House Subcommittee Chair Introduces Clinical Trial Diversity Bill
The chair of the House health subcommittee along with two of her House colleagues have introduced bipartisan legislation that would require sponsors to report clinical trial enrollment targets by demographic group, including age, race, ethnicity and sex.
The legislation, dubbed Diverse and Equitable Participation in Clinical Trials (DEPICT), is the fourth bill introduced in this Congress calling for increasing diversity in clinical trials. It was cosponsored by Reps. Anna Eshoo (D-Calif.), chair of the House subcommittee, Brian Fitzpatrick (R-Penn.) and Robin Kelly (D-Ill). No further action has been scheduled for any of the bills.
In addition to reporting enrollment data, the legislation would require investigational new drug (IND) and investigational device exemption (IDE) applicants to provide the rationale behind their targets. It would also require them to submit a diversity action plan for meeting their enrollment goals.
In addition, the FDA would require postmarket studies when sponsors don’t meet their diversity targets and fail to sufficiently justify this failure. The bill also requires the agency to put together a yearly report that aggregates and analyzes the data provided by sponsors on their trial diversity efforts.
The bill was circulated within industry in late 2021, receiving feedback from the Biotechnology Innovation Organization (BIO) and the American Geriatrics Society.
Three other bills were introduced last year that aim to increase the diversity of clinical trials:
- House and Senate versions of the DIVERSE Trials Act (H.R. 5030 by Rep. Paul Ruiz (D-Calif.)/S.2706 by Sen. Robert Menendez (D-NJ), introduced in August 2021.
- House and Senate versions of the ENACT Act (H.R. 3085 by Rep. Lisa Blunt Rochester (D-Del.)/S. 1548 by Sen. Ben Ray Lujan (D-NM), introduced in May 2021.
- The Cures 2.0 Act (H.R. 6000) by Rep. Diana DeGette (D-Colo.), introduced in November 2021.
In November 2020, the FDA issued trial diversity final guidance that is aimed at making sure sponsors are taking measurable steps to improve the diversity of their trials. Here is a link to that trial guidance: https://bit.ly/3grfZVo.
Read the text of the DEPICT Act as it currently stands here: https://bit.ly/3J4NLfv.