CBER Director Prasad on Striking the Right Data Balance
New CBER director Vinay Prasad says he is not “anti-vax” and promises that the Center will strive to “always strike the balance between data, evidence, innovation and entrepreneurial spirit of America.” In a 5/8-posted video conversation co-hosted by FDA commissioner Marty Makary and FDA Policy and Research Strategy associate director Sanjula Jain-Nagpal, Prasad defended his past criticisms of the vaccine space. “I think vaccines are like drugs, which is that when given at the right time, at the right moment to the right person, they’re lifesaving,” Prasad said. “But just like drugs, they need to be evaluated on a case-by-case basis… Marty and I, throughout the pandemic, were proponents of vaccines for the people in whom it had a huge benefit, but we were always a bit skeptical, from a scientific standpoint, about perhaps overdoing it in some low-risk population.”
Instead of being known as anti-vax, Prasad characterized his stance as “pro-science, and trying to bring the best available science to answer the questions.” He blamed the media for misrepresenting the “concepts that we’re talking about at FDA. They have sort of a superficial view of what we’re doing, and in some ways, they kind of miss the mark… Probably few doctors have given as many vaccines as I have… So, you know, we love vaccines when done right, when given appropriately, when based on solid evidence. And we’re going to hold up that standard at FDA.”
Presumably reflecting on the Covid-19 vaccines and FDA’s recent decision to require more clinical data on the revised booster shots, Jain-Nagpal asked Prasad to explain this “different standard of evidence” he would like to begin seeing. “We all continue to believe in a flexible regulatory standard taking into account the context of a disease, whether it's rare, if it's dire, and we will continue to be flexible,” he responded. “There’s not going to be a light switch change here. But around the edges, I think there were a number of missteps along the way. I think the public recognizes those missteps…As Marty points out, 85% of health care workers don’t want a booster that the FDA granted authorization for, and we really aren't sure about kids and how many doses they need, and healthcare workers who just had Covid and whether they need another booster. And these are important scientific questions that the public deserves an answer on. And there we might try to bring science in to answer these questions.”
FDA must also have regulatory flexibility for rare diseases that severely impact small numbers of patients and where requiring a randomized clinical trial might be difficult or impossible to do, Prasad contended. “We need to embrace new technologies, and innovative pathophysiology in terms of how to assess those products,” he said. “And at the same time, we also want to protect those patients from potentially harmful products, so we will continue to strike the balance at FDA between those two things I think FDA has always been committed to being flexible and listening to the communities impacted by rare conditions.”
During the discussion, Makary addressed artificial intelligence (AI) and the agency’s initiative to have AI-assisted scientific reviews (see earlier story). He said he is “very excited” about its potential and said that during a pilot review, one section of the submission reviewed was reduced from three days down to six minutes. “I’ve heard reviewers tell me that they’re reading so many things. Some stuff is just repetitive, and if AI can create and prep all the unique facts and summarize them for the reviewer, … maybe reviews can be done faster… And most importantly, they’ll love their jobs more. I mean, that's what we have to do and that's our job as leaders to make a great workplace culture for people, where they can focus on their superpowers, do their job, do their job well, support them, not burden them with red tape and busy work.”