Published August 10, 2016
Nordic Cochrane Center, a Danish research and information center is challenging the European Medicines Agency’s (EMA) 2015 report on human...
— William Wilberforce
If confirmed by Congress, the next commissioner of the U.S. Food and Drug Administration (FDA) will be Robert M. Califf, MD. Dr. Califf is currently the FDA’s deputy commissioner for Medical Products and Tobacco—a position to which he was appointed on January 26, 2015,1 just two months prior to the end of former FDA commissioner Margaret Hamburg’s six-year term.2
Prior to joining the FDA in February of this year, Dr. Califf served as vice chancellor of clinical and translational research at Duke University in Durham, NC and as a member of the Institute of Medicine (IOM) Policy Committee and liaison to the Forum in Drug Discovery, Development, and Translation.1
While at Duke, he served as director of the Duke Translational Medicine Institute (DTMI) and professor of medicine in the Division of Cardiology at the Duke University Medical Center. Before that, Dr. Califf earned recognition as the founding director of the Duke Clinical Research Institute (DCRI), which is among the world’s largest academic research organizations, and he has been described as “one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications.”1
Additionally, Dr. Califf had served as a member of IOM committees that have recommended Medicare coverage of clinical trials and removal from the consumer market of dietary supplements containing the herbal product known as Ephedra. He has also been a member of the IOM’s Committee on Identifying and Preventing Medication Errors and the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology.1
By all accounts, Dr. Califf has stellar credentials to be the next FDA commissioner and replace Stephen Ostroff, MD, who has been serving as acting commissioner of the agency since April.3
However, there is another side to Dr. Califf’s background that suggests a conflict with the need for an independent, impartial head of the top federal agency tasked with legal authority for protecting the health of the American public through the effective regulation of food, drug and biological products. First, from 2006 through early 2015, Dr. Califf served as a board member and consultant for Faculty Connection, LLC of Durham, NC.4
In a recent article in MintPress News, reporter Carey Wedler writes that the “sole purpose” of Faculty Connection is to “help pharmaceutical companies evade and manipulate FDA regulations.”4 She adds, the company “brings together physicians and researchers from leading academic institutions with pharmaceutical, biotechnology and medical device clients.”4 During 2009-2015, Dr. Califf reportedly received about $215,000 in consulting fees from industry.5
In a 2014 conflict of interest disclosure,6 Califf acknowledged that part of his salary was underwritten by major pharmaceutical companies such as Merck, Bristol-Myers Squibb, Eli Lilly, and Novartis, and that he additionally received up to $100,000 in consulting fees from pharma.7
Even one of Dr. Califf’s top achievements, the founding of the $200 million DCRI which manages clinical trials on drugs around the world, was done so primarily with pharmaceutical industry funding.4 Approximately 63% of the center’s annual budget comes from industry, and 37% from government grants.5
Dr. Califf is recognized as an expert in conducting of clinical trials on pharmaceutical products, and it is precisely pharmaceutical companies that fund most of those trials, often in collaboration with federal health agencies or researchers at academic institutions who receive both industry and government research grants. The question, according to Aaron S. Kesselheim, MD of Brigham and Women’s Hospital in Boston, MA, is whether Dr. Califf would be able to “transcend those relationships as commissioner and advocate for a strong FDA.”5
Michael Carome, MD of the consumer advocacy group Public Citizen doesn’t think so. Here’s what he says…
[Califf] has amassed an extensive record of close collaboration with industry, through consulting fees, speaking fees and research grants supporting his salary. This will color his views when it comes to making regulatory decisions.5
Harvard political science professor Daniel Carpenter, who has written considerably about the FDA, is more direct about Dr. Califf’s ties with the pharmaceutical industry, and phrases it more succinctly… “In a sense, he’s the ultimate industry insider.”5
Dr. Califf appeared today before the U.S. Senate Health Committee for a confirmation hearing.8
1 U.S. Food and Drug Administration. Dr. Robert Califf named FDA Deputy Commissioner for Medical Products and Tobacco. FDA (press release) Jan. 26, 2015.
2 U.S. Food and Drug Administration. FDA Commissioner Margaret A. Hamburg Stepping Down. FDA Feb. 5, 2015.
3 Dennis B. FDA head Margaret Hamburg to resign in March; Ostroff to be acting chief. The Washington Post Feb. 5, 2015.
4 Wedler C. Obama’s New Appointee To Head The FDA Is A Big Pharma Mega-Lobbyist. MintPress News Oct. 19, 2015.
5 Tavernise S. F.D.A. Nominee Califf’s Ties to Drug Makers Worry Some. The New York Times Sept. 19, 2015.
6 DCRI Commercial Relationship Tracking Form (for Robert M. Califf, MD, MACC)
7 Calabresi M. Candidate to Lead FDA Has Close Ties to Big Pharma. TIME Feb. 19, 2015.
8 Ferris S, Sullivan P. Week ahead: ObamaCare repeal effort in trouble? The Hill Nov. 16, 2015.