Dr. Robert Califf became commissioner of the Food and Drug Administration in February, a year after joining the agency as head of medical products and tobacco regulation. The 64-year-old cardiologist brings to the job more than three decades of experience in clinical trial research at Duke University Medical Center. Modern Healthcare reporter Steven Ross Johnson began by asking Califf about some of the controversies that swirled around his nomination. This is an edited transcript. (Califf leads our ranking of the 50 Most Influential Physician Executives and Leaders for 2016.)
Modern Healthcare: While your confirmation received bipartisan support, several Democratic lawmakers said the FDA hasn't done enough on opioid abuse.
Dr. Robert Califf: They should be concerned and even upset because this is a massive epidemic with more people dying from opioid overdose or related drugs than auto accidents in the U.S. I understand their concerns and degree of passion, but also would hasten to say that the FDA is working hard on this topic.
MH: What are your top three priorities on opioids?
Califf: We have a very specific action plan that has a lot more than three items. You could sort of put them into buckets. First is reducing the overprescription of opioids by providing practitioners and patients with better information. Second would be to prevent the deaths that are coming from overuse of opioids by making therapies like naloxone available on a broader basis. Third would be the development of abuse-deterrent formulations.
In the long term what we need is much more effective pain management as a national priority and the development of other therapies that are effective that are not addictive.
MH: What are your other top priorities?
Califf: The No. 1 priority during the time that I have at the FDA is strengthening the workforce. This means hiring top-notch people, because the world is changing so quickly with biotechnology and information technology coming together into an exciting revolutionary phase across the spectrum from agriculture to food products to medical products.
It also includes making the FDA as good of a place to work as possible for the highly talented people who are here. The FDA must evaluate increasingly complex information to make good decisions on behalf of the public. So we need the best people, and that includes keeping the pipeline full, but also keeping people happy when they work here.
The second big priority is what I will call evidence generation. We are in this amazing time where most everyone in the U.S. has an electronic health record. We have a massive number of registries being developed that deal with medical products. We have real-world information coming in from wearable devices and social media. Capturing that information, integrating it and making use of it is a big deal.
MH: Lawmakers over the past year have been pushing to streamline the FDA's process for reviewing drugs and medical devices through the 21st Century Cures Act. Are there ways the agency could expedite the review process without jeopardizing public safety?
Califf: We have to make sure the American public maintains confidence in the FDA. If the doctor prescribes a drug or puts a device in you, we don't want the public to have to stop and think, “Is this OK?” So safety is the No. 1 issue at the FDA. We are way ahead of other countries in terms of speed of review for drugs. We don't want anyone to believe we are going to approve everything. Some things should not be approved. The key is the timeline to reach that decision. We are faster than other countries, and the U.S. gets first market access more than any other country. With devices, we have had problems. We don't think our standards have been too high. We think other countries may need to up their standards a bit.
