"Unscripted, No Makeup, Live from the FDA." - Commissioner Makary launches "FDA Direct" podcast.

Last week marked the first episode of FDA's newest podcast hosted by FDA Commissioner Martin Makary, along with the newly appointed director of the Center for Biologics Evaluation and Research (CBER), Dr. Vinayak "Vinay" Kashyap Prashad and Sanjula Jain-Nagpal, Associate Director of Policy & Research Strategy, Office of the Commissioner (OC).

Clocking in around 23 minutes, overall, the podcast episode focused on the importance of innovation, opportunities for "closing the gap" between the pace of innovation and the advancement of government policy, and the importance of flexibility in regulatory decision-making. The must-cover topic of AI was also discussed, in particular, FDA's pilot project of AI-assisted product review. Here are a few more details:

• Clarification of vaccine stance: In response to assertions that previous approaches during the pandemic have been "anti-vax," Dr. Prashad clarified that "vaccines are like drugs," which "given at the right time, at the right moment, to the right person, they're life-saving, but just like drugs, they need to be evaluated on a case-by-case basis and always take into the context that you're giving." He described his and Dr. Makary's approach during the COVID-19 pandemic as not "anti-vax" but "pro-science," expressing skepticism of "overdoing it" in some low-risk populations.

  
  

• Balancing pace of innovation with scientific rigor in moments of crisis: Dr. Makary discussed FDA's new post-approval monitoring process where FDA can conduct big data analyses of safety and efficacy signals after approval, providing FDA with "a new lens that we never had."

  
  

• Regulatory flexibility: Dr. Prashad urged the need for "tremendous regulatory flexibility for rare diseases that severely impact small groups of people where running randomized clinical trials might be very difficult or impossible to do," and "to embrace new innovative technology in pathophysiology in terms of how to assess those products," while also protecting patients from potentially harmful products.

  
  

• AI-assisted FDA review: Dr. Makary said "day one, we said we gotta stop just talking about AI, having conferences and panels and framework and consensus documents . . . we have to actually do it." FDA started a massive initiative and announced the first high-level AI-assisted scientific review, and the "scientific reviewer loved it." The AI-assisted review pared a step of data review that would have taken three days down to six minutes. Dr. Prashad discussed the potential of leveraging AI to help cut review down to most important parts to "tremendously speed up drug regulation and drug processes."

  
  

• Moving to surprise foreign inspections: The episode discussed FDA's shift to surprise foreign inspections, explaining that currently for foreign inspections, inspectors are met with the "red carpet" and a "limo", where everything is cleaned up because an inspection is expected: "the element of surprise is what drives the power of an inspection. And that's a big part of what the FDA does."

  
  

Dr. Makary discussed offering a space for the media in future podcast episodes, and in the interest of increased predictability in FDA's approaches, mentioned hosting a roundtable in the next few weeks with the media, patients, patient advocacy groups, and the industry to discuss future topics.