News Feature | February 26, 2016

Califf: FDA Workforce, Data Gathering, Patient Engagement Top Priorities

By Jof Enriquez,
Follow me on Twitter @jofenriq

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Newly-confirmed U.S. Food and Drug Administration (FDA) commissioner Dr. Robert M. Califf's top priority is strengthening the agency's workforce, including its ability to gather evidence from studies and patients to support regulatory decisions, which should be better communicated to the public.

The U.S. Senate voted 89-to-4 to confirm Califf as the next commissioner of the FDA, replacing Margaret Hamburg, who stepped down in March. Some senators had opposed Califf for his ties to pharmaceutical companies, which funded many of his research studies at Duke University. But his confirmation proved the majority thinks him the best person to lead an agency that faces mounting challenges.

In an interview with the Washington Post, Califf acknowledged the great talent pool at the FDA, individuals who make crucial decisions every day, "But the world is changing quickly, and the mandates for us to do things are growing. So we are really focused on recruiting and retaining talent. That sounds maybe unusual, but I really think for the future, having a strong workforce is our number one issue. A lot of the details will take care of themselves if we have the right people."

That includes having to deal with the exploding amount of data from many areas – such as from genomic medicine, social media, and electronic health records (EHRs) – that FDA needs to evaluate to come up with regulatory decisions.

"We really want to bolster the scientific infrastructure at FDA and take advantage of the opportunity that we have to have much better evidence," Califf told the Post.

EHRs, in particular, will be used by the agency as "early-warning systems" to track unsafe medical devices and drugs. Electronic data should help the federal agency generate “pretty good information about how a product is performing.” The idea is that the agency could more actively discern such problems, as opposed to more passively waiting for reports, Califf told the Wall Street Journal.

Califf says FDA will continue to push for the integration of unique device identifiers (UDIs) into EHRs and Medicare bills to better track adverse events involving devices in the post-market and real-world settings, where patient lives are at stake.

Seeking patients' input also will remain a top priority for the agency. Califf says FDA in recent years has begun to engage patients more closely in the decision-making process, but he vows to make it happen more quickly.

"As a doctor, I felt like I always had patients at the center of what I did," Califf told the Post. "The great thing I learned when I got to the FDA was how deeply the device and drugs and biologics groups already are [involved in patient outreach]. This is going to be a big focus. It’s not just taking into account patient advocacy groups. But now, with social media, we can go directly to people with diseases or problems and find out how they are doing, what they are thinking and what they need."

Communicating with the public should be a two-way process, and Califf says FDA will not only seek public feedback, but will need to better state its position about issues. In the interview with the Post, he says he feels 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."