The New England Journal of Medicine is endorsing Dr. Robert Califf, the White House's nominee, as the next head of the U.S. Food and Drug Administration.
Califf, who has served as the FDA deputy commissioner for Medical Products and Tobacco since January, was described in a NEJM editorial published this week as “a strong and experienced leader."
President Barack Obama nominated Califf in September to replace Dr. Margaret Hamburg, who stepped down in February. Since then, Califf has faced unflattering news reports that have raised questions about his ties to the pharmaceutical industry.
NEJM Editor-in-Chief Dr. Jeffrey Drazen contended that Califf's track record as a researcher made concerns about his possible associations with drug and medical-device makers specious.
Drazen argued Califf has investigated seven industry-sponsored clinical trials, and negative outcomes were found in four of them.
“Given this performance, it is impossible to argue that Califf has a pro-industry bias,” Drazen wrote.
Democratic presidential candidate Sen. Bernie Sanders (I-Vt.), earlier this month said he planned to vote against Califf's confirmation. Sanders said he made his decision after The New York Times reported that while Califf served as director of the Duke Clinical Research Institute, the center received a majority of its funding from drug and medical-device companies.
In the past month, reports have surfaced that reveal part of Califf's salary at Duke was underwritten by drug companies, including Merck & Co., Bristol-Meyers Squibb, Eli Lilly and Company and Novartis, and that he collected consulting fees in 2014 from Bayer HealthCare and Amgen, according to a financial disclosure form.
“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices,” Sanders said. “Unfortunately, I have come to the conclusion that Dr. Califf is not that person.”
Addressing Califf's pay, Drazen wrote that the majority of Califf's salary for the last three years has come from a variety of organizations including the NIH Collaboratory, the Patient-Centered Outcomes Research Institute and Duke University's Center for Medicare and Medicaid Innovation project.
“Califf's experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpassed qualifications for the post of commissioner of the FDA,” Drazen wrote. “We strongly endorse his nomination and urge the Senate to act favorably on it.”
A date for Califf's confirmation hearing has not yet been set but is expected to take place in November.
