Robert Califf, M.D., vice chancellor of clinical and translational research at Duke University, not only was named the FDA’s new deputy commissioner for medical products and tobacco. He’s also now a potential candidate for the top FDA post, following FDA Commissioner Margaret Hamburg’s announcement late last week that she will be stepping down.
While the FDA named Stephen Ostroff, its chief scientist, as acting commissioner, rumors are swirling that Califf, who is widely known among the FDA’s leadership, of the FDA, could be a lead contender to become FDA commissioner. Hamburg is stepping down in March after nearly six years leading the FDA, the longest tenure in the modern era.
Califf, 63, who spent most of last week in Washington, D.C., preparing for his new position, also is director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute, one of the largest academic CROs with more than 200 faculty and 1,000 staff. Califf, a cardiologist who earned both his undergraduate and medical degrees at Duke, has been on the university’s faculty for the last 31 years.
“Dr. Califf’s deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve upon, the significant advances we’ve made in medical product development and regulation over the last few years,” Hamburg said in a press release announcing his appointment.
While Ostroff will fill Hamburg’s position until a new commissioner is named, Califf’s colleagues and friends view him as a viable candidate to lead the FDA.
“He could very easily be FDA commissioner under any administration and easily get through the confirmation process,” said Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest. “For many years, Dr. Califf has been involved in many of the issues that impact the FDA as an outsider observer. He is part of the circle of people that speaks to the FDA, which helps him understand what is happening from a non-staff position. He also has been an outside adviser. Over the years, his name has come up on the short lists from Democrats and Republicans as a possible FDA commissioner.”
The deputy position, which has been unfilled for nearly two years, provides executive leadership to the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH) and the Center for Tobacco Products. In addition, he will oversee the Office of Special Medical programs in the Office of the Commissioner.
The agency said he will “manage crosscutting clinical, scientific and regulatory initiatives in several key areas,” including personalized medicine and the advisory committee system.
During a recent telephone press conference announcing his appointment, Califf told reporters one of his top priorities will be to find ways to streamline the clinical trials process. He also will focus on the 21st Century Cures initiative being promoted in Congress to speed new therapies to market.
“Frankly, if anyone can make a difference at the FDA, given the challenges, complexities and political realities, it is Rob Califf,” said Robert Harrington, M.D., chairman of the department of medicine at the Stanford University School of Medicine, who has known Califf for 25 years. “He has an extraordinary high intellect and understands the theoretical and practical issues and command of quantitative science, along with knowledge of clinical research. He also has an interpersonal skill set that is second to none.”
The prolific cardiologist is widely known in medical academic circles as the author or co-author of more than 1,100 peer-reviewed articles, reviews and editorials, making him one of the 10 most frequently cited authors in the field of medicine, according to The Institute for Scientific Information.
Califf also is editor-in-chief of The American Heart Journal and has served on the FDA’s Cardiorenal Advisory Panel and on the Pharmaceutical Roundtable of the Institute of Medicine. He was part of its Committee on Identifying and Preventing Medication Errors, and served on committees that recommended Medicare coverage for clinical trials and the removal of ephedra (an herb used in medicines as a dietary supplement for weight loss and obesity that had serious side effects, officially banned by the FDA in 2006).
Eric D. Peterson, M.D., executive director of the Duke Clinical Research Institute and professor of medicine, a long-time colleague, calls Califf a visionary, an internationally respected investigator and a leader who can pull together disparate opinions to drive a compromise agreement, an ability he said will benefit the Office of Medical Products and Tobacco.
“I think Dr. Hamburg chose Rob because she would like to see some initiatives that start at the top of the FDA and move down the organization,” said Peterson, who has known Califf for more than 20 years. “The FDA faces many important decisions, and Rob is the right person to lead that organization. He knows how to develop more evidence on a streamlined basis to get innovative results quicker and at a lower cost. Those are regulation areas that Rob has thought about.”
Califf also is an inveterate blogger, which Pitts said could continue at the FDA, as he can explain in layman’s terms to researchers and to Congress what goes on at the FDA. Califf launched a blog 13 months ago predicting that 2014 would be the tipping point for a series of widespread changes in clinical research in the coming years.
“A major shift to a new data fabric of electronic health records, registries and data derived directly from people/patients from personal devices will begin to supplant traditional standalone data systems,” Califf wrote. “The change will trigger a reformation of clinical epidemiology and physiology as we apply big data methods to reclassify disease and understand biology, and it will be applied to populations.”
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