With a new presidential administration next year, FDA Principal Deputy Commissioner Namandjé Bumpus would be in line to lead the agency if current Commissioner Robert Califf steps down after the election next month.
Califf has said that he’s committed to staying in the job only until the election, and top administration appointees often step down during the lame-duck transition. Bumpus, the FDA’s former chief scientist, sat down on Wednesday with Endpoints News for a Zoom interview to talk about her priorities.
Bumpus spoke with Endpoints about accelerated approvals, foreign inspections, diversity in clinical trials, advisory committee votes and more. This conversation has been significantly edited for length and clarity.
Zachary Brennan: We’re coming up on the election in about a month, and Dr. Califf has only promised to stay until just after. You’re next in line to be acting commissioner. Are you preparing?
Namandjé Bumpus: I am focused on being principal deputy commissioner. I get that question a lot, and certainly there are processes the agency has to go through for that transition. But my focus is on this role.
A lot of what I do is in operations, helping the agency run day-to-day, working on the reorganization in the Office of Regulatory Affairs, helping advance the work of Office of Inspections and all of our centers and human foods program. I really do have an operations-type focus, and I think that it’s allowed me to be a good complement to the commissioner.
Brennan: You co-authored a recent Nature commentary on advisory committee reforms. Which reforms do you think will lead to the most major changes? And will there be any changes to the voting process or in determining how FDA decides to use a vote?
Bumpus: We are still working through and considering all the feedback stemming from the public meeting last June. It’s going to evolve, and we continue to make enhancements. Our process for recruitment of advisory committee members and how we identify experts, I really think, is critical to ensuring that we have a broad view of who’s out there, and who really could give us useful advice and information.
Voting has not been a mandatory part of advisory committee meetings and it really depends on the meeting. I think that voting does have an important role in helping understand where individual members fall on specific questions and where the committee’s leaning.
So what I’m thinking about is: How do we ensure we’re framing questions in a way that we get the feedback that we need? If we ask for a vote, is it very clear what the meaning of the vote was? But discussion is really what we get so much from. These are very nuanced, complex topics, complex science, and the rich discussion is what really gives the FDA information we need to ultimately make our decision.
There’s opportunity for using advisory committees for broader topics and broader scientific topics around clinical trial design, for instance, the development of endpoints and surrogate endpoints.
Brennan: We’ve seen reforms from Congress that FDA has been implementing around accelerated approval to speed up confirmatory trials and ensure they’re enrolling once the approval arrives. But we’ve also seen two accelerated approvals recently converted to full approvals after the confirmatory trial’s primary endpoint was found not to be statistically significant. Can you talk about what goes into a decision like these and how trials that might be considered a “failed” trial could potentially convert an accelerated approval to a full approval?
Bumpus: As the science evolves or we understand more, you learn more about an endpoint and how robust it might be. You learn more about the biochemistry, and that’s something that just evolves over time. Often we’ll have communication around what types of studies we think are needed to further that understanding.
Our review divisions have tremendous expertise, and are in close discussion on those topics. But we are always working to try to see what the next frontier is, and make sure that we’re thinking about it in the most innovative way. We make our decisions based upon what’s in front of us, and as we believe that there are additional studies needed, we ask for those studies.
Brennan: On this idea of following the science, we saw the Supreme Court overturn the Chevron doctrine. Are you concerned that courts may rely on FDA’s expertise less? And are you concerned about FDA’s ability to regulate the pharma industry because you’ll have to rely more on guidance versus rulemakings, or vice versa?
Bumpus: We at FDA, along with HHS and DOJ, continue to try to assess the impact of the Loper Bright decision, and that the legal underpinnings of our regulations, guidance and decisions allow us to continue to take action that’s driven by and based on the science.
The thing that I really want people to realize at FDA is that science is the thread across everything we do. We have scientists here who are not only evaluating things, but also are generating knowledge people use and that we use in our decision-making.
Brennan: Last Friday, Dr. Califf in an interview raised a few questions about America’s reliance on China and India for pharmaceuticals and ingredients. He expressed the need for the US to onshore more manufacturing. I’m curious to hear what role you think the FDA has to play in this space?
Bumpus: I’m aligned with the commissioner on his views there. Science is a global industry, and certainly there’s opportunity for collaboration and learning. Thinking about other countries and our interactions with them and foreign inspections, we have increased our expertise and effort around data and continually enhancing and improving our foreign inspections capability. I certainly second the commissioner’s comments that you’re referencing.
Brennan: We’ve seen some movement at FDA around diversity in clinical trials and diversity action plans that have been proposed. Do you think these action plans are going to really encourage sponsors to increase the diversity?
Bumpus: We want to look at these data, disaggregated by race, ethnicity, sex and age group, but even getting to a point where we’re ensuring that we see, for instance, older adults across all of the ethnicities and races that we’re looking at.
As far as the diversity action plans, we have a draft guidance that we published, and the comment period closed Sept. 26. We will be analyzing comments and developing final guidance as expeditiously as possible.