Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

January 24, 2023By Faraz Siddiqui & Deborah L. Livornese

Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).  This requirement, enacted under section 3601 of Food and Drug Omnibus Reform Act (FDORA), will apply to clinical trials that commence enrollment 180 days after FDA finalizes guidance on the topic.

FDA’s Past Efforts on Clinical Trial Diversity

In 2013, at Congress’ behest under the Food and Drug Administration Safety and Innovation Act (FDASIA) section 907, FDA published a report on the demographic makeup of research subjects that participated in the pivotal clinical trials of recently approved medical products (see our earlier post on FDASIA section 907). The report reviewed clinical trials for seventy-two drugs, biologics and Class III devices that were approved by the agency in 2011 for whether those trials collected and reported research subject demographics data, whether they analyzed research outcomes by demographic subgroups, and the extent to which traditionally underrepresented demographic subgroups were included in those trials.  The report bore out what many in the industry and academia already knew—while some sponsors were able to recruit subjects that reflected the distribution of the disease in the population in terms of age and sex, participation by racial minorities and other socially disadvantaged subgroups was lacking.

Since that report, FDA has undertaken numerous initiatives to encourage diversity in clinical trials.  In 2014, FDA released the “FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.” FDA declared 2016 the “Year of Clinical Trials Diversity” and that year, issued two guidance documents, one for drug and one for device studies, to standardize collection and reporting of race and ethnicity data in submissions for clinical trials (see our blog post on the final device-related guidance here). The following year, Congress enacted the FDA Reauthorization Act of 2017 (FDARA), which required FDA to publish guidance to enhance diversity in clinical trials.  This guidance was finalized in 2020.

The COVID-19 pandemic temporarily halted many clinical trials and left an indelible mark on clinical trial recruitment.  The challenges of the pandemic may have affected participation by underrepresented participants even more than other groups.  For example, it is unclear if the use of telehealth services and remote monitoring increased access to clinical trials for the elderly and disadvantaged.  Even COVID-19 trials were reported to be insufficiently diverse, despite the fact that racial and ethnic minorities were disproportionately affected by the disease.

More recently, in April 2022, the agency issued draft guidance recommending sponsors to develop Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials. Now, FDORA makes these plans mandatory for most drug and device studies.

Clinical Trial Diversity Under FDORA

FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).  This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol.  Another new subsection 520(g)(9) similarly requires sponsors of device trials to submit diversity action plans.  Devices that require an Investigational Device Exemption (IDE) application must submit a diversity action plan with that application, whereas sponsors of device trials that do not require an IDE will need to submit a diversity action plan when they submit their 510(k), requests for classification, or premarket approval application.

FDORA specifically exempts submissions made under the expanded access provisions of the FDC Act from having to submit diversity action plans.  The requirements also do not apply to a discrete set of device studies exempted from IDE requirements under 21 C.F.R. § 812.2(c).  These include pre-amendment devices, cleared devices used on label, certain diagnostic devices, custom devices, veterinary use devices, devices for research with laboratory animals, and certain devices undergoing consumer preference testing or modification testing.

FDA can waive the requirement to submit a diversity action plan on its own initiative or at the request of a sponsor.  To grant a waiver, FDA must determine that the prevalence or incidence of the disease or condition being studied makes it impracticable to conduct a clinical trial in accordance with a diversity action plan, or that a waiver is necessary to protect public health during a public health emergency.  If a sponsor requests a waiver, FDA must grant or deny a waiver within 60 days of receiving such a request.

The Format and Content of Diversity Action Plans

Section 3602 of FDORA requires FDA to issue or update guidance on the format and content of diversity action plans within twelve months of its enactment (i.e., by the end of 2023).  The Act provides a lot of detail in what the guidance—and in turn, diversity action plans— should cover.  Many of these details track what FDA already recommends in the April 2022 draft guidance.  Diversity action plans should contain (1) the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic characteristics; (2) the rationale for these enrollment goals, including information about the disease or condition and its prevalence or incidence among various demographics; and (3) how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, inclusion and exclusion practices, and diversity training for study personnel.

FDORA also requires the guidance to cover issues regarding FDA’s criteria in assessing sponsor waiver requests, public posting requirement of key information from diversity plans, the process to submit diversity action plan updates and modifications, reporting a trial’s progress towards its recruitment goals, and notifying FDA of a sponsor’s inability to reach those recruitment goals. FDORA requires FDA to finalize such guidance within 9 months of the closing of the comment period for the draft guidance.

Public Workshop and Congressional Reports

FDORA requires FDA to convene public workshops and solicit comments on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study diversity, and publish a report on the recommendations raised in the workshop.  Finally, FDA must submit an annual report to Congress summarizing the Agency’s aggregated experience with sponsors’ diversity action plans beginning not later than early 2025.

More about FDORA

Please see out blog post here to obtain a copy of HPM’s detailed Summary and Analysis of all the provisions of FDORA.