Perspectives
As the new Deputy Commissioner for Medical Products and Tobacco at the US Food and Drug Administration (FDA), world-renowned cardiologist Robert Califf arrives at a time when the FDA’s overall responsibilities have grown exponentially as a result of five new major legislative mandates, more complex regulatory science, and an increase in health-care data, despite a tightening federal budget. Califf will oversee an annual budget of about US$2·3 billion and about half the agency’s 16 000 employees working at the FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Tobacco Products. In an interview with The Lancet before assuming his new post on March 2, Califf said his top priorities range from negotiating user fees with drug and medical device makers to working with Congress on legislation to speed up development of new drugs and treatments. The challenges that face the FDA seem to be the job’s main attraction for Califf. “You reach a point where you really enjoy complex things as opposed to simple things”, he said. “The mission of the FDA really is a complex balance.” The agency is responsible for regulating thousands of drugs and medical products, “where you really have to defend the health of the public against things which may be bad or dangerous”, he said. At the same time, he said, “part of the FDA’s mission for public health is to assure appropriate use and help companies understand how to develop products”. And then there’s another priority—what Califf called “the most fun part”—working to streamline clinical trials. “All sectors—Congress, both parties, FDA, NIH [National Institutes of Health], industry—everyone wants to be able to get answers through clinical trials more efficiently because they’ve gotten very bureaucratic and expensive.” Much of Califf’s career has been devoted to large international clinical studies, including trials on ezetimibe’s effects on cardiovascular disease, sitagliptin in patients with type 2 diabetes and a history of cardiovascular disease, and exenatide for type 2 diabetes. Before assuming his FDA position, Califf was the Director of the Duke Translational Medicine Institute at Duke University in Durham, NC, USA, a clinical research centre set up in 2006 to translate “ideas into innovations that improve health”, according to its website. Califf was also Duke’s Vice Chancellor for Clinical and Translational Research, and a Professor of Medicine in the Division of Cardiology at Duke University Medical Center. He said that due to his role at the FDA, he will step down from his clinical trials and resign from a host of other posts, including Editor-in-Chief of the American Heart Journal, Co-Chair of the Clinical Trials Transformation Initiative, and principal investigator for the coordinating center of the NIH Health Care Systems Research Collaboratory. www.thelancet.com Vol 385 February 28, 2015
Califf, aged 63 years, received his medical degree from Duke School of Medicine in 1978, and went on to complete an internal medicine residency at the University of California, San Francisco and a fellowship in cardiology at Duke. He is a Master of the American College of Cardiology and board-certified in internal medicine and cardiology. During his career, he has worked in every phase of research, from development to post-marketing surveillance, including the academic side of several large public–private partnerships with the FDA, and joint efforts between the FDA and NIH. When Mary Woolley, President of Research!America, heard of Califf’s appointment, she said her response was “jubilation”. The organisation’s roughly 400 members include research institutes, medical centres, scientific societies, patient groups, and companies. “His background and his commitment are very well-suited to the FDA”, she said. “He is an acknowledged leader in clinical research, he really knows the territory and he is committed to improving the clinical trial system, which is overdue for improvement.” “He is at the cutting edge of clinical trial design, translational research, and regulatory science”, said Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA, a coalition of nearly 200 patient and consumer groups, biomedical research advocates, health professional societies, and trade associations. “That makes him an asset to the agency.” FDA Commissioner Margaret Hamburg appointed Califf as Deputy Commissioner on Jan 26. Only a week later, she announced she will be leaving after 6 years, a move that fuelled speculation that Califf could succeed her, even though Stephen Ostroff, FDA’s Chief Scientist, was named Acting Commissioner. “Rob Califf has been under consideration to be the FDA Commissioner a number of times under both Democratic and Republican administrations”, said Peter Pitts, a former FDA Associate Commissioner and President of the Center for Medicine in the Public Interest. “And to date, he’s been the Ernie Banks of the FDA—a consistently high performing All-Star who never made it to the World Series.” Califf would make an “excellent” Commissioner because he is widely respected by FDA senior staff, is able to translate policy into action, and understands “FDA’s place in the health-care innovation ecosystem”, Pitts said. But Califf said the Deputy Commissioner position has some advantages. “It has an opportunity to do operational things and conceptual things at one level below, so I’m pretty happy if I can have room to operate as Deputy Commissioner.” Still, he’s not ruling out the prospect of a promotion. “As far as the Commissioner’s job goes, it’s not my call but of course I’d be interested if asked to do it.”
Duke Photography
Profile Robert Califf: leading cardiologist is new FDA Deputy Commissioner
See World Report page 759 For The Lancet podcast see http://www.thelancet.com/ lancet/audio
Susan Jaffe 765
As the new Deputy Commissioner for Medical Products and Tobacco at the US Food and Drug Administration (FDA), world-renowned cardiologist Robert Califf arrives at a time when the FDA’s overall responsibilities have grown exponentially as a result of five new major legislative mandates, more complex regulatory science, and an increase in health-care data, despite a tightening federal budget. Califf will oversee an annual budget of about US$2·3 billion and about half the agency’s 16 000 employees working at the FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Tobacco Products. In an interview with The Lancet before assuming his new post on March 2, Califf said his top priorities range from negotiating user fees with drug and medical device makers to working with Congress on legislation to speed up development of new drugs and treatments. The challenges that face the FDA seem to be the job’s main attraction for Califf. “You reach a point where you really enjoy complex things as opposed to simple things”, he said. “The mission of the FDA really is a complex balance.” The agency is responsible for regulating thousands of drugs and medical products, “where you really have to defend the health of the public against things which may be bad or dangerous”, he said. At the same time, he said, “part of the FDA’s mission for public health is to assure appropriate use and help companies understand how to develop products”. And then there’s another priority—what Califf called “the most fun part”—working to streamline clinical trials. “All sectors—Congress, both parties, FDA, NIH [National Institutes of Health], industry—everyone wants to be able to get answers through clinical trials more efficiently because they’ve gotten very bureaucratic and expensive.” Much of Califf’s career has been devoted to large international clinical studies, including trials on ezetimibe’s effects on cardiovascular disease, sitagliptin in patients with type 2 diabetes and a history of cardiovascular disease, and exenatide for type 2 diabetes. Before assuming his FDA position, Califf was the Director of the Duke Translational Medicine Institute at Duke University in Durham, NC, USA, a clinical research centre set up in 2006 to translate “ideas into innovations that improve health”, according to its website. Califf was also Duke’s Vice Chancellor for Clinical and Translational Research, and a Professor of Medicine in the Division of Cardiology at Duke University Medical Center. He said that due to his role at the FDA, he will step down from his clinical trials and resign from a host of other posts, including Editor-in-Chief of the American Heart Journal, Co-Chair of the Clinical Trials Transformation Initiative, and principal investigator for the coordinating center of the NIH Health Care Systems Research Collaboratory. www.thelancet.com Vol 385 February 28, 2015
Califf, aged 63 years, received his medical degree from Duke School of Medicine in 1978, and went on to complete an internal medicine residency at the University of California, San Francisco and a fellowship in cardiology at Duke. He is a Master of the American College of Cardiology and board-certified in internal medicine and cardiology. During his career, he has worked in every phase of research, from development to post-marketing surveillance, including the academic side of several large public–private partnerships with the FDA, and joint efforts between the FDA and NIH. When Mary Woolley, President of Research!America, heard of Califf’s appointment, she said her response was “jubilation”. The organisation’s roughly 400 members include research institutes, medical centres, scientific societies, patient groups, and companies. “His background and his commitment are very well-suited to the FDA”, she said. “He is an acknowledged leader in clinical research, he really knows the territory and he is committed to improving the clinical trial system, which is overdue for improvement.” “He is at the cutting edge of clinical trial design, translational research, and regulatory science”, said Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA, a coalition of nearly 200 patient and consumer groups, biomedical research advocates, health professional societies, and trade associations. “That makes him an asset to the agency.” FDA Commissioner Margaret Hamburg appointed Califf as Deputy Commissioner on Jan 26. Only a week later, she announced she will be leaving after 6 years, a move that fuelled speculation that Califf could succeed her, even though Stephen Ostroff, FDA’s Chief Scientist, was named Acting Commissioner. “Rob Califf has been under consideration to be the FDA Commissioner a number of times under both Democratic and Republican administrations”, said Peter Pitts, a former FDA Associate Commissioner and President of the Center for Medicine in the Public Interest. “And to date, he’s been the Ernie Banks of the FDA—a consistently high performing All-Star who never made it to the World Series.” Califf would make an “excellent” Commissioner because he is widely respected by FDA senior staff, is able to translate policy into action, and understands “FDA’s place in the health-care innovation ecosystem”, Pitts said. But Califf said the Deputy Commissioner position has some advantages. “It has an opportunity to do operational things and conceptual things at one level below, so I’m pretty happy if I can have room to operate as Deputy Commissioner.” Still, he’s not ruling out the prospect of a promotion. “As far as the Commissioner’s job goes, it’s not my call but of course I’d be interested if asked to do it.”
Duke Photography
Profile Robert Califf: leading cardiologist is new FDA Deputy Commissioner
See World Report page 759 For The Lancet podcast see http://www.thelancet.com/ lancet/audio
Susan Jaffe 765
