FDA says it's making recruitment strides, but problems with overseas inspections persist

Amid pandemic-fueled delays to the FDA’s manufacturing inspection work, staffing issues have emerged as another sticking point for the regulator. While the agency seems to have made good progress on hiring in the past 12 months—even picking up a few lessons courtesy of COVID-19—there’s still much work to be done, especially when it comes to agents overseas.

As of Monday, the FDA had 56 open job postings on USAjobs.gov, a significant drop from the 416 vacancies the agency had listed on the website about a year ago. The listings run the gamut from physician posts and consumer safety roles to those for program analysts, statisticians and regulatory counsel.

The hiring push comes more than five years after the FDA first put its own recruitment practices under a microscope. Between November 2017 and December 2021—the month the FDA published its Final Hiring and Retention Assessment Report—the agency says it’s made “considerable strides in its recruitment, hiring and retention functions.”

From June 2020 to December 2021—as COVID-19 first started raging around the world—FDA says it “worked to address many recommendations and implement improvement activities” to boost conscription.

Despite those efforts, however, “FDA continually has critical vacancies to fill,” Audra Harrison, a press officer at the FDA’s media affairs branch, told Fierce Pharma.

Hiring for the 'new normal'

The FDA admits in its 2021 employment report the COVID-19 pandemic “fundamentally altered ... recruiting, hiring, and retention activities,” noting that it adopted an “all-hands-on-deck” approach to fill “urgent, high priority positions and to handle an intense surge in workload.”

Even still, there’s been a silver lining to the pandemic’s employment squeeze: While new hiring and retainment measures like remote work and virtual recruitment were “largely unplanned and provisional,” they also offered a “test environment” to demonstrate how the FDA could adopt to “completely new ways of working,” the agency said in its report.

The pandemic has landed its fair share of hits against the FDA, too—most notably derailing the regulators’ inspection activities overseas. Still, COVID-19 isn’t entirely at fault for the agency’s staffing issues.

In fact, foreign inspections have been a pain point for the regulator since before 2020, Mary Denigan-Macauley, director of healthcare at the Government Accountability Office (GAO), said in an interview last year.

Given the “rigorous nature” of FDA’s foreign cadres—its teams of U.S.-based investigators that run inspections overseas—the agency “continues to face challenges recruiting investigators,” said Harrison, who cited foreign travel restrictions as one potential hurdle for applicants.

The GAO, for its part, has been pushing (PDF) the FDA to sort through its inspection backlog and leverage alternative inspection tools like remote visits, record requests and increased collaboration with foreign regulatory bodies.

In light of the GAO’s recommendations, “[t]he FDA is reviewing current hiring and retention processes,” Harrison said. In turn, the FDA hopes to both recruit and develop new talent as well as to retain its current cohort of foreign drug investigators, the FDA press officer explained.

One way the agency is attempting to do that is by exploring alternate hiring strategies and different “compensation methodologies," Harrison said. Plus, the regulator is planning a recruitment effort focused on enlisting bilingual drug investigators, Harrison added.

“FDA will also continue to look for ways to optimize use of available retention incentives, such as the Student Loan Repayment Program, monetary recruitment and retention incentives and time-off incentive awards,” she continued.

Righting the ship overseas

Alongside the recruitment push, the FDA is working to increase the number of site visits abroad in places where it's allowed to travel, according to the U.S. Department of State and the Centers for Disease Control and Prevention, Harrison explained. The agency has continued to carry out mission critical inspections in places like India and China, and, in April, FDA started conducting prioritized inspections in various regions. 

Elsewhere, a global pandemic and difficulties recruiting foreign cadre members haven’t been the only impediments to the agency’s recruitment. One potentially overlooked hurdle? The FDA is having to compete for talent with the biopharma industry itself, plus schools and other government agencies, Harrison said.

“Competition for high-value, qualified candidates from other public health organizations at the federal, state and local levels, the private sector and academia continues to be a challenge,” Harrison said.

Meanwhile, the FDA’s trouble tackling inspection and oversight duties during the pandemic has bled into 2022, according to a June report. As the coronavirus has spread, evolved and settled in, the regulator has at several points had to pause site visits at home and abroad. Twice last year it signaled concerted efforts to get its oversight back on track.

An anonymous former FDA official told Stat the recently disclosed shortfalls represent “a pretty significant drop" and could have “real-world implications.”