Few would dispute Robert Califf’s qualifications to be the next FDA commissioner, so the biggest question surrounding President Obama's decision to nominate him is 'Why wait until now?'

Check out our June interview with Robert Califf, Also see "Podcast: FDA's Califf Talks About Combo Product Reform, Commish Prospects" - Medtech Insight, 17 June, 2015..

The White House announced Califf’s nomination Sept. 15. If confirmed, he would succeed Margaret Hamburg, who left the position in April. Stephen Ostroff currently is serving as acting commissioner.

Califf’s nomination confirms much of the speculation that was swirling when he was named the deputy commissioner for medical products and tobacco in January.

Robert Califf

Source: Duke Photography

In his current agency role, Califf reports directly to Ostroff and manages cross-cutting clinical, scientific and regulatory initiatives for the drug, device, biologics and tobacco centers, as well as the Office of Special Medical Programs.

A world-renowned cardiologist and prominent researcher, Califf came to FDA from Duke University, where he was director of its Translational Medicine Institute and vice chancellor for Clinical and Translational Research.

He also had worked with FDA officials in several capacities Also see "FDA Lands Duke’s Califf As Top Deputy, Potential Next Commissioner" - Pink Sheet, 26 January, 2015..

Califf was thought to be a commissioner candidate because he was seen as acceptable to various stakeholders and has the ability to understand agency and outside positions.

In a tweet posted Tuesday afternoon, NIH Director Francis Collins called Califf a “superb physician scientist.”

The nomination will go through the Senate Health, Education, Labor and Pensions Committee before heading to the floor for full Senate approval.

Committee Chairman Lamar Alexander, R-Tenn., said in a statement, "Dr. Califf has impressive credentials. The committee will move promptly to consider his nomination. The FDA affects nearly every American and needs the certainty of a strong leader. I look forward to hearing from Dr. Califf specifically on how we can move medical discoveries more rapidly through the FDA and other agencies and get safe treatments and drugs into Americans' medicine cabinets."

It is unclear how long the nomination process will last or if it will ever be completed. Senate priorities and the upcoming presidential election may make it difficult for both parties to reach an agreement on even a non-controversial appointment.

An Intern Before Commissioner?

The timing of the White House nomination may cause some head-scratching, but there may be legitimate reasons for waiting several months after Califf joined the agency to make the move.

By allowing him time in the deputy commissioner position, Califf has been allowed what amounts to a seven-month internship in an FDA leadership role that ideally will prepare him to run the entire agency.

He also was allowed to get to know the key center and office directors and lay the groundwork for a smooth transition.

In addition, White House officials may have wanted to wait for Califf to break his industry ties before giving him the official nod.

Califf had to sever a number of consulting and other industry relationships that would create conflicts of interest in his work at FDA.

Even though he was working for the agency, for a few weeks Califf had to limit his interactions with companies and groups that he had worked with previously ([A#00150202007]).

Will Califf Survive The Election?

Although recent history may not support it, Califf may be in position to hold FDA’s top spot after the Obama administration departs in 2017.

With little time remaining in Obama’s term, White House officials were not expected to devote much energy toward pushing a nomination that if confirmed would not serve long in office.

But moving forward with the nomination suggests that Obama believes Califf carries enough favor among Democrats and Republicans that he could retain the position no matter which party controls the White House – assuming the next president doesn't prefer someone else for the post.

Even as the Califf nomination signals Administration willingness to devote political resources to FDA administration, also of note is that Ostroff apparently was passed over for the permanent position.

Ostroff also has not been with the agency long, but was chief scientist when he was named acting commissioner ([A#00150209018]).

Ostroff had said in the months since taking the position that he did not plan any major changes in agency direction, perhaps an indicator that he was not expecting to be in the job long-term.

He also did not rule out becoming the permanent commissioner, but said he wanted to remain at FDA no matter who has the job Also see "FDA Staying The Course Under Ostroff; Hamburg’s Concerns Will Remain Focus" - Pink Sheet, 21 April, 2015..

Focus Has Included Trial Reform, Biomarkers

Since joining the agency, Califf has focused on a few key issues, including clinical trial reform. Throughout his medical career, Califf has pushed streamlining the trial process to lower costs and improve efficiency.

In an August interview with “The Pink Sheet,” Califf said he wants to see a dramatic increase in the evidence that can be generated through clinical trials, as well as improve FDA understanding of biomarkers and surrogate endpoints.

Califf also said he wants to ensure that the knowledge of FDA’s long-serving staff is captured and available for future generations Also see "Oral History Of Drug Development: FDA’s Califf Wants Woodcock, Temple To Share Their Stories" - Pink Sheet, 10 August, 2015..

The philosophy would appear to fit with many of the policy initiatives included in the House 21^st Century Cures bill, one of two major legislative initiatives Califf likely would have to confront immediately upon confirmation ([A#14150710004]).

The other is the user fee reauthorization. Formal negotiations for several fee programs are expected to begin in the coming weeks Also see "PDUFA Budgeting: What Will Get Added, Subtracted – Or Multiplied By Cures?" - Pink Sheet, 2 September, 2015..

After the negotiations with industry, the user fee renewals require congressional approval, but that won't happen until 2017, so it is unclear what roll Califf would play in that final process, even as he is been tapped to wield more influence at the beginning of it.

Califf Nomination May Show Confidence In His Bipartisan Appeal

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