# 119-s-3716: RARE Act

119-s-3716, RARE Act, is a 119th Congress bill sponsored by Sen. Baldwin, Tammy [D-WI] (D-WI); status introduced; PRIA reads it as touching household money (as of 2026-04-21).

- Canonical: https://policyrisk.com/legislation/119-s-3716
- As of: 2026-04-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-3716
- Congress: 119
- Title: RARE Act
- Status: introduced
- Introduced: 2026-01-28
- Sponsor: Sen. Baldwin, Tammy [D-WI] (D-WI)
- Cosponsors: 0
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-04-21

## Summary

**Limits orphan-drug exclusivity to the drug's approved use or indication.** The bill narrows the scope of the 7-year exclusivity for drugs designated for rare diseases by tying protection to a specific approved use or indication instead of the broader disease, and it applies that rule to all drugs designated under section 526 regardless of when they were designated or approved. - Manufacturers of drugs designated under section 526: Their existing 7-year exclusivity now covers the specific approved use or indication for which the drug was approved or licensed, not the entire rare disease or condition. - Developers of follow-on products: Companies seeking approval for a different use or indication within the same rare disease face a narrower exclusivity barrier than under a disease-wide rule. - Regulatory effect: The bill does not change the length of the exclusivity or how exclusivity is triggered, but it changes the comparison from the "same disease or condition" to the "same approved use or indication."

## Provisions PRIA read

- Narrower orphan drug exclusivity for patients: benefit, low. If enacted, this bill would narrow FDA orphan-drug exclusivity. It would keep the 7-year exclusivity period. Exclusivity would apply only to the same approved use or indication, not to the broader rare disease. The bill would narrow the unmet-need test so it focuses only on needs related to that ap…

## Related bills

- 119-s-524: Coast Guard Authorization Act of 2025
- 119-s-1541: SHIPS for America Act of 2025
- 119-s-5283: Momnibus Act
- 119-s-3597: National Quantum Initiative Reauthorization Act of 2026
- 119-s-3990: PrEP Access and Coverage Act of 2026
- 119-s-2823: FAMILY Act

## Sources
- [119-s-3716 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/3716)

## Related
- [119-s-524: Coast Guard Authorization Act of 2025](https://policyrisk.com/legislation/119-s-524)
- [119-s-1541: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-s-1541)
- [119-s-5283: Momnibus Act](https://policyrisk.com/legislation/119-s-5283)
- [119-s-3597: National Quantum Initiative Reauthorization Act of 2026](https://policyrisk.com/legislation/119-s-3597)
- [119-s-3990: PrEP Access and Coverage Act of 2026](https://policyrisk.com/legislation/119-s-3990)
- [119-s-2823: FAMILY Act](https://policyrisk.com/legislation/119-s-2823)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-3716 (as of 2026-04-21).