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The Prompt Confirmation of a New Commissioner

January 29, 2016

A number of media calls came in this week asking: what does the Alliance think about Dr. Califf’s chances of being confirmed as the FDA commissioner?

The question was largely prompted by Senator Manchin becoming the fourth Senator to place a hold on the nomination. He is concerned about FDA’s failure to address the opioid abuse epidemic and he is also critical of Dr. Califf’s past work with industry. Senator Markey’s hold is about opioid abuse and Senator Sanders’ is about Dr. Califf’s past relationship with industry, as well as drug pricing. The only truly different hold — from Senator Murkowski, the lone Republican expressing concerns — is about whether FDA will adopt mandatory labeling of GMO salmon.

This is by way of background to the main focus of this week’s column: why the Alliance is tracking the confirmation process.

First, I should be clear that the Alliance does not have a position on who the commissioner is. We stick to FDA appropriations and related resource questions. However, going back to the beginning of the Obama Administration, the Alliance board has twice directed staff to be advocates for the prompt naming and rapid confirmation of the President’s choice for FDA commissioner.

Resource decisions and advocacy for the agency’s budget is significantly more effective when done by a confirmed commissioner. This has nothing to do with the leadership of those who are “actings,” but rather reflects a government-wide reality that those who are acting are treated as short-timers and have less opportunity to speak out. By the very nature of their temporary appointment, they cannot commit to what the agency will do in the future.

The sooner that FDA has permanent leadership, the smaller the gap in identifying the medium- and long-term priorities of the Agency and the resource needs for achieving those priorities. In Dr. Califf’s case, the length of the process didn’t seem to be a problem, although there was some delay clearing conflicts of interest. The threat of Senators’ holds is potentially more damaging, especially if more months go by without a confirmed Commissioner.

The vigor with which an Administration identifies and nominates an FDA commissioner can be highly variable and is an issue. Commissioner Hamburg was nominated and confirmed in about 5 months. However, there was a gap of almost 2 years before Commissioner McClellan was sworn in at the beginning of the second Bush presidency. I can envision this will be relevant next Spring, as we discover anew whether appointing an FDA commissioner (or renewing the existing one) is a priority of the new Administration.

While we respect the conversation the Senate is having regarding Dr. Califf’s nomination, we encourage a speedy deliberation.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.

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