DIA Annual Meeting: CBER Head Predicts Agency’s Guidance Process Will Be Changed by Pandemic

The FDA has been forced to streamline its guidance development process during the COVID-19 pandemic, and the change is likely to shape its approach beyond the pandemic, says Center for Biologics Evaluation and Research (CBER) Director Peter Marks.

“If this [pandemic] was over tomorrow and I had to say one thing I think is going to look very different … it’s how we develop and get out guidance,” Marks said during the final session of the Drug Information Association (DIA)’s annual meeting.

“What we have done in the past six months is guidance development, which used to be something that I personally found challenging, somewhat painful and tortured at times, the way we did things. [It] has become very streamlined,” he said. “People come to agreement very quickly because we get out our differences quickly. We say what we mean, and we mean what we say, and that’s been really helpful.”

The timelines for guidance development, which had previously been years for many documents, had to be condensed down to a fraction of that time — in some cases two or three weeks — during the crisis. Marks said the current streamlined process may be superior to the old one.

“When you look at guidance that’s been produced after two or three weeks of hard work … if anything, the shorter process might be a better one because it’s fresh,” he said. “For a lot of what we’re doing, at least in the CBER world, things are evolving so quickly that things that have taken two to three years to develop are often almost outdated by the time they’re published.”

Looking forward, Marks said he believes the agency’s ability and desire to hold more ongoing communications with sponsors will persist beyond the pandemic.

Earlier this month, FDA Commissioner Stephen Hahn told participants in a virtual event hosted by the Alliance for a Stronger FDA that the agency’s response to the pandemic will lead to permanent improvements.

“I am committed to making sure that some of the lessons learned from managing this pandemic will lead to permanent improvements at the FDA in processes and policies,” Hahn said (DID, June 4). — James Miessler