# 119-s-705: Innovation in Pediatric Drugs Act of 2025

119-s-705, Innovation in Pediatric Drugs Act of 2025, is a 119th Congress bill sponsored by Sen. Reed, Jack [D-RI] (D-RI); status introduced; PRIA reads it as touching household money (as of 2025-12-21).

- Canonical: https://policyrisk.com/legislation/119-s-705
- As of: 2025-12-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-705
- Congress: 119
- Title: Innovation in Pediatric Drugs Act of 2025
- Status: introduced
- Introduced: 2025-02-25
- Sponsor: Sen. Reed, Jack [D-RI] (D-RI)
- Cosponsors: 1
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2025-12-21

## Summary

**Advance pediatric drug development** by tightening when and how companies would study drugs in children, increasing transparency on penalties, and creating a focused NIH funding stream for pediatric and molecularly targeted cancer drugs. - Families and children would get clearer expectations and potentially more pediatric information for rare diseases because the bill clarifies when pediatric study rules apply to orphan indications and requires guidance and a GAO study within four years. - Drug sponsors would face a formal noncompliance letter with a required 45-day response window. The bill also adds public reporting of penalties and limits enforcement for drugs no longer marketed, with a 180-day transition rule for enforcement. - Researchers and NIH would gain a small, dedicated stream of support because up to 1% of pediatric research funds could be designated for this program from fiscal years 2026 through 2030. The bill also protects investigations of molecularly targeted pediatric cancer drugs with orphan status and requires draft and final guidance plus a public meeting.

## Cosponsors (1)

- Sen. Capito, Shelley Moore [R-WV] (R-WV), 2025-02-25T00:00:00.000Z

## Provisions PRIA read

- NIH can set aside pediatric funds: benefit, low. If enacted, the NIH director could make up to 1% of each institute's pediatric research funds available for this pediatric research program in fiscal years 2026 through 2030. This only authorizes NIH to reallocate existing pediatric research money. It does not itself appropriate new dollars.
- New FDA enforcement steps and penalties: mixed, low. If enacted, FDA would have to send a formal noncompliance letter and give sponsors 45 days to reply before concluding a failure to do required pediatric studies. FDA would review the reply to see if the sponsor showed lack of due diligence. Enforcement actions could only cover failures that occur o…
- New rules for orphan pediatric studies: mixed, low. If enacted, the bill would change when and how FDA requires pediatric studies for orphan drug uses. FDA would generally not require pediatric assessments for an orphan indication unless it finds a meaningful therapeutic benefit. Sponsors would see a delay: the new rules apply only to applications f…

## Related bills

- 119-s-4949: Water Resources Development Act of 2026
- 119-s-1748: Kids Online Safety Act
- 119-s-1541: SHIPS for America Act of 2025
- 119-s-3990: PrEP Access and Coverage Act of 2026
- 119-s-2287: Palliative Care and Hospice Education and Training Act
- 119-s-5025: Lindsey O. Graham Sanctioning Russia Act of 2026

## Sources
- [119-s-705 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/705)

## Related
- [119-s-4949: Water Resources Development Act of 2026](https://policyrisk.com/legislation/119-s-4949)
- [119-s-1748: Kids Online Safety Act](https://policyrisk.com/legislation/119-s-1748)
- [119-s-1541: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-s-1541)
- [119-s-3990: PrEP Access and Coverage Act of 2026](https://policyrisk.com/legislation/119-s-3990)
- [119-s-2287: Palliative Care and Hospice Education and Training Act](https://policyrisk.com/legislation/119-s-2287)
- [119-s-5025: Lindsey O. Graham Sanctioning Russia Act of 2026](https://policyrisk.com/legislation/119-s-5025)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-705 (as of 2025-12-21).