As FDA commissioner, Califf plans on focusing on evidence-based medicine

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When Robert M. Califf, MD, takes over as FDA commissioner, the prominent cardiologist plans on focusing on evidence-based medicine and recruiting and retaining talent at the agency.

Califf spoke with the Washington Post in a brief interview soon after the Senate confirmed his appointment on Feb. 24. The Senate voted 89-4 in favor of Califf, who joined the FDA last year as deputy commissioner of medical products and tobacco.

President Barack Obama nominated Califf as commissioner on Sept. 15, 2015. He replaces Margaret Hamburg, MD, who stepped down as FDA commissioner last March. Stephen Ostroff, MD, was the FDA’s acting commissioner until the Senate confirmed Califf.

“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 Washington Post. “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.”

Califf also addressed concerns that Senator Edward Markey (D-Mass.) voiced about prescription opioids. Markey asked for reforms to the FDA approval process for opioid painkillers, which have been linked to overdoses, addiction and death.

On Feb. 4, Califf, Ostroff and Janet Woodcock, MD, wrote an article in the New England Journal of Medicine acknowledging the “unfolding public health crisis” of opioid abuse, addiction and overdose. They vowed to work on the issue while also making sure the medications are available to patients who need them.

“I don’t think anyone 10 years ago anticipated that these drugs would be associated with so much societal harm,” Califf said in the interview with the Washington Post. “So, how to take into account societal risks when you look at the risk-benefit of a drug—that’s complicated. We’re contracting with the Institute of Medicine to get a broad, societal perspective on that. As we go through all the things we outlined in our plan, we’ll keep revising what we are doing to get it right.”

As for the increasing costs of medications, Califf told the Washington Post that the FDA does not control prices and cannot make approval decisions based on costs. However, he said that 88 percent of medications are generics and added that the FDA would work with the Department of Health and Human Services and other agencies

“We can’t directly change things [on costs], but by providing good information about risk and benefit and better data, those who are making coverage decisions can make better decisions,” he said.

Califf said he would emphasize public outreach in his new role and keep everyone informed of what’s going on at the agency.

“First of all, I’d say the FDA is strong,” Califf told the Washington Post. “That’s clear when you walk around and see the hundreds of decisions being made in a way that people don’t even think about because it’s regarded as routine. 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.”