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GAO Report Highlights FDA Staff Shortages for BiMo Inspections


The U.S. Government Accountability Office stated in a recent report that the FDA’s ability to fill openings in its Bioresearch Monitoring (BiMo) workforce has been impeded by several factors, such as salaries and the travel demands placed on these investigators. The report recommends that the FDA increase the financial incentives to fill these positions, although there are signs that morale among BiMo investigators is under pressure from several angles.

The report is focused on the FDA cadre for inspections of clinical trial sites for products regulated by the agency’s Center for Drug Evaluation and Research (CDER) exclusive of the agency’s other product centers. The CDER BiMo group conducted more than 800 of these inspections annually between 2014 and 2019, a number that rose to more than 900 in 2017 and 2018. The volume of these inspections fell to fewer than 600 per year between 2020 and 2022, however, principally due to the COVID-19 pandemic. As of the date of the GAO report, only 306 such inspections had been completed in fiscal year 2023, although some FY 2023 inspections have not yet been completed and reported. AdobeStock_671933899 Science, black woman and pipette with tube for test, research and investigation in laboratory. Female scientist working with dropper to study liquid sample, review solution and innovation of vaccine

The GAO made a single overarching recommendation, that the FDA evaluate its formal recruitment and retention efforts, which could include student loan repayment and increased salaries, a recommendation with which the Department of Health and Human Services agreed. The report states that the FDA has provided both these incentives in the past to help resolve the staffing problems with the CDER BiMo team, but has offered other incentives as well. The list of informal rewards and incentives includes a recognition system that can be used to obtain additional paid time off and a suggestion box that allows investigators to anonymously recommend more employee-friendly policies. However, managers at the CDER BiMo program indicated to GAO that they are not clear on which of these steps has been the most effective.

The inspection problem has arisen before as seen in a 2010 report by the HHS Office of Inspector General, which addressed inspections of clinical trials taking place outside the U.S. This report cited logistical challenges as one of the chief impediments to the conduct of those inspections, but the 2010 report offered little to no insight into agency staffing issues per se.

In 2018, the FDA had reorganized its staff to create a specialized BiMo inspection group in order to provide greater efficiency in the conduct of these inspections. In fiscal years 2018-2020, the FDA had rated only one to two percent of these inspections as official action indicated (OAI), less than half the rate of three to seven percent between fiscal years 2012 and 2017. The GAO report states that FDA officials had no definitive explanation for the change in OAI ratings, but speculated that the formation of the specialized inspectorate might have played a role.

GAO interviews with CDER’s BiMo field investigators suggests that these investigators, whose OAI recommendations can be overridden, were of the view that a greater percentage of these inspections starting in 2018 merited an OAI rating. However, this view was not always shared by FDA staff who reviewed the applications that included data from these clinical sites. The report states that the BiMo investigators have only five days to complete the paperwork for OAI inspections, much shorter than the 30 days when the inspection is rated no action or voluntary action indicated. Several of the investigators who were interviewed by GAO staff indicated that they were frustrated by the perception that some clinical site entities were not properly held accountable for the regulatory deviations seen at that clinical trial site, a significant source of distress for at least some members of CDER’s BiMo inspection team.

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