Ensuring an Effective and Motivated Workforce

As dedicated readers know, one of my favorite themes from 2017 was the incredibly positive changes at FDA over the last decade. The key thought: there was nothing wrong with “your father’s FDA,” but the agency has matured a lot since then. In the face of a significantly larger mission, the agency has made profound improvements in process, attitude, and personnel. Altogether, it reflects extraordinary progress in becoming a 21st Century regulatory agency.As a result, I am greatly optimistic that FDA will accomplish a lot in 2018. In particular, I am looking forward to seeing the benefits of ongoing efforts to expand and strengthen the FDA workforce and to reduce the number of vacancies. These efforts were given a strong boost by the 21st Century Cures legislation (December 2016) and prioritized by Commissioner Gottlieb (July 2017).No issue is more pivotal to FDA’s success than its ability to recruit and retain a highly-skilled and highly-educated workforce. Without the right people, monies cannot be used effectively by FDA.To be clear, this is not just about physicians and scientists, but also about inspectors, program manager, lab workers, and so on. Many are highly compensated and many (at all pay levels) could command better salaries and benefits in the private sector. Right now, as well as in the years ahead, FDA will need many more such individuals at every level throughout the agency -- in food programs, as well as in medical product programs.Anything that makes it more difficult for the agency to add expertise to its workforce ... is threatening to the agency’s ability to carry out its many public health responsibilities in a timely fashion.Thus, the Alliance is an advocate for FDA’s budget and FDA’s workforce ... because both types of resources are needed for the agency to meet public and Congressional expectations. We consider it our business to constantly remind policymakers that strengthening FDA means people as well as dollars.In about a month, OMB will release the President’s budget request for FY 19 and the annual cycle will begin. We expect the Administration will propose cuts at FDA - -either outright and/or by renewing its FY 18 proposal to replace BA (taxpayer) funding with more user fees. In contrast, we believe that both HHS and OMB appreciate the importance of the FDA workforce and we do not expect any personnel proposals other than adjustments to reflect proposed funding levels.Nonetheless, a newly released analysis of federal worker pay may well foreshadow the President proposing government-wide changes in federal employment policies. The report is supposedly “just the numbers” and made available in furtherance of government transparency (not itself an issue in my view). However, the accompanying commentary contains a lot of innuendo, especially about whether the federal government needs so many highly paid workers. 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.Ladd and I wish all of you a happy, healthy, prosperous, and peaceful New Year. We hope to work even more closely with each of you in the months ahead.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.