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Agency IQ — FDA takes heat for missing diversity guidance deadline but commits to its release

Agency IQ — FDA takes heat for missing diversity guidance deadline but commits to its release

Quick background: FDA’s work to advance clinical trial diversity

  • FDA has demonstrated interest in racial and ethnic diversity in research studies for decades. The agency first issued guidance on demographic subgroup analyses in the 1980s. In the intervening years, FDA continued to update guidance in line with Office of Management and Budget (OMB) updates and Congressional directives. [ See AgencyIQ analysis for more detailed history of FDA’s policy and guidance on diversity in research studies.].
  • In April 2022, the FDA  issued a draft guidance document on diversity in clinical research programs. At a high level, the guidance laid out a policy whereby sponsors of certain products would voluntarily submit a Race and Ethnicity Diversity Plan that outlines and justifies their approach to recruiting and retaining a “representative” research population.
  • At the end of 2022, as part of the 2023 Consolidated Appropriations Act, Congress gave the FDA new authority to require what the law referred to as Diversity Action Plans (DAPs) for certain clinical studies. This section of the law amends the Federal Food, Drug and Cosmetic (FD&C) Act to expressly grant the FDA the statutory authority to require DAPs for 1) Drugs: for “a new drug that is in a phase 3 study” or “as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies)”; 2) Medical devices: As part of an Investigational Device Exemption (IDE) submission or “for any clinical study.”
  • The law also directed the FDA to “update or issue guidance” on DAPs. This guidance should include the specific format and content of the plans, such as the rationale for enrollment goals (e.g., estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.
  • The DAP guidance was due by the end of December 2023 – a  deadline that the FDA has now missed.
  • However, the agency did update a 2016 guidance on the Collection of Race and Ethnicity Data in January 2024. Read AgencyIQ analysis here.].

On Thursday, February 15, Friends of Cancer Research (FOCR) convened a virtual meeting on clinical trial diversity.

  • While the FOCR meeting did not provide additional details on the timeline or content of the DAP guidance, FDA was called out publicly by a prominent Democrat for missing its deadline. “They’re currently several weeks past December 29, 2023, deadline that Congress gave it to complete its important work, and you can be sure I’ll stay on this,” said Rep. ANNA ESHOO (D-Calif.), the ranking Democrat on the House Energy and Commerce Committee Subcommittee on Health, the committee with primary oversight jurisdiction over the FDA.
  • It’s worth noting that Eschoo isn’t a random legislator – she was one of the original co-sponsors of the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. That bill called was intended to enhance FDA’s ability to require the collection of specific diversity and demographic data in clinical trials. A modified version of the bill was eventually included in the Consolidated Appropriations Act, becoming law. [ Read AgencyIQ’s analysis of the DEPICT Act here.]
  • FDA Principal Deputy Commissioner and Acting Chief Scientist NAMANDJE BUMPUS followed with brief remarks reiterating the agency’s commitment to clinical trial diversity. She mentioned guidance and policy development efforts but did not go into detail on the specific documents in progress. Bumpus shared education and outreach activities, highlighting work by the Office of Minority Health and Health Equity to address enrollment barriers. She briefly acknowledged the requirement under FDORA for diversity action plans, saying, “Early and ongoing discussions with the appropriate FDA review divisions during drug development are critical to successful diversity action plans.”
  • LOLA FASHOYIN-AJE, formerly associate director of the Oncology Center of Excellence (OCE) and now with CBER’s Office of Therapeutic Products, was asked to provide an overview of FDA activities related to diversity plans to open the first session. She described the existing guidance on voluntary Diversity Plans, which she initially led development of, as “…an attempt to provide a framework for developing a prospective plan that includes explicit goals for enrolling a diverse population in clinical trials for drugs, biological products and devices.” Fashoyin-Aje’s remarks seem to indicate that the OCE experience reviewing these plans has been less than perfect, referring to a report published by the center. She explained, “…we have reviewed these and we have really gotten an experience from the sponsor side, I think, as well as well as the FDA, in really identifying areas that still need some clarification and or discussion…”
  • Regarding the Diversity Action Plan guidance document, Fashoyin-Aje did not provide an estimate for its publication or preview into its content. She acknowledged the missed due date, saying, “…we’re working very hard to get that out to our stakeholders.” That said, she said that experience and comments received on the Diversity Plan guidance have been informative to its development and “helpful in helping us to think through areas where we may need to provide more information about our thinking, or areas where we may borrow from to facilitate implementation in the context of FDA trials.” She later reiterated the broad contours laid out in the legislation for disaggregated enrollment goals, saying “Beyond that, I’m not I’m not sure I can really get into what those expectations would be.”
  • The other panelists offered different perspectives on methods to establish diversity enrollment goals. At a high level, stakeholders agreed that goals should be based on a variety of data types. ANNE-MICHELLE NOONE from the National Cancer Institute described potential opportunities to examine Medicare claims data to understand comorbidities in underserved cancer populations. CLEO RYALS from Flatiron Health argued that “…there’s tremendous opportunity and value in linking high quality clinical data from the EHR with robust genomic data, especially given the increased focus on biomarker driven drug development, and what we’re beginning to learn with regards to racial ethnic differences and tumor molecular profiles and biomarker status across a variety of tumor types.” Norvartis’ HENRY BENNET summarized the overall approach as a “triangulation” of available data sources.
  • Fashoyin Aje weighed in on the ideas from FDA’s perspective, saying, “We do recognize from our multiple forays into the use of real world data and data from electronic medical records that that information can be collected quite inconsistently. And so, our recommendation would be to follow FDA guidance on that particular topic.”
  • The second session of the event discussed strategies to sustainably engage diverse communities in clinical trial recruitment. The speakers, representing both community health leaders and industry, emphasized the importance of involving trusted messengers such as faith-based leaders and local providers with existing relationships. In addition, they discussed benefits stemming from network-based approaches, participation in local community events, and helping patients with trial-related financial burdens like transportation. Representing City of Hope Orange County, EDWARD KIM argued for reduced eligibility requirements for clinical trials to allow more diverse participation.