Audience Question: FDA has gone through a period of significant growth . . . it was recently reported that 38% of medical reviewers have been on the job less than two years . . . how well are these staff being integrated . . . and what do you view as the opportunities and challenges of having new staff?
D.T.: It’s something that Dr. [Janet] Woodcock and I talk about a great deal. We know that inconsistent application of policy is not going to be helpful in terms of product development . . . first off, making certain that people know the policies are are applying them correctly is terribly important. . . .
We’re in the process of first inventorying our training . . . to sit down and look soup to nuts at what training people get when they come in . . . importantly, we have to tell them what it is we don’t expect them to know. . . .we want that those trained reviewers are comfortable asking questions and are open to new scientific information as it becomes available. . . .
We have a two-hour meeting every Friday (called “regulatory briefings”) where we [the CDER leadership] hear about and discuss the hard decisions [FDA staff] are having to make. . . . The room is now overflowing . . . we’re seeing over 100 people coming to that meeting every Friday . . . these are predecisional meetings . . . they have the form of a large hallway conversation.
K.M.: It’s important to have mentoring in place . . . having the resources to discuss with others . . . having the opportunity to have the bigger sense of how questions fit in with policy and guidance development.
Audience Question: Public safety is the raison d’etre . . . how do you balance the safety aspects with allowing new and enabling ideas to be advanced?
K.M.: We grapple with that because we really have some novel products . . . we try to have a lot of collaborations with other stakeholders to really try to develop some of these things . . . you want to give good guidance, but sometimes the best guidance is based on experience, so it’s kind of a chicken and egg kind of thing.
D.T.: It’s a great question. It goes back to the training question, and making sure that our people are open to new ideas and new science . . . it’s about making certain that everyone’s willing to question their assumptions.
You can think of a lot of places where that happens . . . for example, how do you best use the “animal rule” for anthrax testing when human exposure is just not possible . . . I don’t know that you can write down on a piece of paper exactly how you do that, but you need to talk with people with open minds and be willing to question your assumptions.
Audience Question: How is the “Equal Voice Initiative” that you started a couple years ago going? How are you balancing trying to train a bunch of people and allowing this equal voice to happen?
D.T.: Equal Voice is to make sure that all of the various discliplines are given their due in decisionmaking. It’s an expertise-based discussion . . . if you don’t have the experts you need at the table, then you’re not having a full conversation . . . if there is an office that feels they’re being excluded, then that needs to be changed right away.
Audience Question: With the globalization of clinical trials, what trends are you seeing in terms of policy changes?
D.T.: First off, we’ve been fortunate to be relying upon global health data for clinical trials for many years . . . we’re completely supportive of the need for medical products’ data coming from outside the country . . . having said that, we have found that the use of products outside the U.S. may not inform the use of those products inside the U.S . . .
K.M.: Having trial information from around the world is very important . . . and in some cases, such as vaccines, that information may only be located in other areas . . .
Audience Question: Regarding a biosimilars pathway, do you have an idea when regulations will be published?
K.M.: We really have just begun. We recognize there is going to be a need for guidance . . . but we are just beginning to assess what it is that might need those things. . .