NEJM Endorses Robert Califf for FDA Commissioner

Citing experience, leadership, and dedication to improving patient outcomes, the New England Journal of Medicine has come out in support of President Obama’s nomination of Robert M. Califf, MD, a prominent cardiologist and researcher, to head the US Food and Drug Administration. 

In an editorial published online October 28, 2015, the journal’s long-time Editor-in-Chief Jeffrey M. Drazen, urged the Senate to “act favorably” on Califf’s nomination.

Obama nominated Califf last month to replace Margaret A. Hamburg, who stepped down in March after 6 years.

“We think his confirmation as commissioner should proceed as quickly as possible,” Drazen writes. “Because the FDA oversees the safety and, in some spheres, the efficacy of products that constitute about 25% of our economy, the country needs a strong and experienced leader who can keep the FDA focused on its mission.”

Califf has faced some criticism from some who say he is too closely tied to industry. Senator and presidential candidate Bernie Sanders has spoken out against Califf, saying he does not believe he will “stand up to the pharmaceutical companies and work to substantially lower drug prices.”

But according to Drazen, Califf’s record speaks for itself. Since 2005, he writes, Califf “has reported, as an investigator, the outcomes of 7 clinical trials sponsored solely by industry in primary publications in major general medical journals. Of these trials, 4 had a negative outcome (ie, not favoring the intervention), 2 favored the intervention, and one, with a factorial design, had a mixed outcome. Given this performance, it is impossible to argue that Califf has a pro-industry bias.”

Additionally, Drazen says the majority of Califf’s funded salary over the last 3 years has come not from pharmaceutical companies but from grants and research-oriented organizations including the NIH Collaboratory, the Patient-Centered Outcomes Research Network, and the Duke Center for Medicare and Medicaid Innovation project.

In recent years, Califf has co-authored studies on statins, novel oral anticoagulants for A-fib, provisional eptifibatide, and cardiovascular complications related to diabetes drugs.

Sources: 
1. Drazen JM. Califf for the FDA. N Engl J Med. 2015;Epub ahead of print.
2. Kroll D. Bernie Sanders opposes Califf nomination to lead FDA, cites pharma industry ties. Forbes. Published: October 9, 2015. http://www.forbes.com/sites/davidkroll/2015/10/09/bernie-sanders-opposes-califf-nomination-to-lead-fda-cites-industry-ties/. Accessed: October 29, 2015. 

Disclosures:

• Drazen reports that he is employed by the New England Journal of Medicine as Editor-in-Chief. 

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