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FDA Confirmation for Califf?


Pharmaceutical Executive

September 17, 2015.

This week, the White House nominated Robert Califf to head FDA, long after he came to the agency in January 2015 as deputy commissioner for medical products and tobacco. A prominent cardiologist at Duke University with an extensive involvement in efforts to modernize drug development and the clinical research system, Califf has been on everyone’s short list to head the agency and was expected to replace commissioner Margaret Hamburg when she resigned in March 2015. Instead, FDA chief scientist Stephen Ostroff was appointed to hold the fort as acting commissioner, raising speculation as to whether Califf would ever move up.

But if President Obama wants his legacy to include progress on implementing personalized medicine, Califf should provide strong support. He has long advocated for a “learning healthcare system” able to provide real-time data to foster more efficient and effective biomedical discovery and product development. He has been a leading participant in Institute of Medicine initiatives on preventing medical errors and modernizing research and drug discovery and translation and has served on numerous FDA advisory committees. Friends of Cancer Research chair Ellen Sigal praised Califf’s “diverse background” and said that his knowledge of clinical and translational medicine will enable him to improve the drug approval process “while ensuring that patients are receiving the safest and most effective treatments as quickly as possible.”

His extensive experience running clinical trials for major pharma companies, though, has raised questions about conflicts of interest. When he came to FDA, he had to divest holdings in two biotech companies and end consulting relationships with several leading firms. Moreover, Califf lacks the public health experience that was a hallmark of Hamburg’s tenure. A question is whether Califf’s “cleansing” process over the past nine months and experience in developing critical therapies for patients now makes him sufficiently independent to serve as FDA commissioner.

Califf’s first public remarks after coming to FDA occurred at a public meeting on pediatric research in March 2015, a move reflecting his strong interest in supporting research on critical therapies for neonates and children with severe diseases. He mentioned how globalization and the need for standards and new biomarkers are critical issues for FDA. And he reiterated his interest in finding ways to make clinical trials more informative and less wasteful.

At the June 2015 annual meeting of the Drug Information Association, Califf discussed the challenges and promise of precision medicine, noting the need to better understand how individuals respond differently to treatment. He cited the importance of developing computing and informatics able to handle huge amounts of data from electronic health records. Improving the clinical trial system, he said, would enable studies to answer more questions at lower cost.

However, time is short to obtain Senate approval of his nomination, especially with a packed Congressional schedule this fall, including a stiff battle over funding the federal government for the coming year. Even though Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, said his panel would “move promptly” to consider Califf’s nomination, his committee also is working on legislation to overhaul FDA research and regulatory policies, its version of the the 21st Century Cures legislation approved several months ago by the House.

FDA will need a strong leader as it moves forward with the intense process of renegotiating user fees for drugs and medical products, which are crucial to maintaining an efficient FDA approval process. In addition, FDA recently proposed a major overhaul of its program for ensuring food safety and is under pressure to devise controls for the rapidly expanding e-cigarette market. The Senate HELP Committee is concerned about delays in approving more biosimilars, and FDA governance of diagnostic tests, regulation of drug marketing and communications, and FDA efforts to curb opioid abuse all demand the Commissioner’s attention. Just how fast and effectively FDA approves new drugs for market, moreover, remains a critical issue for all parties.

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