This week, Washington was all about confirmation hearings and repealing the Affordable Care Act. … READ MORE …
According to the December 29th issue of the Washington Post, Dr. Califf has not heard from the transition team and it is likely that the new Administration intends to appoint their own FDA commissioner rather than retain him. While this has not been announced and must be considered purely speculative, it would not be unexpected since the last two incoming administrations chose to appoint their own commissioner. If true, the Alliance thanks Commissioner Califf for his service to the agency. His leadership, particularly on the need for additional resources for the agency, have been an essential part of FDA’s recent successes.
If there is going to be a new commissioner, the process is likely to occur over several months. Upon the departure of a commissioner, an “acting” is appointed to run the agency until a new commissioner is confirmed. For example, between Dr. Hamburg’s departure and Dr. Califf’s swearing in, Dr. Ostroff served as the acting commissioner. Since he is currently the deputy commissioner for food and therefore available, it is plausible that he will be asked again to be the acting commissioner.
The timing of the rest of the process depends on when the new Administration announces their candidate and how long the confirmation process takes. For comparison purposes, 8 years ago, at the beginning of the Obama administration, Dr. Hamburg was nominated in mid-March 2009 and sworn in by mid-May. Sixteen years ago at the beginning of the Bush administration, the position was vacant for a number of months and Dr. McClellan didn’t take office until November of 2002.
This time, the expectation is that the incoming Trump Administration will want to appoint a new commissioner quickly, perhaps even this month. Based on the experience 8 years ago, tack on about 2 months for the Senate HELP committee to vet the nominee and hold a confirmation hearing and for a full Senate vote to be held. Faster is always possible, but things also may be slowed by the large number of appointees who need confirmation by the Senate.
The Alliance hopes a new commissioner (assuming there will be one) will be an advocate for meeting the funding and personnel needs of the agency. FDA has a sweeping mandate, but not the resources to fully accomplish it.
Beyond that, the Alliance has one other priority: the speedy appointment of a new commissioner once the position becomes vacant. One can argue about the reasons why it is so, but there is general agreement that FDA does not run as well when it lacks a confirmed commissioner. In particular, an acting commissioner (by the nature of their position) is limited in his or her ability to be a successful advocate for the agency’s resource needs.
To be clear, the Alliance does not promote or endorse specific candidates for FDA commissioner. Our members can do that if they so choose, but it is beyond the scope of our broad coalition. Our position with regard to a new commissioner is solely focused on the rapid confirmation of a new commissioner once a vacancy occurs. The immediate appointment of a new FDA commissioner will provide direction to the agency and its staff, reassurance to the American people, and continuity for the stakeholder community.
Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.