The move to link inspectors to specific organizational units (i.e., drugs, devices, biologics) to more closely align with the Centers responsible for the products seems to have taken a turn back to a more generalist approach. According to a Pink Sheet article (here, subscription required) authored by Sarah Karlin-Smith and Derrick Gingery, the so-called “‘Simple Reform’ initiative would reverse a 2017 move to ensure FDA investigators were experts in the commodity they inspected or in clinical research regulations” to a more generalist role as opposed to the “program alignment” that placed inspectors within specific program areas of expertise.
With the FDA’s staffing cuts, this move may make sense as it will provide staffing flexibility to cover the various product areas as needed. The current administration appears to be looking to reduce headcount. Generalists will be more cross-functional but less effective in areas that require special expertise. It is likely that experts in certain topics like cell and gene therapy, complex biologic products, or complex drug device combinations will still concentrate in their respective specialty areas but will also be used to provide training to new inspectors.
If one thing is certain these days, it’s that if you don’t like a specific reorganization, you just need to wait a hot minute and a new one will come along. Hopefully the Agency’s return to the generalist paradigm will not slow down required interactions with various FDA Centers and the ability to clear warning letters or close out FDA Form 483s observations in a timely manner.
