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# GAO Report Hits FDA on Investigator Retention
- URL: https://www.fdaweb.com/gao-report-hits-fda-on-investigator-retention/
- Published: 2024-03-25T12:00:00.000Z
- Updated: 2026-09-14T14:26:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156624

A new Government Accountability Office (GAO) [report](https://www.gao.gov/assets/d24106383.pdf?ref=fdaweb.com) says FDA needs to evaluate its recruitment and retention efforts to support and maintain its investigator workforce. The report notes that FDA has faced challenges recruiting and retaining investigators, “resulting in fewer inspections and a less experienced workforce. For example, FDA was unable to complete about 30% of clinical investigator inspections, which account for the majority of clinical research inspections the agency conducted during 2018 through 2023, because they needed extensions beyond the CDER-requested due date.” The report says FDA acknowledged delays in “inspections of other entities such as IRBs, which are inspected for surveillance purposes rather than from the review of marketing applications.”

GAO talked with FDA officials and investigators who said low compensation and high amounts of travel contributed to ongoing retention and recruitment challenges. “The agency recently made progress recruiting new investigators, but attrition has been a persistent problem and it can take new investigators up to a year to independently conduct inspections,” the report says, adding that FDA has not formally evaluated its retention/recruitment efforts to determine their effectiveness. “Such an evaluation could help FDA determine whether it is using the most appropriate tools to maintain its workforce. GAO has cited workforce as a concern across multiple FDA programs and sustained attention in this area will be critical.”

GAO also hinted that other frustrations could affect investigator attrition. “For example, FDA classified few clinical research inspections as having serious deficiencies that would warrant regulatory action, though many of the 15 BIMO \[bioresearch monitoring\] investigators we spoke with expressed frustrations that their classification recommendations were changed to a less serious classification,” GAO says. “In addition, both BIMO investigators and FDA officials stated that, for certain types of studies supporting generic drug applications, agency regulations limit the deficiencies that can be cited in inspections. FDA is in the process of revising these regulations.”

Additionally, GAO says FDA inspection data show that BIMO investigators in ORA recommended that more clinical research inspections be classified as “Official Action Indicated” than eventually received that grade because reviewers in CDER subsequently classified them as less serious than their initial classification. “Specifically, from fiscal years 2012 through 2020, CDER reviewers classified nearly 60% of clinical research inspections that BIMO investigators in ORA initially recommended for Official Action Indicated classification as a less serious final classification,” GAO says.