Califf Nomination for FDA Chief Gets Mostly High Marks

Robert CaliffWASHINGTON — The nomination of Robert Califf, MD, as FDA commissioner is getting good reviews from most health policy and cardiology experts.

“He has a very good understanding of industry and academia, and think that will serve him well,” Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, told MedPage Today in a phone interview. “He built and grew the Duke Clinical Research Institute into a behemoth, so he has deep experience in drug development. On the medical products side, he has a deep and comprehensive understanding … from manufacturers and academia, so I think he’ll be very well suited there.” […]

Califf was nominated on Tuesday by President Obama; he is currently serving as FDA’s deputy commissioner for medical products and tobacco. Prior to that appointment, Califf was vice-chancellor for clinical and translational research at Duke University in Durham, N.C., where he also co-chaired the Clinical Trials Transformation Initiative, a public-private partnership co-founded by Duke and the FDA to identify and promote practices that will increase the quality and efficiency of clinical trials. […]

One area that might cause controversy with Califf’s nomination is his ties to the pharmaceutical industry. “His very close ties to industry [are] his greatest weakness from a public health point of view,” Diana Zuckerman, PhD, president of the National Center for Health Research, a think tank here that researches the safety of medical products for consumers, said in an email. “That’s why Republicans have supported his nomination and many Democrats have opposed it. Those ties have also been a source of great concern to public health experts across the country.”

“If he is confirmed, he will need to show his independence from industry in order to protect the safety of patients and the integrity of the FDA as a public health agency,” she said. “This will be especially important because the 21st Century Cures Act, which passed the House overwhelmingly and is being revamped in the Senate, has the strong support of pharmaceutical and device companies, as well as academic researchers who depend on industry funding, as Dr. Califf did when he was at Duke.”

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