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“First, do no harm”

July 24, 2018

In the Alliance’s decade-long effort to increase FDA appropriations and promote understanding of the agency’s important mission, we have never had such broad support from Administration and Congressional policymakers. The agency is far from problem-free, but most public discourse in DC about FDA has a positive tone. Among other things, this is reflected in the House and Senate appropriations committee numbers for FDA for FY 19. If the conferees take the best of both bills, the agency is in line for a very nice boost in funding and the go-ahead for a number of important forward-seeking initiatives.

However, FDA funding, by itself, cannot get the job done unless the agency has a hard-working, well-trained, highly paid workforce that has a sense of purpose. In a prior column, I described it this way:

FDA’s work is labor-intensive — there are no widgets to sell and very little dispensing of grants. FDA’s staff are what makes FDA succeed. They need salaries and benefits, workspace (rent), IT, training, and travel. These costs are often higher than for other agencies because FDA’s workforce needs to be better educated to deal with medical, scientific and public health issues.

In this Administration, HHS and OMB have spoken highly of the FDA workforce and have been supportive of initiatives to improve recruitment and retention. Nonetheless, we have been concerned that changes in government-wide personnel policies might inadvertently undercut the gains at FDA that enjoy near-universal support.

For example, earlier this year, we reported on a newly released third-party report on federal worker pay. While the numbers in the analysis were presumably accurate, they were accompanied by a commentary that contained a lot of innuendo about whether the federal government needs so many highly paid workers. At the time, we said:

… while not directed at FDA, the report is a strong reminder to the stakeholder community that we need to keep talking about the rationale for FDA to have a workforce that has the right training and the requisite knowledge to do jobs that are often far more complex than they might seem to an outside observer.

Ergo, FDA can justify — if given the opportunity — why it might have higher employee costs per FTE compared to other agencies with less scientific, medical, chemical, public health, and technical responsibilities. Likewise, inspection responsibilities mean FDA will always need more travel funds than most agencies; pre-market reviews of drugs, devices, and some other products mean that the agency will always need more biostatisticians, epidemiologists, PhDs, and MDs than most agencies, and so on. While the Alliance doesn’t often talk explicitly about “FDA exceptionalism compared to other federal agencies,” we can definitely make these arguments if called upon.

Some of these issues have become the subject of labor-management negotiations within the Executive Branch and a lawsuit … and, accordingly, the Alliance will not be taking sides and we will need to give a wide berth to some of the specific issues. However — given the growing support of FDA and increased understanding of its mission — we hope those discussions are fruitful and that all parties keep in mind the central tenant of medicine: “First, do no harm.”

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