The U.S. FDA should audit the hiring practices of its Bioresearch Monitoring (BIMO) program to see whether efforts to attract more investigators and boost drug trial oversight are paying off, particularly as retention has largely failed to improve, according to a report published March 25 by the Government Accountability Office (GAO).
“Although the FDA has taken steps to increase recruitment and address retention, the agency does not know which of the various efforts have been effective,” the GAO wrote in its report, adding later that a sufficient number of BIMO investigators and more experienced workforce play an important role in assuring the quality of clinical research data used to approve drugs.
Acting on a request from Congress, GAO reviewed FDA clinical trial inspections from fiscal years 2012 through 2023, combing through agency data and interviewing officials on their recruitment practices. The government office also interviewed 15 of around 100 authorized BIMO investigators, selecting individuals with a variety of positions and tenures at the FDA.
The FDA has struggled to find and especially to keep investigators who carry out BIMO activities, which include data audits, on-site inspections and remote assessments, according to the GAO report. Agency investigators and officials who spoke with the GAO blamed historically low compensation and frequent travel requirements for turning off would-be hires. In 2022, the FDA bumped up its salary range for investigators and began offering to pay up to $60,000 of student loans for employees who remain at the agency for at least three years.
While this has led to some improvement in recruitment, “attrition remains a persistent problem,” the GAO said. In 2023, the FDA hired 23 investigators but saw 11 depart—the same number that left in 2018, a year when the agency had hired only three, according to the report. Of the six years between 2018 and 2023, hiring outpaced departures in only two of them.
On top of that, the FDA may lack a clear picture of just how well hiring efforts are paying off, as the agency hasn’t officially audited them. Though agency officials told GAO that they discuss recruitment efforts weekly and have begun reviewing employee exit survey data to see why BIMO investigators leave, there hasn’t been a formal look into what’s working and what’s not.
“Such an evaluation could help FDA determine whether it is using the most appropriate tools to maintain its workforce,” the GAO said.
The report noted that a shortage of investigators and an inexperienced workforce has sometimes maimed the agency to the point of inefficiency. While COVID-19 could absorb the blame in some regards, the problems predate the pandemic. For example, between 2018 through July 2023, the FDA was so understaffed that it failed to complete 30% of an undisclosed type of common inspections on time, GAO auditors found.
The U.S. Department of Health and Human Services, under which the FDA operates, agreed with the GAO’s recommendation that the agency evaluate its hiring and retention efforts, the report said. In a response to Fierce's request for comment, the FDA stated that it agrees with GAO’s recommendation and is currently developing an action plan.
Editor's note: This article was updated on March 28, 2024, to add a statement from the FDA.