Rep. Anna Eshoo (D-CA) called out the FDA for having yet to publish guidance for industry on drafting diversity action plans for clinical trials during a Friends of Cancer Research virtual meeting Thursday.

In opening remarks, Eshoo, who chairs the House Energy and Commerce health subcommittee and is retiring at the end of this term, flagged that the FDA has missed its deadline to issue or revise its diversity action plans, and vowed to hold the agency accountable to comply with the law. Under the Food and Drug Omnibus Report Act (FDORA) of 2022, the FDA was mandated to revise or issue this guidance by the end of 2023 but still has yet to do so.

The FDA published draft guidance in 2022 directing companies to create diversity action plans in their clinical trials, but it has yet to either revise the draft or finalize it.

“I will hold the FDA certainly accountable to ensure it holds up its end of the law because patients and their families should not have to wait any longer to be part of life-changing clinical trials,” she said.

Eshoo also highlighted that for the drugs the FDA approved in 2022, caucasian patients made up the majority of those enrolled in those clinical trials. “Fixing this inequity is not only fair and just, it’s good science,” she said.

Namandjé Bumpus, the FDA’s newly minted principal deputy commissioner and chief scientist, also spoke at the virtual meeting, highlighting the Office of Minority Health and Health Equity’s program to find ways to boost clinical trial enrollment. She also mentioned FDORA’s diversity action plan requirement, but didn’t touch on the deadline.

“Early and ongoing discussions with the appropriate FDA review divisions during drug development are critical to successful diversity action plans,” Bumpus said.

https://endpts.com/eshoo-calls-out-fda-for-missing-deadline-on-diversity-action-plan-guidance/