GAO Report Recommends Retaining FDA’s Drug Inspectional Workforce As Agency Prepares for Trumpian Changes

Over the past few days, we’ve been blogging about changes that are sure to come to FDA under Trump 2.0. Calls to more generally gut Federal agencies are everywhere, including from Robert F. Kennedy, Jr., the current nominee to lead the department of Health and Human Services. But shedding regulators in sensitive areas like drug manufacturing—even in the era of influencer-driven medicine—can lead to compromises in safety and efficacy, especially when FDA is already facing a massive inspectional backlog. One occurrence where an adulterated drug leads to injury can change a lot of minds about government’s role and the extent of needed FDA oversight.

Americans’ faith in safe drugs is thanks in no small part to the FDA investigators that conduct preapproval, for-cause, and routine inspections. So what does this all mean for FDA’s inspection workforce? Perhaps presciently, the non-partisan Government Accountability Office (“GAO”) issued a report last week imploring FDA to implement strategies to retain its investigators and address a long-simmering shortfall in their ranks.

According to the report, FDA has employed between 200 and 250 investigators in the years since the COVID pandemic. Over that time the number of vacancies has steadily grown, from 25 in 2021 to 73 in 2023. Those vacancies came while FDA was trying to ramp up inspections, after they fell under the first Trump administration and then cratered during the pandemic. The task before these investigators is daunting. According to FDA data, there are over 4,700 registered drug manufacturing facilities globally, more than half overseas. In 2023, FDA conducted 906 domestic and 768 foreign inspections, still well below pre-pandemic levels. According to FDA, and as reported by GAO, the difference was due to lower investigator capacity, due to the departure of several highly experienced investigators and their replacement with largely novice investigators, who can take years to train up.

There is so little capacity because being an FDA investigator requires immense technical knowledge, almost constant travel, and long hours. Unsurprisingly then, GAO has identified turnover as the key problem plaguing FDA inspectional workforce. This is a consistent finding from GAO, which has noted in past reports that investigators face these difficult professional challenges.

Under the Biden administration, FDA has taken some steps to remedy this problem. However, GAO reports that they have been ineffective as “investigator attrition has generally outpaced hiring and has resulted in a large number of relatively inexperienced investigators.” GAO credits FDA for implementing “action plans” to address investigators’ pay and training, but notes that the agency has not yet implemented any remedies for dissatisfaction over travel, workload, and work-life balance. The report also notes that “the continued loss of experienced investigators is already affecting FDA’s ability to meet inspection goals.” Lower numbers of investigators combine with lack of experience to limit the overall number of inspections FDA can conduct. That, in turn, may compromise FDA’s ability to identify lower manufacturing standards and the failure to comply with FDA and cGMP requirements.

The report concludes that FDA stakeholders should continue to collaborate to identify strategies that appropriately address these issues. Of course, making federal jobs more appealing for current and aspiring FDA investigators is not at the top of the incoming administration’s to-do list.

Is the GAO report a Pollyanna assessment of Federal priorities in the face of the current political bent towards proposed massive cuts to Federal jobs and services? We would say certainly not, as it underscores a critical need to ensure drug safety and efficacy. You are forgiven, however, if you’re skeptical that an RFK Jr.-led HHS would ever enact these recommendations. But in the face of the prevalent headwinds, there is also some reason to believe that this part of FDA’s vital role in ensuring public health will not fall entirely by the wayside under the weight of potential cuts. Even small-government members of the Republican-controlled House have long beat the drum of increasing FDA’s foreign inspection capacity. And we can’t help but wonder if the goals of smaller government aren’t outweighed by the political consequences to an administration potentially pock-marked by recalls, shortages, and outbreaks. Those very negative outcomes may be the fate of the American gold standard of drug safety if the incoming administration decides that oversight and inspections are disposable Federal functions.