The FDA’s Bioresearch Monitoring program has seen a 45% decline from fiscal 2017 in the number of inspections it does on clinical drug trials using human subjects.

The FDA’s Bioresearch Monitoring program has seen a 45% decline from fiscal 2017 in the number of inspections it does on clinical drug trials using human subjects. simarik / Getty Images

FDA clinical inspections are plummeting due to staffing issues

Employees are also concerned some of their inspection findings are being ignored.

The Food and Drug Administration is inspecting far fewer pharmaceutical companies conducting clinical research as it adjusts to the post-pandemic world and a smaller workforce, which an auditor warned is leading to less informed drug approvals. 

When FDA employees do conduct inspections, their recommendations for findings of “serious deficiencies” in the research process are typically being downgraded. Inspectors told the Government Accountability Office that is leading to frustrations within the workforce and drug companies not being held accountable. 

FDA’s Bioresearch Monitoring program completes inspections when researchers conduct clinical trials and other studies with human subjects, which can take place domestically or across the world. The inspectors oversee the quality and integrity of the research, which companies use to support FDA approval of a drug being marketed in the United States. Inspectors go on-site to conduct their investigations, which can call into question the data in the companies' applications pending before the FDA or identify risks for human subjects. 

The agency conducted just 537 such inspections in fiscal 2022, a 45% decline from its peak in fiscal 2017 despite the number of applications before the agency remaining consistent. Some of the slowdown was due to the COVID-19 pandemic: FDA paused non-essential inspections in March 2020 and did not fully restart them domestically until July 2021. GAO noted, however, the Bioresearch Monitoring program typically considers its inspections essential and it still conducted 354 fewer inspections in fiscal 2022 than it did in fiscal 2019. 

“As a result of conducting fewer inspections, FDA may have less information to inform its review of marketing applications and surveillance of ongoing clinical research,” GAO said. 

During the pandemic, FDA started conducting some remote inspections. Of the reduced number it completed, 321 were not done in person. Most inspectors told GAO the remote investigations were inferior as, for example, companies could edit or create documents after inspectors requested them. The agency is planning to continue remote inspections, despite the employee reservations. 

GAO also found that while around two-thirds of clinical researcher applications before the agency come from work being done in foreign countries, most inspections occur domestically. FDA officials said it is a more efficient use of time and “finite inspection resources” to take that approach.

Additionally, FDA is increasingly not conducting random inspections or launching investigations when issues are flagged to the agency. It is instead prioritizing pharmaceutical companies’ pending applications, which agency officials said prevents delays for those paying user feeds that fund much of its work. 

FDA has maintained staffing issues in its inspection workforce since 2018, GAO said, with attrition consistently outpacing recruiting. From fiscal years 2018 to 2022, the clinical research inspector workforce declined by 20%. The agency made some progress in hiring in fiscal 2023, but the total staffing level is still below 2018 levels. And even with the higher number, FDA officials said the agency needs to double its workforce to meet inspection demands. 

Attrition has hovered around 13% since fiscal 2018, which inspectors attributed to the significant travel and low pay leading employees to take better-compensated jobs in the pharmaceutical industry. While FDA has made some hiring progress recently, it can take years for employees to be trained up to conduct their own inspections. The agency boosted pay for the roles and is offering student loan repayment of up to $60,000, but attrition has remained high. It also has fewer authorized positions due to stagnant funding and high salary costs. 

GAO recommended FDA evaluate its recruitment and retention of the investigators, to ensure it is using the most effective tools to address its staffing issues. The Health and Human Services Department agreed with the suggestion and said it would incorporate its findings from that review into its workforce strategy.

“Having a sufficient number of [Bioresearch Monitoring] investigators and a more experienced workforce is important for the oversight of the clinical research that helps to assure the quality of the data used to approve the brand and generic drugs that Americans consume every day,” GAO said. 

Employees voiced frustration to GAO that their recommendations for regulatory action when their reviews found research was out of compliance were often ignored. Such suggestions, which require additional work to complete and validate, were downgraded in 60% of instances. Such recommendations were already fairly rare, occurring in only 3% of inspections between fiscal years 2012 and 2020. The rate began to decline in fiscal 2018, though officials were not sure why. 

That led some inspectors to tell GAO they were concerned “that some clinical research entities were not being held accountable.”