Califf Returned to FDA for ‘Unfinished Business’
Robert Califf admits that his return to the FDA top post gives him an opportunity to address “unfinished business from the first time around,” when he served as commissioner during the final year of the Obama administration (2016 to 2017). In an JAMA online interview with deputy editor Greg Curfman, Califf confessed: “I am 70 years old — I thought I’d be on the front porch in a rocking chair at this point in my life…[but] I’m thinking about my kids and grandkids and things that need to be done.”
Califf said he is still “emboldened to enhance the mission that I had in 2016, which is to develop the infrastructure at FDA. I think I can do it with a lot more intensity now. The FDA is an amazing decision-making machine full of talented people that makes hundreds of decisions every day, but it needs an upgrade in technology and data systems to function at its peak.”
Asked to opine on the current state of evidence generation, Califf contrasted how studies progressed during the pandemic here in the U.S. and the UK. “In the U.S., we had thousands of clinical trials that were started, most of them by local investigators with topics of interest to them and supported by their institutions,” he explained. “Many thousands of patients volunteered to be in those clinical studies. In the UK, basically the message was, ‘We have to work together to answer the most important questions. It’s part of your mission as an employee of the National Health Service to participate as a doctor or a nurse.’ And patients were encouraged to enroll in studies that were greatly simplified to make sure that the important questions were answered with an adequate sample size and number of events.
“Most U.S. studies either never finished or didn't answer an important question,” Califf continued. “The UK reeled off important result after important result. Now I’m not arguing we should do away with the investigator-initiated small studies; they’re a real contribution of the U.S. But what we don’t need is a study that doesn't really have a hope of answering a major question because the sample size is too small or the design is not appropriate. We have way too many of those. When there are important public health questions, we have to figure out how to reward the investigators for participating and trim down all the unnecessary bureaucracy to make sure we get the answer as quickly and as definitively as possible.”
Additionally, Califf was asked how FDA plans to address harmful misinformation, which he pledged to make a priority during his confirmation. After being sworn in, he released a statement on his Twitter account (@DrCaliff_FDA), saying he aims to counter “misinformation about science and the FDA that has become increasingly prevalent. These kinds of distortions and half-truths that find their way into the public domain do enormous harm, both by leading people to behavior that is detrimental to their health and by causing them to eschew interventions that would improve their health.”
In the interview, Califf said to stay tuned. “I haven't talked to anyone who has the solution yet. So we are going to come up with a plan. People should know that Surgeon General Vivek Murthy, has made this a priority, and we will have a plan to deal with misinformation. We have to be out there 24/7 with correct information. That means we can't just make a decision about a product and put out one statement. We have to elevate reliable, truthful information. And whether it's disinformation or purposeful intent to hurt people, we have to go after that aggressively. We need the medical profession, universities, and health systems to wake up about misinformation in general and become much more actively involved. This is not something the FDA can do alone.”