Executive Summary

US FDA’s drug center has been hiring more employees than it has lost over the last few months and hopes the Office of New Drugs reorganization will help retention.

The US FDA’s new hiring programs are beginning to pay dividends, as incoming employees are outnumbering departures within the Center for Drug Evaluation and Research.

The center has gained about 20 additional employees per month than it has lost over the last couple months, thanks to a pilot program established as part of implementation of the 2016 21st Century Cures Act, Director Janet Woodcock said.

“We’re seeing some gains rather than actual net losses to our staff,” Woodcock said Nov. 14 during Biopharma Congress IV, sponsored by Prevision Policy and the Friends of Cancer Research. “We’re very hopeful that trend will continue.”

While the gain is modest compared to the vacancies that need to be filled within the center, increasing the employee count month to month certainly is a step in the right direction.

CDER’s problems bringing in new staff are well-known. There are about 1,000 vacancies among rank-and-file and senior leadership positions the center is authorized to fill. The federal salary schedule and conflict of interest rules make finding candidates difficult and the lengthy hiring process often means some are lost to other opportunities.

The Cures-related pilot program is aimed at streamlining recruiting and onboarding. (Also see “US FDA’s Streamlined Hiring Pilot Restarts After Delay ” – Pink Sheet, 15 Aug, 2018.)

Other enhancements aimed at making some FDA jobs more attractive have not materialized yet. A Cures-mandated expansion of the Senior Biomedical Research Service, intended to help FDA attract top scientific research talent, is not expected to be in place until late 2019.

At the same time, CDER likely does not want to fill all its openings right away because it would not have enough space for them on the White Oak campus. FDA’s headquarters can accommodate about 5,500 of CDER’s 6,000 authorized positions. (Also see “US FDA May Wait Until Late 2019 Before A Cures Hiring Enhancement Is Available” – Pink Sheet, 27 Sep, 2018.)

The General Services Administration said in a Federal Register notice expected to be published Nov. 27 that it had finalized a master plan for White Oak expansion that includes building two new office towers to create more space, although it is unclear when or if the project will be completed. (Also see “The Two Towers: US FDA’s HQ Expansion Plans Include Office High-Rises, New Conference Center” – Pink Sheet, 17 Sep, 2018.)

OND Reorg Creating Opportunities

CDER is hoping the Office of New Drugs reorganization also will help with employee recruitment and retention.

The proposed new OND structure will create many new divisions and offices as part of a shift to better balance the workload and increase its focus on therapeutic areas. (Also see “Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions ” – Pink Sheet, 4 Jun, 2018.)

Along with a new structure will be several new leadership positions that veteran reviewers and team leaders can step into or the agency could fill with outside talent.

Deputy OND Director Peter Stein said during the conference that division directors already have indicated they have ambitious staffers willing to move into new leadership roles.

“One of the downsides of reorganization in the government is it takes a long time and one of the upsides is it takes a long time,” Stein said. “It gives us a chance to think about this, work on it, develop a staffing plan and we’re actively doing that.”

Amy McKee, Oncology Center of Excellence deputy director, fully expected staff within oncology especially to be looking for new leadership opportunities. She said there are a mix of people interested in moving up, as well as content with their current position.

“I think there are clearly reviewers who love the primary review work and they’re never going to want to leave primary work,” McKee said during the conference. “There are people who like me think ‘You know I’d like to see maybe a broader view of what we do in oncology or a broader view of what we do in CDER or a broader view of what we do in the agency.’ So I think within each disease area you’re going to have both kinds of people.”

“I know in oncology we have some people who are definitely chomping at the bit to get more opportunities and see more and do more from a different perspective,” she added.

New division and office directors and deputy directors cannot be appointed until the reorganization is approved, which is not expected until late 2019. In the meantime, some may be appointed as acting or transition leads or detailed to the positions. Stein told the Pink Sheet after the session that existing office and division directors are beginning to think about whom could fill the new positions.

In addition, Stein is expected to soon step into a new leadership role as OND Director. (See sidebar above.)

Developing Careers Even Though ‘Everyone Can’t Be A Director’

OCE also continues to nurture the academic setting that it hopes will encourage employees to stay with the agency. Director Richard Pazdur said the goal is to ensure his employees feel they are growing in their careers.

“No one of quality will stay at the agency if they don’t feel that they are growing in their careers and I don’t mean simply growing along the administrative hierarchy here, but also scientifically and developing a career that is recognized by people,” he said. “Part of the OCE was a realization everyone can’t be a director, everybody can’t be a deputy director, but there are positions such as these associate directors that we have that are in charge of scientific programs of really developing the science with our external stakeholders.”

Pazdur also said OCE “is trying to integrate the staff with the development community” to create a greater sense of involvement. He said staff should not be “simply behind the wall so to speak, counting the bodies, counting the adverse events.”

Pazdur has long called for FDA to foster an academic setting and recruit candidates interested in that setting. (Also see “FDA Talent Hunt: Is Recruiting From Academia Better Than Industry?” – Pink Sheet, 30 Nov, 2015.)

FDA also wants its staff to connect with patients and other stakeholders to better understand unmet needs and treatment burden because it can enhance risk-benefit decision-making.  (Also see “US FDA Sets ‘Low Bar’ For Meetings With Patients ” – Pink Sheet, 25 Apr, 2018.)

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