ARTICLE SUMMARY:
Lawmakers pressure FDA stalled diversity guidance. Excerpted from Pathways' Picks February 28: Down to the Wire On EPA Sterilization Rule and US Government Funding.
Lawmakers are pressing FDA to publish a draft guide describing how companies should develop mandatory clinical trial diversity action plans. The Food and Drug Omnibus Act of 2022 required the agency to issues such a draft guidance by December 29, 2023, but it has yet to release it. “The failure to meet this critical deadline delays the implementation of important efforts to improve diversity in clinical trials,” Reps. Frank Pallone (D-NJ), Anna Eshoo (D-CA), and Kathy Castor (D-FL), all Democratic leaders in the House Energy and Commerce Committee, wrote to the agency February 20. The legislation added new requirements for device and drug companies to map out and submit their strategies for ensuring appropriate subpopulations are enrolled in clinical trials, but the mandate won’t kick in until 180 days after a guidance is finalized. FDA officials have publicly confirmed they are working to get the draft guidance out soon.