Who'll Get the Work Done ... And How Fast?

As FDA assesses the potential impact of sequestration (see the Alliance's new chart with our preliminary analysis), one particularly troubling aspect is maintaining existing personnel levels.

As the Alliance often points out, over 80% of the agency’s budget is devoted to people costs (salary, benefits, office space/rent, training, travel, information technology, etc.). An 8.2% cut in the FDA budget will be hard to absorb without reduced staffing levels or imposing furlough days.

Congress certainly understands that it has created this predicament for federal agencies. The current sequester is based on both new and older budget laws. One of the latter explicitly states in the conference report (H.Rept. 99-433): “The conferees urge program managers to employ all other options available to them in order to achieve savings required under a sequestration order and resort to personnel furloughs only if other methods prove insufficient.”

Compared to agencies with higher personnel costs, grant-making agencies (such as NIH) have more options to avoid lay-offs. For those more like FDA, there is talk of occasional agency furlough days to absorb cuts (e.g., “flight-less Fridays” caused by cuts affecting air traffic controllers; “trial-less Tuesdays” to offset cuts to the federal judicial system). These are technically possible, although it would play havoc with the economy.For those with 24/7 responsibilities, like the FBI and US Marshalls, it is hard to see how that would actually work. Nor would it work for agencies like USDA’s Food Safety Inspection Service, which operates on a “man in the plant” basis (i.e., if an inspector is not present, a meat-packing or slaughter house has to close).

FDA is caught in its own unique blend of these problems. Field inspectors are not caught in a “man in the plant” situation, but the pressure to perform more inspections is coming straight from Congress. The lack of FDA inspectors in major shipping ports (because of lay-offs or furloughs) would quickly create a backlog. Not good for safe food, drugs, and devices for Americans ... and definitely not good for American industry and the economy.

An alternative would be to concentrate furloughs or lay-offs in the product centers. This would mean slower product approvals, delays in producing industry guidances, and curtailment of important initiatives like regulatory science, nanotechnology, diagnostics, etc. This would be bad for patients and consumers, bad for industry, and bad for the economy.

So to the general and severe consequences FDA would incur under sequestration, one must also add: if furloughs or lay-offs become necessary, who will be getting the work done and how much slower and less safe will the outcomes be?

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.