PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Feb 3, 2022
Diverse and Equitable Participation in Clinical Trials Act or the DEPICT Act
This bill requires applications for an investigational use exemption of a new drug or medical device to include information about the demographic diversity of the clinical trial population and addresses related issues. (Generally, a developer of a new drug or device may seek an investigational use exemption to facilitate clinical investigations, as part of the process to obtain approval to sell that drug or device.)
Specifically, the Food and Drug Administration (FDA) must issue regulations to require applications for such exemptions to include certain information, including (1) demographic data disaggregated by subgroup, where such data is available, about the expected or potential patient population; (2) the applicant's enrollment targets for the clinical trials involved, disaggregated by age group, sex, race, and ethnicity; (3) a diversity plan for how the applicant will meet these targets; and (4) what is known about the patient population, such as comorbidities.
Showing the opening paragraphs of the official summary.
The regulations must also require certain applicant reports to the FDA to address issues related to demographic diversity in clinical trials and product safety and effectiveness for demographic subgroups.
The bill also authorizes the FDA to, in certain instances, require additional studies or surveillance after a drug or device has been approved if the clinical trials used in the application process did not meet the demographic enrollment targets.
People & committees
Rep. Eshoo, Anna G. [D-CA-18] · D–CA
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We currently store references to these documents.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Apr 7, 2025. Consult Congress.gov for the current record.
AI Conversation Starters
Choose a perspective, copy a prompt, and paste it into your preferred AI. Each prompt includes the bill version and available official source links, and asks for counterarguments as well as supporting evidence.
Analyze H.R.6584 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine H.R.6584 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
Examine H.R.6584 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
Examine H.R.6584 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.