Plus ça Change, Plus c'est la Même Chose (or Maybe Not)

As election day nears, there are an increasing number of news articles focused on “transition from one administration to the next.” This is a reality that faces all federal agencies -- and FDA is no exception. The nature of transition can also, ultimately, affect funding and function of federal agencies. For this reason, that is why both candidates have transition teams that are already set and organizing, and prepared to send “parachute teams” into the federal agencies quickly in the first days of the new Administration.First, it is important to stress the breadth of changes that are coming -- leadership, policies, programs, priorities, etc. -- will all be fundamentally different. There is a degree of collective amnesia about how far reaching this process is. Eight years ago (W. Bush to Obama), there were massive changes, but our memories are largely focused on the great recession and the fiscal stimulus package. Sixteen years ago (Clinton to Bush 2), there was also an extraordinarily amount of change, but our memories of that era are mostly of 9/11. One can even stretch the pattern back to 24 years ago (H. W. Bush to Clinton) and the change in government was profound. However, memories of that era focused on a failed health-reform effort.So, lesson one: expect a level of turnover and change that is beyond what can easily be imagined. Note that this will be true whether it is a Democrat to Democrat transition (Clinton wins) or a Democrat to Republican transition (Trump wins).Second, new Administrations usually want their own team. While there may be exceptions, the default position is that all political appointees will be replaced, with only a very few being retained (and even then, usually recycled into new positions). In the case of FDA, the only exception has been 1992/1993, when Dr. Kessler remained as Commissioner. Otherwise, lesson two, the norm is that the old team is out fairly quickly, career “actings” are appointed, temporary political “parachute teams” are sent in, and presidential personnel begins the process of selecting agency leadership – with the Secretary of HHS amongst the first wave of cabinet appointments.One key variable: assuming there will be changes, how long will it take for a new Commissioner to be in place? Based on recent history, the potential range is 4 months to 2.5 years. In 2009, Dr. Hamburg was nominated in February/March and she was on the job before Memorial Day. In contrast, starting in 2001, there was an acting FDA commissioner in place for 2 years and it was well into 2003 before Dr. McClellan was nominated and confirmed.In concluding, I have one story that reflects how important it is for full-time confirmed appointees to be in place. Many readers may remember the peanut butter contamination problems in early 2009 and President Obama talking (lovingly) about how concerned he was because his daughter Sasha ate peanut butter sandwiches for lunch. The back story (here) is instructive: there was an acting FDA commissioner without the standing to be a government spokesperson on this topic and there was no Secretary of HHS, Assistant Secretary for Health, or Surgeon General in place yet. Remarkably, the President of the United States was the only credible government official in place to deal with the public in a crisis that would otherwise have been handled by the FDA Commissioner. Transition can be rocky and have unexpected outcomes!Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.