From Draft Guidance to Law – Clinical Trial Diversity is Here To Stay

On December 23, 2022, the U.S. Congress passed the Consolidated Appropriations Act, 2023 following passage in the House by a vote of 225 to 201.

The Consolidated Appropriations Act, 2023 (aka omnibus) is a $1.7 trillion omnibus spending bill, funding the U.S. federal government for the 2023 fiscal year. It includes funding for clinical trial diversity legislation such as the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act and the Diversifying Investigations Via Equitable Research Studies For Everyone (DIVERSE) Trials Act.

As a change agent in the life sciences industry, WOCIP provided recommendations to the sponsors of the DEPICT Act in August 2021, prior to the Bill’s introduction to Congress on February 3, 2022. DEPICT directs the FDA to issue regulations requiring sponsors to develop a diversity plan for clinical trials and gives the agency the authority to mandate post-approval studies or post-marketing surveillance if the clinical trials conducted to support a drug application did not meet the enrollment targets.

Under the new omnibus legislation, Pharmaceutical and Biotech companies are now required to submit diversity action plans for phase III or pivotal trials. These plans should include specific enrollment goals and supporting rationale. Per the legislation, plans “shall apply only with respect to clinical investigations for which enrollment commences after the date that is 180 days after publication of final guidance required under this section.”

The FDA will be tasked with analyzing the plans provided by sponsors and publishing annual aggregate reports for approved therapies. Reports have to be submitted to Congress. FDA is also required to conduct one or more public meetings to solicit input from all stakeholders on ways to increase clinical trial diversity.

It is important to note that the Omnibus legislation failed to give FDA the authority to mandate post-marketing studies for companies that do not meet their diversity plan goals.

We acknowledge and celebrate the current progress; however, we also reiterate there is much more work required. WOCIP’s original recommendations included additional measures to ensure equity in the entire drug development ecosystem, as well as incentives that mirror those for companies developing drugs for rare diseases. With the history of longstanding inequities and social determinants of health, it is critical that historically underrepresented populations participate fully in clinical trials and that data from approved therapies reflect the prevalence of the disease or condition among demographic subgroups.

We encourage active participation in all upcoming public workshops held by the FDA. Will you be there?