Congratulating Dr. Califf; Reviewing the challenges of the confirmation process.

The Challenges of the Confirmation Process

Congratulations, Dr. Califf, upon your confirmation. The entire stakeholder community looks forward to working with you again. Please be the champion for FDA resources—staff and funding—that you were during your previous term.

Special thanks to Dr. Woodcock for running a steady ship over the last 13 months, for her career-long devotion to the FDA, and for continuing to serve the public by taking on the role of Principal Deputy Commissioner.

I believe that the Califf/Woodcock team provides a combination of agency knowledge and leadership skills that is incredibly promising for the American people and for us as stakeholders.

Not surprisingly, there were a lot of press calls this week. We received thoughtful questions to which we had some good answers that we thought should be shared.

For example, we were asked a lot about the consequences of Dr. Califf’s close vote in the Senate. To this we responded:

“There is no such thing as ‘barely confirmed.’ When Dr. Califf is sworn-in, he will be the Commissioner of FDA with all of the authorities and responsibilities of the office.”

We were also asked: what are the consequences of the many promises that Dr. Califf made to various Senators. That provided an opportunity to present the context.

“The confirmation process inherently involves ‘give and take’ between nominees and Senators. That is how the process works and is not limited to FDA. All nominees make commitments 1/ at their hearings, 2/ in responses to written questions, and 3/ in public and private meetings prior to confirmation.”

There were questions about what Dr. Califf’s should do first. Rather than focus on pending decisions, we focused on the opportunities for Dr. Califf to demonstrate leadership on behalf of the FDA. Two examples came readily to mind:

• Renewed attention to the needs—and benefits—of data and technology modernization at the agency

• Vigorous support for FDA staff who have been working non-stop for two years without any break

As we talked to reporters, we had the opportunity to explain that long gaps between Senate-confirmed FDA Commissioners are common and have been mostly caused by long delays in submitting nominations to the Senate. Once nominated, the confirmation process has typically taken about two to four months (which has been the case for Dr. Califf).

We were asked about the Alliance position on confirmation of FDA commissioners. We were able to respond:

“Because we have a broad-based membership, with diverse interests, the Alliance has never advocated for any specific person to be nominated and confirmed. Instead, our consistent position over the last 15 years has been to urge “quick nomination and quick confirmation.”

The first Commissioner to be confirmed was Dr. Kessler in 1990. Of the eight commissioners since his time, half were sworn in more than a year after their predecessor left the agency (Drs. Henney, McClellan, Crawford, and von Eschenbach). This is an institutional problem that should be addressed in the future.

Whether reporter or Alliance member, please keep sending your questions. If we don’t know the answer, we will find someone who does.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.