GAO report recommends FDA evaluate how it recruits, retains BIMO investigators

The US Food and Drug Administration (FDA) should examine its methods for recruiting and retaining Bioresearch Monitoring (BIMO) investigators, according to a recent report from the Government Accountability Office (GAO).

“The Commissioner of FDA should evaluate its recruitment and retention efforts for BIMO investigators—such as increased pay, student loan repayment, and other financial incentives—to determine their effectiveness and incorporate results of this evaluation as appropriate to help ensure the agency is using the most appropriate tools to maintain its BIMO investigator workforce,” the authors of the report wrote in their recommendation.

Although clinical research inspections were at an all-time high in 2017, the number of inspections has decreased since, and this is partly due to the COVID-19 pandemic a lack of investigators, the report said. In addition, 3% of clinical research inspections conducted between 2012 and 2020 were classified as having “serious deficiencies” where FDA would take regulatory action.

As part of its report, GAO interviewed officials from the Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) as well as 15 domestic and foreign BIMO investigators.

While there were few inspections that contained recommendations for regulatory action, GAO noted frustrations on the part of investigators who said their recommendations were changed to less serious classifications. This can result in additional work for BIMO investigators when supporting more serious classifications, such as gathering more evidence or further conversations with ORA and CDER officials to support regulatory action.

“According to FDA inspection data, BIMO investigators in ORA recommended that more clinical research inspections be given an official action indicated classification than eventually were, but reviewers in CDER classified many of these initial recommendations as a less serious final classification,” the report stated. “Specifically, from fiscal years 2012 through 2020, CDER reviewers classified nearly 60 percent of clinical research inspections that BIMO investigators in ORA initially recommended for official action indicated classification as a less serious final classification.”

Investigators and officials at FDA also said there were agency regulations in place to “limit the deficiencies that can be cited in inspections,” such as in studies of certain generic drug applications. Some of these regulations do not contain requirements, like in the case of record retention and following study protocols for bioavailability and bioequivalence studies.

FDA said reasons some deficiencies may not result in regulatory action include a lack of applicable regulation, and limited options for regulatory action. However, it has acknowledged these limitations with regard to bioavailability and bioequivalence regulations and is in the process of proposing a draft of revised regulations.

In terms of recruiting and retaining investigators, FDA has cited issues since 2018 with retaining BIMO investigators, “leading to a less experienced workforce and fewer inspections being conducted.” When interviewed, BIMO investigators and FDA officials said low compensation and travel were contributing to attrition in the workforce.

“While the agency has made changes to increase salaries for new hires, FDA officials acknowledged that compensation continues to be a challenge for existing BIMO investigators because the agency is not able to match industry salaries,” the authors of the GAO report said.

Regarding travel, BIMO investigators interviewed said it can take several hours to travel to local sites on top of the time for the inspection itself, and FDA notes BIMO investigators can spend up to 50% of their time traveling as part of their job.

While the average BIMO investigator attrition rate is 13%, with an 18% vacancy in 2022, there were six vacancies as of November 2023 as part of a large hiring initiative during that year, according to the report. FDA has also offered incentives to join the BIMO inspector workforce, such as student loan repayment of up to $10,000 per year, and incentives for conducting foreign inspections. However, the vacancies have resulted in 6% of clinical research inspections between 2018 and July 2023 not being completed, GAO said in the report.

Due to the large hiring initiative in 2023, over 20% of the BIMO investigator workforce is new, the GAO report stated, and it can take more than a year before a new hire can conduct basic clinical research inspections on their own and 2-3 years before they can conduct foreign inspections on their own.

“Although FDA has taken steps to increase recruitment and address retention, the agency does not know which of the various efforts have been effective,” the authors said. Performing an evaluation of which efforts have worked to recruit and retain BIMO investigators would help identify whether the agency is using “the most appropriate tools” to bridge the gap in the number of BIMO inspections being conducted, they noted.

“These challenges are not unique to the BIMO program, and workforce has been a concern across multiple FDA programs, contributing to FDA’s oversight of drugs and other medical products being included on our High-Risk List. Therefore, sustained attention from the agency in this area will be critical,” the authors said.

GAO report

GAO report recommends FDA evaluate how it recruits, retains BIMO investigators

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