Incoming FDA chief Califf outlines priorities

Incoming FDA commissioner Dr. Robert Califf, confirmed yesterday by the U.S. Senate, said he plans to make recruiting and retaining talent his 1st priority.

“That sounds maybe unusual, but I really think for the future, having a strong workforce is our number 1 issue. A lot of the details will take care of themselves if we have the right people,” Califf told the Washington Post yesterday. “We have a great talent pool at the FDA. But the world is changing quickly, and the mandates for us to do things are growing.”

The 2nd priority will be to enhance the federal safety watchdog’s ability to gather good evidence, he told the newspaper.

“This is an unprecedented time of evidence generation, ranging from genomic medicine to use of social media to the astonishing opportunity with electronic health records. We really want to bolster the scientific infrastructure at FDA and take advantage of the opportunity that we have to have much better evidence,” said Califf, who joined the FDA in January 2015. “My experience in the year I’ve been there is that we do really well at FDA when we have good evidence. And when we don’t have good evidence, it’s a matter of opinion and politics, and it often doesn’t go as well because no one knows the right answer.”

His appointment was met with praise by the medical device, biotech and pharma industries.

“MDMA congratulates Dr. Califf on his approval as the next FDA commissioner, and we look forward to working with him to ensure America’s patients and providers are the first to benefit from American medical technologies,” Medical Device Manufacturers Assn. president & CEO Mark Leahey said in prepared remarks. “Innovators across the United States continue to address some of our nation’s most pressing health care challenges, and Dr. Califf’s leadership will play a prominent role in determining how successful they will be in developing safe and effective therapies and cures for the 21st century. It is critical that we have predictable and reasonable regulatory pathways for medical technologies, and MDMA will continue to work with the broad collection of stakeholders who are committed to these important goals.”

“We are pleased that today’s Senate vote confirming Dr. Califf as the new FDA commissioner will provide permanent leadership to this vital agency that does so much to protect and promote the public health. We look forward to working with the new commissioner to ensure that American patients have timely access to the life-saving and life-enhancing innovations our industry provides,” added Janet Trunzo, technology & regulatory affairs executive VP at AdvaMed.

“BIO extends our congratulations to Dr. Califf on his confirmation as commissioner of the FDA, a job that carries tremendous responsibility in protecting public health and advancing biotechnology innovation. Dr. Califf’s confirmation comes at a time of tremendous advances being made in biotechnology and regulatory science, and I am confident that he will provide the stability, leadership and confidence the public seeks from an agency entrusted with such a critical mission,” Biotechnology Innovation Organization president & CEO Jim Greenwood said in a prepared statement.

Ex-AdvaMed CEO Steve Ubl, now in the same role at PhRMA, said the commissioner role “is critical to the agency’s continued ability to fulfill its public health mission and to bring new cures and innovative therapies to patients in need.”

In his interview with the Post, Califf disputed the criticism from presidential candidate Sen. Bernie Sanders (I-Vt.) and other senators that he’s to close to the pharmaceutical industry to be objective.

“There were some senators who were still unconvinced. But some of the toughest senators, like Sen. [Elizabeth] Warren (D-Mass.), for example, [voted for me]. It’s in the public record what I had to do, which is go back to every clinical trial I’d ever done and produce a record of it and prove it was published. She ended up saying, ‘Hey, this guy did it as well as it could be done.’ So I think my record shows that I’m for medical products that work and are effective. When they’re not, I’ve been outspoken,” he said.

The FDA can do a better job of explaining its decisions and policies, Califf added.

But I also feel like the FDA can do a better job of explaining its decisions and policies on all fronts, including the public. It’s not that there’s not a good effort already, but we can do better.

For me, my career has been developing and evaluating therapies. I think I’m in a great position to help motivate the collaboration that’s needed across society to have a system where we have much better information, and where it’s explained in a way that people can make better decisions. I intend to take every opportunity to that — even in audiences that may have concerns about specific decisions the FDA makes — so we can get out there and hear what they have to stay, and also they make sure they understand why we’re doing what we’re doing.

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