FDA is considering how real-world evidence (RWE) can be used to update product labels, and labeling may be the first area in which the agency develops a clear framework for the use of real-world evidence, agency Commissioner Scott Gottlieb told a group of stakeholders during Friends of Cancer Research’s (FOCR’s) annual meeting.
“As we think about how do we keep product labels up-to-date, more and more we’re going to be relying on practical evidence developed in real-world clinical practice. And applying those principles, it might be that the first place where we develop a very clear framework for how we use real-world evidence … will be in the context of how we can also be proactive about making sure that labels stay up-to-date so I think that we have a confluence of two big opportunities. One is to think of a different paradigm for how we can continue to make sure labels reflect the current state of science and how we think about trying to create clear guidelines for how we incorporate real-world evidence in practical clinical data in the regulatory process,” he said.
During a panel later in the day, FOCR President and CEO Jeff Allen asked FDA’s drug center director Janet Woodcock whether RWE could play a role in updating labeling.
Woodcock agreed with Gottlieb that RWE may be useful for updating labels, but cautioned that someone still has to put the effort in to initiate the change — and that might pose a difficulty for off-patent drugs.
“Regardless of the quality of evidence, the other barrier to getting the label updated still exists, which is all this effort has to be put together to write up the evidence, submit it, the fact that if it’s an off-patent drug and the RLD has been withdrawn or even if it hasn’t but the sponsor isn’t interested, then nobody is going to put in any effort. But I do think we will, if we’re successful in using clinical practice as a source of evidence generation by bringing the clinical research enterprise closer together with practice, we will be generating more information … And I think some of that information will rise to the level of robustness that it certainly could go in the FDA label, but then who’s going to put it there” Woodcock said.