The Start of the Califf Era

In a packed room on April 19, new FDA Commissioner Robert Califf discussed his view of the agency and the priorities that represent his agenda. He expects to make the most of his time as Commissioner, balancing his own personal involvement in issues with respect and deference for expertise within the Centers.While his remarks were far-ranging (see the attached PowerPoint deck), he spent the most time discussing what he considered the most pressing issues in front of the Commissioner. Notably, he focused on an issue that is also of importance to the Alliance: expanding the effectiveness of FDA in recruiting and retaining personnel with life sciences, engineering, and information sciences backgrounds. He then touched on other issues of particular importance to him, such as generating evidence to inform decisions; precision medicine; and the implications of the President’s Cancer Moonshot initiative for FDA.Several reporters covered the Commissioner’s remarks and it is interesting that each of them took something different from his presentation.

• Dickenson’s FDA Webview headlined Dr. Califf’s priority setting and hands-off approach to management. They quote him as saying:

The Centers are there for a reason and they have really competent experts and they make good decisions.

The reporter then described Dr. Califf’s approach:

there are 16 issues that are at the level where he needs to be involved either because they are difficult problems or they are something in which he has a great personal interest.

[Note that the 16 priority issues are on slide 9 of the attached deck.]

• Stat put its focus on the juxtaposition between Dr. Califf’s confirmation pledge to not let industry too deeply into agency decision making and his statement at the Alliance about “the practical reality” of having to work with industry. They quote him as saying:

We have to be able to interface effectively with people that we regulate, which is extraordinarily touchy territory. We have to keep our sanctity of regulation, but we have to be fluent with the outside industry, as the knowledge changes so rapidly.

• Inside Health Policy focused on Dr. Califf’s call for more funding for medical device programs, particularly monies for the creation of a national device evaluation system (NMDES). The article notes that Dr. Califf pointed to the increasing complexity of medical device issues and the importance of having a Sentinel-like system in place to function as the NMDES. Sentinel only became a powerful tool, he pointed out, because Congress provided support to get it off the ground.

• Pink Sheet Daily headlined Dr. Califf’s remarks on the Cancer Moonshot, summarizing that

Commissioner Califf says review staff reorganization based on disease will go ahead regardless of what other headway VP Biden's initiative makes.”

The bulk of the article then goes on to describe some of the tensions reflected in Dr. Califf’s remarks. On the one hand, he remains committed to the quality of decision making and the importance of retaining structure ... with his assertion that a new center of excellence on clinical oncology would “not be virtual only.”

From my own standpoint, I was impressed with the breadth of the commissioner’s comments and his obvious comfort level in analytically and precisely establishing areas for Commissioner involvement and action. At the same time (and as reflected on slide 3), the Commissioner showed great awareness of the degree to which issues unexpectedly become critical to the agency and the Commissioner, whether planned for or not.If you didn’t get a chance to attend the Alliance’s briefing, I urge you to find an opportunity to attend some future event at which Dr. Califf is speaking. I think you will come away impressed, too.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.