Robert Califf, M.D., President Barack Obama’s nominee to be the next FDA commissioner and seen by some as a clinical research insider, is being called “a terrific choice” who is “very open to new ideas” by experts in the clinical trials sector.
Califf has been the agency’s deputy commissioner for medical products and tobacco—effectively the No. 2 post—since Margaret Hamburg resigned in March. The president nominated him to the top post last week.
A prominent cardiologist and medical researcher, as well as vice chancellor for clinical and translational research at Duke University, Califf was considered a likely candidate for the top FDA job since he became deputy commissioner. He is widely known for leading scores of pivotal clinical trials and is also seen as the nation’s most cited medical author in academia, with more than 1,200 journal articles.
In addition, he was the founding director of the Duke Clinical Research Institute, considered the world’s largest academic research organization. He also served as director of the Duke Translational Medicine Institute and became a national leader in the growing field of translational research, which is a key to ensuring that advances in science translate into medical care.
Deeply versed in FDA issues, particularly the clinical testing of drugs and devices, he also has served on expert committees that advise the FDA. Beyond his academic experience, Califf has worked closely with the pharmaceutical industry and encouraged greater cooperation among patient groups, governments and the biopharmaceutical sector.
“He is very open to new ideas and seems to be able to handle conflicting tensions, but he faces some major challenges in trying to reform clinical research with its very redundant and expensive regulatory structure in the clinical trial process,” said Cami Gearhart, CEO of Quorum Review IRB. “Bob understands clinical trials, big data and the importance of respecting the individuals who participate as trial subjects. From my perspective, what he will be doing soon is shepherding the 21st Century Act through the Senate and bringing the FDA into alignment with other agencies on the Common Rule.”
Both pieces of legislation are controversial. The 21st Century Cures Act would require the FDA to consider more flexible forms of clinical trials and incorporate patient experiences into its review process; the Senate is considering a similar bill. The Common Rule, which took effect in 1981, governs institutional review boards (IRBs) for oversight of human research.
As FDA deputy commissioner, Califf provided executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products. He is known for making data-driven decisions.
“He’s widely respected by the medical community and represents a terrific choice to lead the FDA,” Steven Nissen, M.D., head of cardiovascular medicine at the Cleveland Clinic, told Reuters. “He has good ideas but he doesn’t run over people with them. He will get along well with Congress.”
Califf’s experience working on vital issues with numerous groups that directly impact patients’ lives has drawn praise from many organizations, such as Friends of Cancer Research.
“He will bring a truly important and unique perspective,” Ellen Sigal, chair of the nonprofit group, said in a prepared statement. “This is a very important choice at this time to carry out the mission of an agency that keeps the country safe and gets new therapies to those that need them most.”
Califf also is a staunch supporter of the collaboration among regulators, the government and the biopharmaceutical industry, saying it is a necessary, albeit sometimes uncomfortable, part of modern drug development. Earlier this year, he told Time magazine that the FDA’s role includes both regulating an industry and creating conditions where the industry can thrive.”
“The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” he told Time, adding there is “a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive—and the FDA’s got to do both.”
Califf’s nomination by the White House, made in a statement naming other officials for various federal positions, still requires confirmation by the Senate although some industry observers do not expect him to face any major opposition. He also is no stranger for the FDA top job, which Hamburg had for six years: She and Califf were both considered by Obama, who selected Hamburg over him, according to FDA officials. In April, Stephen Ostroff, the FDA’s chief scientist, became the agency’s acting commissioner.
“I hope that Congress will respond quickly [to Califf’s nomination],” said Francis Collins, director of the National Institutes of Health, who called it “a fantastic nomination … he has such a wealth of experience in how to do research.”
Still, Califf’s experience at Duke and former ties with the pharmaceutical industry have raised some concerns by the National Center for Health Research, a Washington-based group focusing on medical product safety.
“Dr. Califf’s expertise and his close ties to the pharmaceutical industry are both well-known,” Diana Zuckerman, president of the nonprofit National Center for Health Research, told The Wall Street Journal. “His ties to the industry have been a source of great concern to public health experts when he was previously considered for FDA commissioner, and those ties raise important questions about this nomination.”
One nonprofit group that praises Califf as the FDA’s top leader is the National Organization for Rare Diseases (NORD). He spoke at the organization’s major conference in 2012.
“He has demonstrated knowledge for the challenges in developing orphan drugs and his support for the rare disease community” said NORD President and CEO Peter Saltonstall. “We welcome his nomination as the next FDA commissioner and look forward to working with him in his new capacity.”
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This article was reprinted from Volume 19, Issue 37, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »