Marylana Saadeh Helou, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Boston office, authored an article in Clinical Leader, titled “Summing Up the FDA's Long-Anticipated Draft Guidance on Diversity Action Plans.”
Following is an excerpt:
Nearly a year and a half after the Food and Drug Omnibus Reform Act of 2022 (FDORA, or the Act) was enacted, the FDA issued on June 24 its long-anticipated draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry.” The draft guidance, one of the FDA’s many ongoing efforts to address the participation of underrepresented populations in clinical trials, once finalized, will replace FDA’s April 2022 guidance on diversity plans for clinical studies.
FDORA, which was signed into law on Dec. 29, 2022, required, in part, that drug and device manufacturers submit Diversity Action Plans (DAPs) to the FDA for certain clinical studies involving drugs, biological products, and devices, unless otherwise waived or excepted. (This provision of FDORA was later incorporated into the Food, Drug, and Cosmetics Act [FDCA]. See Section 505(z) of the FDCA for drugs and Section 520(g)(9)(B) of the FDCA for devices.) Such DAPs needed to clearly outline the clinical study sponsor’s goals, rationale, and approach for enrolling participants who are members of historically underrepresented populations to help improve the strength and generalizability of the evidence for the intended use population. The Act also required the FDA to issue or update guidance on the content of the DAPs within one year.
The draft guidance clarifies which clinical studies require DAPs, what should go into a DAP, and how and when DAPs should be submitted to the FDA. Additionally, the FDA includes a helpful appendix that summarizes the elements of a DAP. Notably, however, the agency did not comment on the consequences if a sponsor fails to meet its enrollment goals, including whether noncompliance could slow the drug or device approval process. FDA instead simply stated, “If such goals are not on track for being met at the conclusion of the study, the status report should include a description of the reason(s) the sponsor is not currently meeting or does not expect to meet enrollment goals and the sponsor’s plan to mitigate such an outcome.”
