Robert Califf, M.D., a cardiologist, and the number two person at the FDA since March has been nominated by the White House to become the new head of the agency.
His thoughts about the agency’s mission to “protect” and “promote” public health will be scrutinized by industry and consumer groups as Congress decides whether or not to confirm his nomination. The Congress and the President aren’t getting along so well, so confirmation of this self-proclaimed Democrat is not a given.
Califf comes from industry, not the public health sector like his predecessor, Margaret Hamburg, M.D. Will he lean towards the “promotion” or “protection” of public health?
The New York Times reports that Califf has deeper roots to industry than any FDA commissioner in recent memory. Some public health advocates worry about the direction he will take the agency. Under Hamburg, the agency earned kudos from AdvaMed by reducing the time needed to push devices through the agency’s regulatory system.
According to the Times, he has written scientific papers with industry researchers, and his financial disclosure form in 2014 listed seven drug companies and a device maker that paid him for consulting and six others that partly supported his university salary. A conflict-of-interest section at the end of an article he wrote in the European Heart Journal last year declared financial support from more than 20 companies.
He also founded and ran the Duke Clinical Research Institute, a $200 million center that manages clinical trials in more than 65 countries involving more than 1.2 million patients. Supporters say that management experience should serve him well at the helm of the drug agency, which oversees everything from prescription drugs and pacemakers to peanut butter and pet food.
A Department of Health and Human Services (DHS) spokesperson reportedly said that Califf had been through “a comprehensive screening process for conflicts of interest, ” and that officials had “put in place measures to ensure that he is appropriately recused from matters that would give rise to conflicts, ” including the new cholesterol medicines.
In 2014, Califf presented a slide show titled “Disrupting Clinical Research: Transforming a System.” It said the drug and device development system was in crisis, and included a downward-sloping chart that illustrated the number of drugs approved per billion dollars spent on research over time.
“Regulation provides barrier to disruptive innovation, ” said the second-to-last slide, called “Disruptive Innovation in Health Care.”
The DHS spokesman said Califf was using the slide as a means of “identifying the challenge and the tension inherent in the FDA’s charge” between encouraging innovation and protecting the public’s health. He said the slide was not a suggestion to deregulate.
In an interview with Time Magazine earlier this year, Califf said collaborations between academic researchers, the government and the pharmaceutical industry are a necessary, if sometimes uncomfortable, reality of modern drug development.
“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 that 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.”
No hearings have been scheduled to consider his nomination.
