Policymakers and biopharma companies acknowledge the importance of assessing drugs and medical products on a wide range of ethnic and racial populations to fully understand medical effects on patients. This has bolstered support for studies to enroll patients in proportion to the prevalence and burden of the disease in relevant subgroups, but achieving such equitable patient representation in clinical trials has been difficult and uneven, at best.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policymakers have added a “stick” to the process: research sponsors now will be required to tackle this issue by submitting Diversity Action Plans (DAPs) to the agency when proposing and seeking approval of Phase III and pivotal studies. This provision was included in the Food & Drug Omnibus Reform Act (FDORA), approved by Congress in December 2022 as part of the massive Consolidated Appropriations Act that authorized federal spending for 2023.

Among a host of FDORA provisions, including those designed to modernize FDA’s accelerated approval program, bolster FDA inspections, and expand oversight of cosmetics, the legislation also requires DAPs that set specific enrolment goals for clinical trials of most drugs and certain medical devices under development. FDA has a year to issue guidance on the program, and there may be some waivers and exceptions, as for bioequivalence studies. But diversity plans will be required for most clinical development programs. FDA will hold a public workshop on the program, issue additional guidelines on specific topics, and submit annual reports to Congress once the program gets going.1

Read more here.

References

  1. Wechsler, J. (2023, February 13). Clinical Trial Diversity Continues to Face Challenges. BioPharm International. https://www.biopharminternational.com/view/clinical-trial-diversity-continues-to-face-challenges

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