BIO 2010: FDA’s Midthun, Throckmorton on Increasing, and Integrating, the Agency’s Expertise

During an FDA Town Hall meeting at BIO 2010 today, FDA’s Karen Midthun (Acting Director, CBER), and Douglas Throckmorton (Deputy Director, CDER) fielded questions from the audience about current regulatory issues. What follows is a brief synopsis of this session:

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. . .

--Paul Thomas