with culture stemming from their superiors. Motivation is weak in OHR, the report states, because of a lack of personal ownership, rewards and recognition. According to the report, HR specialists are frustrated with poor support from senior leadership, and only 51% of HR specialists report being satisfied with their current level of recognition and rewards they receive for quality work. (See chart at end of article for all root causes discussed.)

Upcoming Pilot Project

FDA will also discuss its upcoming pilot program on the agency's hiring process, which is slated to launch in 2018.

The report provides several recommendations for elements the pilot should test, including:

• A process design focused on minimizing handoffs, eliminating unnecessary process steps and reducing total time to hire;
• Re-evaluation and use of flexibilities embedded in current hiring authorities, including those related to employee performance, appraisal, training and development, attendance;
• Identification of new talent sources; and
• Targeted investments to enhance HR capabilities in communication, timeliness, and personal initiative;

FDA Commissioner Scott Gottlieb said in a Nov. 15 blog post that the pilot "will leverage the key findings from the initial assessment and that will modernize and streamline hiring practices by using new IT tools and eliminating unnecessary processes."

"The pilot will focus on the end to end hiring process beginning with the day the need for new staff is identified to the day a candidate is hired," Gottlieb says. "It will directly align our administrative hiring procedures with the scientific objectives of our programs."

A Public Comment Period?

According to the meeting's final agenda, the three-hour session will close out with a 65-minute public comment period.

The arrangement appears a bit unusual on its face, as most FDA public meetings usually involve public comments on issues that directly impact stakeholders. In this case, the agency's hiring process has more of an indirect impact on stakeholders. It is therefore unclear what the public discussion might look like.

Root Causes of Hiring Challenges
Dimension	Root Cause		Severity Of Gap		Criticality In Hiring Process
Processes and Policies	Process is not fully defined or documented in a way that is transparent to all stakeholders		Major		Major
	Existing set of policies, legal requirements, and/or FDA interpretation of requirements constrain ability to implement process effectively and consistently		Moderate		Moderate
	Process itself is not well designed		Major		Major
Organization and People	Organizational structure limits ability to execute an efficient process		Major		Major
	Inadequate resources exist to executive process efficiently and effectively		Minor		Moderate
	Unclear and variable positions and responsibilities among stakeholders create process confusion and executional redundancy		Moderate		Major
	Skill gaps and inadequate training of HR staff inhibit successful hiring process		Major		Major
Data and Systems	Current data tracking metrics are insufficient to enable effective accountability and end-to-end management of the process		Major		Major
	IT systems are not consistently integrated, user friendly, or supportive of an efficient, effective hiring process		Major		Moderate
Culture and Mindset	Inconsistent performance goals, SLAs, or enforcement of expectations undermines accountability throughout process		Major		Moderate
	Mindset and behavior do not support effective and collaborative execution of process		Major		Major