The Washington PostDemocracy Dies in Darkness

New FDA head Robert Califf vows to use ‘bully pulpit,’ better explain agency decisions

Robert Califf, a longtime Duke University cardiologist and researcher, was confirmed as the next leader of the Food and Drug Administration this week by a wide margin. The Senate voted 89 to 4 in favor of placing Califf in the agency's top post, where he replaces former FDA commissioner Margaret A. Hamburg.

The final tally on Wednesday, however, did not reflect the opposition Califf faced in the months after President Obama nominated him last September. While Califf received enthusiastic support from a array of health and patient advocacy groups, skeptics in the Senate and elsewhere cited his long-standing ties to the pharmaceutical industry -- which funded many clinical trials he oversaw as an academic -- and questioned whether his interests lay more with drug companies than with ordinary patients.

Aside from a confirmation hearing last fall, in which he defended his past work and said he had no intentions of lowering the FDA's standards for safety and effectiveness of drugs and devices, Califf largely remained silent. But after winning confirmation Wednesday, he spoke in a brief interview with the Post about his priorities as FDA commissioner, including a desire to better explain to the public how the agency operates. The following transcript has been edited lightly for length and clarity:

Washington Post: Congratulations on your confirmation. As FDA commissioner, I’m curious what your top priorities are going to be. There are obviously a long list of priorities. But what is at the top of that list?

Robert Califf: Well, at the very top of the list for me is the FDA workforce, because the FDA makes so many decisions every day. 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. 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.

My second priority is something that probably doesn’t surprise anyone who has followed my career. 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. 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.

WP: You encountered criticism during this process from senators who said you had too many ties to the pharmaceutical industry and to [drug] companies as a researcher. Tell me why people should not be concerned about that, and why they should trust that you’re going to be a fair and tough regulator.

Califf: In due diligence, the way it’s supposed to work, people should be concerned, and they should investigate and find out. But I think my record stood the test. You can see we had a bipartisan vote. There were some senators who were still unconvinced. But some of the toughest senators, like Sen. [Elizabeth] Warren, 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.

I think the best testament is that I went through an amazingly rigorous committee, hundreds of pages of written documentation, and then a full Senate review, and came out pretty well.

WP: There have been, as you know, efforts in recent years to more systematically consider patient perspectives, especially when it comes to new drugs. What role will patients have in the FDA that you run?

Califf: As a doctor, I felt like I always had patients at the center of what I did. But it was only about six or seven years ago that I got involved in the policies related to patient involvement. I’ve written some academic articles about this, and I’m very committed to it.

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. So, I would regard this as a central focus. But it’s not like I need to bring this to the FDA. It’s there. I just need to make it happen more quickly.

WP: Two other topics that have come up [during your nomination process]. One is the role that the FDA plays -- or some people argue doesn’t play -- when it comes both to the opioid crisis and to the issue of drug prices. I realize that the FDA doesn’t directly consider drug prices. But on those two issues, does the agency have work to do? Is it doing enough?

Califf: The opioid crisis has been at the forefront of all the discussions the last few days. What I’ve said to people is, the Congress has every reason to be concerned. The discussion is important, and it needs to be had. You’re also aware that we put out an extensive reorientation of the FDA’s approach [to opioids] in the New England Journal just a couple weeks ago. A big part of that is not only the actions we’re going to take, but also that we’ve got a lot to learn as we go along.

I don’t think anyone 10 years ago anticipated that these drugs would be associated with so much societal harm. 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.

This is going to take an effort by everyone involved. A fundamental issue here is over-prescribing of opioids. I think our [drug] labels are pretty clear and strong, but for reasons that are well known, doctors have gotten in the habit of prescribing more opioids than they should. That’s not an issue FDA can control, but we have a voice in it, and we’re going to work with other federal agencies to help that happen.

We’re also aware that there are 10 to 12 million Americans with severe, chronic pain that needs treatment. So, we’ve got to work with NIH and the industry to develop non-addictive, more effective treatments. And we have to work with [the Centers for Medicare & Medicaid Services] and payers to create practice environments where you can actually use non-opioid, behavioral treatments. It turns out, that’s complicated and it’s hard to do. I have a lot of experience before coming to FDA with trying to do it, so I feel like I have a good bully pulpit to talk from to say, ‘Yes, we’re going to step up to the plate at the FDA.’ But we also need everyone else to join us and step up to the plate.

What was your second question?

WP: Drug prices.

Califf: It’s clear that a wonderful drug that has a benefit, [but] which is not taken because a person can’t access it due to price or any other reason -- that actually is an FDA issue. By law we can’t consider price in our decision making. But there are a list of things we can do, and we are hard at work doing them -- generics being one. Eighty-eight percent of prescriptions are already generic. We have a prioritization of generics, so that when there is not an [existing] generic, [the first one] moves to the front of the line. We are also  in discussions with other HHS agencies about where our cooperation can help with their part of the pie. 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.

There’s a whole list of things like that we are working on, because we’d like the public to have access to the good treatments that are out there.

WP: You mentioned the bully pulpit that this job provides. I’m curious how you intend to use that, and in what ways the FDA itself needs to change?

Califf: First of all, I’d say the FDA is strong. 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.

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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