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Nov 23, 2015
 |  BioCentury  |  Regulation

Califf's agenda

Califf's busy agenda as FDA commissioner would include clinical trial reform

Senate Democrats and Republicans last week drove a stake through allegations that Robert Califf's past interactions with pharmaceutical companies render him unsuitable to serve as commissioner of FDA. Strong bipartisan support from the Health, Education, Labor and Pensions Committee shifts the conversation from whether Califf will be confirmed to what he can accomplish in the fleeting time before the curtain falls on the Obama administration.

Theoretically, the next president could retain Califf, but realistically he can't count on spending much more than a year in the top job.

Democrat Hillary Clinton is the only presidential candidate who has expressed strong interest in FDA issues, and she is likely to want a commissioner who has close political ties to her inner circle.

She has also declared pharma companies her "enemy," so she would presumably appoint someone who hasn't had financial relationships with drug companies.

Her opponent, Sen. Bernie Sanders (I-Vt.), already has said he'll vote against Califf as commissioner because he wants someone in charge at White Oak who will use the job as a bat to beat down drug prices.

From the GOP side, any Republican who won the White House would be under pressure to demonstrate a sweeping break from President Obama's policies, and he or she would have a long list of supporters to reward with prestigious positions like FDA commissioner.

Two factors could compensate for Califf's short tenure. First, he has gotten a running start by serving since March as deputy commissioner for medical products and tobacco. Second, he has been thinking about what he could accomplish as commissioner for a long time.

Califf got as far as a White House interview in 2001 and was on a short list of candidates in 2008. When he left Duke University School of Medicine to take over the deputy commissioner's job, it was obvious he was a strong candidate to be nominated as a permanent replacement for Margaret Hamburg, who had recently resigned.

Assuming he clears the approval threshold, Califf's time would be divided among institutional priorities he must manage as well as goals he has been working on for decades that he could advance as commissioner.

At his Nov. 16 confirmation hearing and in informal remarks at a Friends of Cancer Research/Brookings Institution meeting last week, Califf provided a peek inside the second bucket.

He spoke passionately about transforming clinical trials through the integration of electronic health records, advancing patient engagement in medical product development, and advancing the science of biomarkers and surrogate endpoints.

Must-do's

Califf's "must-do" bucket is already filled past capacity with essential tasks and controversies that aren't related to medical products. These include completing the "deeming rule," which determines how FDA extends its authority to tobacco products, including electronic cigarettes, and implementing the Food Safety Modernization Act. Both are outside his area of expertise.

Califf...

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