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119-s-705119th CongressWALLET

Innovation in Pediatric Drugs Act of 2025

Sponsored By: Senator Reed, Jack [D-RI]

Introduced

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.

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  • 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.

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Bill Overview

Analyzed Economic Effects

3 provisions identified: 1 benefits, 0 costs, 2 mixed.

NIH can set aside pediatric funds

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

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 on or after 180 days after enactment. FDA would not enforce against products that are no longer marketed. If enacted, FDA must also list penalties, settlements, and payments for pediatric-study failures in its public report, showing the drug name, sponsor, and amount.

New rules for orphan pediatric studies

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 filed on or after the later of 18 months after final guidance or a later date FDA sets. FDA must publish draft guidance within 1 year, hold a public meeting within 6 months of the draft, and finalize guidance within 18 months after that meeting. If enacted, the Comptroller General would also report within 4 years after the rule starts to study effects on rare disease drug development and pediatric information.

Sponsors & CoSponsors

Sponsor

Reed, Jack [D-RI]

RI • D

Cosponsors

  • Sen. Capito, Shelley Moore [R-WV]

    WV • R

    Sponsored 2/25/2025

Roll Call Votes

No roll call votes available for this bill.

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