Feature Profile

Robert Califf: controversial new head of the FDA

BMJ 2016; 354 doi: http://dx.doi.org/10.1136/bmj.i3656 (Published 05 July 2016) Cite this as: BMJ 2016;354:i3656
  1. Jeanne Lenzer, associate editor, The BMJ
  1. jlenzer{at}bmj.com

The FDA’s new head has been accused of being too close to industry. Here, he tells Jeanne Lenzer why partnership with the private sector is vital

Robert Califf, the new commissioner of the US Food and Drug Administration, is on a mission: he wants to streamline medical research and to improve the methods used to evaluate drugs and devices in order to bring innovative products to market faster and more efficiently. However, his extensive ties to the drug and device industries are also proving controversial.

Califf cites several “critical issues” as priorities for the agency, including deaths from opioid overdose, bringing tobacco products under agency regulatory controls, food safety, antimicrobial resistance (including appropriate antimicrobial use on farms), interagency development of scientific standards, and precision medicine involving “genetic, genomic, biological, clinical, social, and environmental data” to improve health outcomes.1

Califf has enormous prestige and is widely respected. John Ioannidis, professor of medicine and of health research and policy at Stanford University School of Medicine, told The BMJ that Califf is a “sterling” choice as commissioner. Califf has more than 1200 publications in the peer reviewed literature, has been a member of multiple Institute of …

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