Biomedical Research Legislation

Gabriella Miller Kids First Research Act 2.0 (S.1624 & H.R.3391)

• The bill would reauthorize the Gabriella Miller Kids First Pediatric Research Program at NIH. Both the House and Senate proposals would move the program from the NIH Common Fund to the NIH Division of Program, Coordination, Planning, and Strategic Initiatives, within the NIH Office of the Director. H.R. 3391 proposes a reauthorization through 2028, and S. 1624 through 2023. The Senate bill proposes an increase in the authorization of appropriations for the program, however it does not identify a designated source of funds. (The initial Gabriella Miller Kids First Research Act, Public Law 113-94, leveraged unspent funds from the Presidential Election Campaign Fund.)

Humane and Existing Alternatives in Research and Testing Sciences (HEARTS) Act (H.R. 1024)

• This bill would direct NIH to provide incentives to researchers to use non-animal methods when feasible and applicable, as well as establish a dedicated center within the NIH devoted to advancing new alternative methods and developing a plan for reducing the use of animals in federally funded research.

NIH Clinical Trial Diversity Act of 2023 (S.1701 & H.R.3503)

• The bill would require NIH to work with clinical trial sponsors to develop clear and measurable recruitment and retention goals based on disease/condition prevalence as well as a rationale for specified goals and a recruitment plan; ensure the availability of less burdensome follow-ups during clinical trials (e.g. fewer follow-ups, phone participation, weekend hours) to increase participation of underrepresented populations; the bill would also direct NIH and FDA to launch a public awareness campaign across federal agencies related to research participation opportunities.

Pediatricians Accelerate Childhood Therapies (PACT) Act of 2023 (S.2345 & H.R. 4714)   

• The legislation would authorize the Director of the NIH to make awards to outstanding scientists, including physician-scientists, to support researchers focusing on pediatric research, including basic, clinical, translational, or pediatric pharmacological research.

Pharmaceutical Research Transparency Act of 2023 (H.R. 3160) 

• The legislation would require the disclosure of costs associated with clinical trials and pharmaceutical research and development. If enacted, NIH must create a publicly available repository of cost data from certain clinical trials that test the efficacy of drugs, biological products, and devices in human subjects.