Retention of BIMO Investigators a Major Inspection Issue for FDA, GAO Report Says
The recruitment and retention of Bioresearch Monitoring (BIMO) program investigators has been a thorn in the side of the FDA that’s negatively impacted trial inspections, a Government Accountability Office (GAO) audit has found.
Writing that it’s critical for the agency to take a hard look at its staffing approach to gauge effectiveness and areas for improvement, the report points to low compensation and grueling travel demands as some of the challenges in hiring and retaining BIMO investigators.
The GAO spoke with FDA officials and 15 BIMO investigators in its study of the program. The staffing shortage has led to fewer inspections, less experienced inspection personnel and an inability to conduct all planned inspections, those interviewed said.
Struggles persist despite the FDA’s efforts to combat them through boosted compensation incentives and student loan repayments. Investigators continue to leave the agency, and new hire training can take up to a year, the GAO found.
Despite a big hiring effort last year to fill empty spots in the BIMO investigator workforce, more than 20 percent of which were newly hired staff, there were fewer inspections in FY 2023 compared to FY 2018, the report shows.
“Although FDA made progress, the agency has not formally evaluated its efforts to determine [its recruitment and retention efforts’] effectiveness. Such an evaluation could help FDA determine whether it is using the most appropriate tools to maintain its workforce,” the report reads. “GAO has cited workforce as a concern across multiple FDA programs and sustained attention in this area will be critical.”
The federal audit also identified another major point of contention among clinical research investigators: the FDA’s low numbers of major deficiency classifications deserving of regulatory action. Many of the investigators who took part in the audit were irritated that their classification recommendations were downgraded to less serious ones, the government watchdog discovered.
In total, the agency’s own data reveals that from FY 2012-2020, the FDA labeled just three percent of clinical trial inspections as official action indicated, and in FY 2018-FY 2020, official action indications dropped by about half (1 to 2 percent yearly, down from 3 to 7 percent yearly in FY 2012-2017).
“FDA officials could not state a specific reason for this change but noted several factors that could have led to it, including a reorganization in [FY] 2017 that made BIMO a separate inspection program with its own dedicated investigators with more expertise in how to conduct clinical research inspections,” the GAO said. “FDA officials also noted an evolution with regards to [GCP] monitoring that was occurring around this time, and which could have improved clinical research entities’ compliance with clinical research best practices.”
In addition, investigators and FDA officials both noted the agency’s limited authority to cite deficiencies when it comes to bioavailability/bioequivalence (BA/BE) studies. A revision of these regulations is currently in progress, the report says.
The GAO says it will follow up with an update once it has seen what actions the agency has taken in response to the report.
Access the full report here.
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