Strong Leadership on Resources Essential

We are only 3 weeks into the new Trump Administration, HHS Secretary Price is only just coming into office, and the FDA commissioner, even if nominated on Monday, is unlikely to be on the job before mid-April. Yet, even with only a few of the players in place, a pattern is emerging.The President uses an Executive Order or Presidential Memorandum to implement or advance one of his campaign promises. The order is sweeping, befitting a campaign but not necessarily attuned to the task of governing. This is followed by guidance from OMB that tries to bridge the gap -- fulfilling the campaign promise and having as much impact as possible, while reflecting the realities of government. This is, in turn, followed by department-level guidance that applies the goals of the larger initiative to the specifics of orderly governing.Interestingly, once the departmental guidance and structure are in place, the process reverses. Instead of top-down direction from the President, the main action becomes bottom-up, with agencies flowing their needs and perspectives to the department and OMB for consolidation into government policies. Top-down, followed by bottom-up, is how both the hiring freeze and the regulatory cutback initiative are structured.This is, in fact, the way the President’s budget request is put together every year. Offices and centers at FDA develop proposals for their dollar and manpower needs for the upcoming fiscal year. At each level upwards, the FDA’s proposals are consolidated, amended, and prioritized and the agency gets less and less of what it needs. At the end, each department and agency is given a “passback” from OMB and has a last chance to advocate for items that didn’t survive the process.What does this have to do with FDA and its need to survive and grow in an environment where its jobs, budgets, and regulatory output will be subject to strong downward pressure? In my view, this highlights the need for the Commissioner to be the agency’s strongest advocate.Within the bounds of reasonableness, the agency must ask for everything it needs to fulfill its mission. It would be unusual, perhaps nearly unprecedented, for the Secretary to insert resources that the agency didn’t ask for. Likewise, it is important for the Secretary to be an advocate for the agency because OMB is not going to insert resources that the Department didn’t ask for. At every stage, when critical items are not agreed to, it is the Commissioner first and then the Secretary who must push for reconsideration and make the case for exceptions.One of the challenges for the Alliance and the FDA stakeholder community is to help the Secretary and the Commissioner to understand and appreciate FDA and become willing advocates for its mission and needs. We start with a Secretary who understands how government works, but in his leadership of the House Budget Committee had little or no involvement with the broad sweep of FDA’s jurisdiction. Likewise, we cannot assume that a new Commissioner will understand why advocacy for the agency is so important ... unless we make the case that strong leadership on resources is an essential part of the Commissioner’s role and the success of his tenure.Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.