# The DEPICT Act: Making Sure New Medicines and Devices Work for Everyone

Right now, when pharmaceutical companies test new drugs and medical devices before getting FDA approval, they often don't include enough diverse participants. This means we don't always know if a medication works the same way for different racial and ethnic groups, older adults, or people with different body types. The DEPICT Act (Diverse and Equitable Participation in Clinical Trials Act) tries to fix this problem by requiring companies to be more intentional about who they include in their clinical trials.

Here's what the bill actually requires: When a drug or device company applies to test a new product on humans, they now have to submit a detailed plan showing how many people from different age groups, races, ethnicities, and sexes they expect to enroll. They need to explain why they chose those numbers—whether it's because the disease affects certain groups more, or because of other scientific reasons. They also have to describe their specific strategy for recruiting diverse participants, like where they'll set up trial sites and what outreach they'll do. Every year, companies must report back on whether they're actually hitting those enrollment targets. If they're falling short, they either need to explain why (like if people are dropping out) or adjust their approach.

If a company gets FDA approval for a drug or device but didn't meet their diversity enrollment targets, the FDA can now require them to conduct additional studies after the product hits the market to gather safety and effectiveness data for the groups that weren't well-represented in the original trials. However, companies can avoid this requirement if they provide a good reason for why they couldn't recruit diverse participants. The bill also funds community health centers and outreach programs to help underrepresented communities learn about and participate in clinical trials, recognizing that barriers like transportation, trust, and access to information have historically kept certain groups out of research.

The practical impact is that future patients—especially those from racial and ethnic minorities, older adults, and other underrepresented groups—should have better information about whether new drugs and devices actually work for them specifically. This could prevent situations where a medication works well for the population that was tested but causes unexpected problems for other groups. The bill gives the FDA three years to write the new rules and requires annual public reports on how well the system is working.

DEPICT Act

Eshoo, Anna G.

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. 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.