GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

March 29, 2024By John W.M. Claud & Kalie E. Richardson

While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. Inspections went down—way down—during the pandemic. In March 2020, FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections. Many have noted that FDA has been slow to recover

We’ve blogged before on FDA’s post-pandemic inspection work, writing about the resumption of both good manufacturing practice (GMP) and bioresearch monitoring (BIMO) inspections. And a look at FDA’s Data Dashboard for Inspections reveals that the Agency is returning to pre-pandemic numbers. But gaps still remain. In 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program. That report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony.

More recently, GAO has published a new report on FDA inspections entitled “FDA Should Evaluate Its Efforts to Recruit and Retain Its Inspection Workforce.” According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. These are BIMO inspections of hospitals, clinical research organizations (CROs), and other similar facilities where clinical trial work is performed. The vast majority are for drugs.

GAO reports that BIMO inspections peaked in 2017 when FDA was able to complete over 970 visits. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022. In other words, the inspectional output was inversely proportional to the importance of clinical research.

The Agency told GAO that the root of the problem was not having enough investigators. These positions suffer from high turnover due to low pay and frequent travel. But of course, a happy inspectional workforce is vital to this foundational part of FDA’s approval mission.

Thus, the findings from GAO that FDA needs to nurture and maintain is clinical inspection force are significant. And the problems identified—salary and travel—are entirely predictable and mirror issues plaguing the entire inspection force. GAO concludes that FDA need to monitor this personnel situation, noting it has cited workforce retention and satisfaction “as a concern across multiple FDA programs and sustained attention in this area will be critical.”

The report comes at a time when FDA is trying to map out how it wants to exercise the authority it has over clinical trials. In December, Commissioner Robert Califf wrote about the importance of transparency in trials, noting the FDA takes a risk-based approach to compliance and enforcement. He also said that notices alerting firms of noncompliance were, in the Agency’s view, highly effective in correcting clinical sites’ practices.

The stakes remain high, though. The Department of Justice has obtained several convictions for fraud in clinical trials, and drug approval sponsors face mighty obstacles if they do not conduct and maintain the appropriate due diligence on CRO’s and clinical sites. We see the risks when we conduct due diligence for clients and ignoring them only serves to put drug sponsors seeking approval at the top of FDA’s list when it’s looking for ways to prioritize its inspection choices.