Clinical Research Expert Califf Nominated to Head FDA

President Obama’s nomination of Robert Califf to lead the FDA is drawing praise from those in industry and academia who see him as an outstanding choice and a strong leader deeply respected by the scientific community.

“When asked who was on my short list of potential commissioners, I said ‘Robert Califf is the short list,’” Peter Pitts, president and founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner, told CTA.

The Biotechnology Industry Organization finds Obama’s choice encouraging, saying the cardiologist and clinical trial expert has a firm understanding of the challenges and opportunities of 21st Century medicine.

President Obama announced the nomination on Sept. 15, capping a swift rise for the respected clinical researcher, who assumed the agency’s number two role — deputy commissioner for tobacco and medical products — in March.

His nomination is subject to Senate confirmation.

If confirmed, he would take over for interim commissioner and former FDA Chief Scientist Stephen Ostroff.  Margaret Hamburg held the position for six years before resigning in March. At the time of her departure, it was widely speculated that Califf would be the logical choice to assume the top spot.

As deputy commissioner, Califf has provided executive leadership for CDER and CBER and helped advise the interim commissioner on priorities and policy setting for pharmaceutical oversight. 

Before joining the agency, he was a professor of medicine and vice chancellor for clinical research at Duke University, where he worked for 33 years.

A 1978 graduate of Duke’s medical school, Califf was a founding director of the Duke Clinical Research Institute — the world’s largest academic research organization. He was principle investigator for the NIH Health Care Systems Research Collaboratory and a co-director of the National Patient-Centered Clinical Research Network.

Not everyone welcomed Califf’s nomination. Michael Carome, director of Public Citizen’s Health Research Group, called for the senate to reject his nomination, citing Califf’s long history of financial ties to drugmakers. Carome said his appointment would accelerate a decades-long trend where the agency makes decisions more aligned with industry than with public health and patients.

In particular, Carome expressed the need for clinical trial reform, saying there is too much drift toward making trials faster and easier.

But most disagreed with Public Citizen’s assessment.

Margaret Anderson, executive director of FasterCures and past president of Alliance for a Stronger FDA, told CTA that early in his tenure as deputy commissioner at the FDA, Califf spoke out about the science of patient input and related methodologies in clinical trials, a key focus of the 21st Century Cures Act.

Robert Harrington, chairman of the Department of Medicine at Stanford University, who worked with Califf at Duke University for more than a decade, said the nominee understands both the appropriateness of industry-academic collaborations and the necessary boundaries. By necessity, Califf has collaborated with research funders, including private industry, to plan and implement clinical trials, he said.

Pitts says Califf’s experience working with the FDA from the inside as deputy commissioner coupled with his past dealings have earned the respect of senior staff within the agency. That respect will go a long way, as his success will be largely based on his ability to work with senior leadership. — Kellen Owings

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