Bumpus discusses adcomms, animal testing, and AI

WASHINGTON – The second-in-command at the US Food and Drug Administration (FDA) said she wants to use advisory committees to address broader scientific issues, addressed animal testing alternatives in the preclinical space, and said she is happy to continue serving the agency if the current commissioner steps down.

Namandjé Bumpus, FDA principal deputy commissioner, made these remarks during an interview with AgencyIQ’s Alexander Gaffney at the 2024 Politico Health Care Summit. When asked about advisory committee reforms, she said it’s part of the agency’s ongoing effort to reevaluate how it does its work and that it wants to ensure that the advisory committee process is as efficient and effective as it can be.

“Advisory committees are a ripe opportunity for that because it's so important for us to be getting access to the most up-to-date scientific knowledge,” said Bumpus. “We do have world-leading scientists inside FDA, but we certainly want to make sure we're talking to those folks outside that have expertise and perspectives that may make us think about things in certain ways or may introduce us to certain topics.”

Bumpus added that she’s been looking at FDA’s internal logistics to ensure that the agency can identify the right experts, ways to enhance their onboarding process so it's seamless and enjoyable, and ways to engage the experts on broader scientific topics.

“There are cross-cutting topics that I think advisory committees can give us a lot of input into,” she added.

Bumpus was asked about the FDA Modernization Act 2.0 passed by Congress in 2022 as part of the 2023 omnibus spending bill . The law gives FDA authority to allow certain alternatives to preclinical animal testing, including cell-based assays and computer models, when sponsors are developing new drugs and biologics.

While she said FDA is researching alternative methods to animal testing, the technology is still not there to be able to replace such testing in many cases.

“Science is not at a place to fully be able to replace animal testing in instances we're thinking about,” said Bumpus. “There is still use for animals in research. I think we can reduce, refine, replace certain tests and we're very committed to that.”

When asked about how artificial intelligence (AI) can transform FDA and whether the agency has the expertise and capacity to handle AI product reviews, Bumpus noted that the agency is already reviewing products with AI and that it has AI experts handling those applications. However, she added that as the field grows, the agency will also need to grow capacity and expertise in the area.

Gaffney asked whether Bumpus would consider the FDA Commissioner role in the event of a second Biden administration, noting that FDA Commissioner Robert Califf has hinted that he might not stay on. Bumpus said she would be willing to serve in any capacity asked of her.

Bumpus discusses adcomms, animal testing, and AI

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