President Barack Obama has nominated the Food and Drug Administration's Dr. Robert Califf, the current Deputy Commissioner for Medical Products and Tobacco, to lead the agency (see the White House announcement). Dr. Califf joined the FDA as deputy commissioner earlier this year after more than 30 years at Duke University and is a recognized global leader in cardiology and clinical research. His nomination to head the agency was expected after former commissioner Dr. Margaret Hamburg announced she would step down shortly after appointing Califf to Deputy Commissioner.
Stephen Ostroff, previously the FDA's chief scientist, has served as acting commissioner over the last six months.
In coming to FDA, Dr. Califf left his post as the director of the Duke Translational Medicine Institute (DTMI). He founded the Duke Clinical Research Institute (DCRI), the largest academic research organization in the world. Under his leadership, DCRI grew to 1,000 employees with an annual budget of $100 million, notes David Kroll of Forbes. Furthermore, Hamburg stated in her appointment of Califf back in Januaray that “Dr. Califf is recognized by the Institute for Scientific Information as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications.”
The reaction to Califf’s nomination has been positive.
“Robert Califf Could Transform The FDA – The Right Way” (Forbes): “Whoever winds up running the country after the next election would be wise to keep Califf at the FDA’s helm. He could handle either situation.”
"Califf Nomination for FDA Chief Gets Mostly High Marks--But ties with industry may be an issue" (MedPage Today). This article lists a wide range of health policy and cardiology experts who weighed in very positively on Califf’s nomination. For example, MedPage Today quotes Sanjay Kaul, MD, MPH, of Cedars-Sinai Heart Institute in Los Angeles, who wrote: "I can't think of a more qualified person than Dr. Califf to lead the FDA at the present time…He is an accomplished leader in cardiovascular disease research whose work has resulted in therapies that save lives and improve the quality of life for millions of patients."
In terms of how much change Califf would bring to the agency, the article quoted Steve Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic: "He's not going to sit on his hands…This is a guy who's going to make changes."
Importantly, Califf could be heading the agency at a significant time. The 21st Century Cures Act, recently passed by the House and awaiting Senate approval, outlines numerous changes seeking to streamline the drug approval process.
As the title of the Medpage Today article notes, some have been critical of Califf’s ties to industry, including Public Citizen and a Time article published in February entitled “Candidate to Lead FDA Has Close Ties to Big Pharma.” However Califf’s extensive experience clearly has had a positive impression on the Obama administration. Califf noted that collaboration between industry, academia, and government is vital. “The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” Califf says, as quoted in Time. 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 added it would be “useful to have someone [leading the FDA] who understands how companies operate because you’re interacting with them all the time.”
Further, Larry Husten of CardioBrief was critical of Public Citizen's call for the senate to reject Califf's nomination. "I think Public Citizen is mistaken, though it is certainly true that Califf has worked closely with industry throughout his career," Husten writes. "But if you’ve paid careful attention to his words it’s clear that Califf’s primary goal has never been to serve industry." He goes on to say that "I think [Califf] is interested in finding ways to use the enormous resources of industry to develop new therapies."