Bill · S. 3716· Senate(119-S-3716)
RARE Act
- Introduced
- 1/28/2026
- Last activity
- 1/28/2026 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Tammy Baldwin
- Cosponsors
- None
- Introduced
- In Committee
What this bill would do
This bill, known as the "Retaining Access and Restoring Exclusivity Act" or the "RARE Act," aims to limit exclusive approval or licensure for drugs used for rare diseases or conditions. It seeks to amend Section 527 of the Federal Food, Drug, and Cosmetic Act. The primary change involves shifting the focus from the "same disease or condition" to the "same approved use or indication." These amendments apply to drugs designated under section 526 regardless of when they were designated or approved.
Yes· 3 of 5
Does this lower the price of prescription medicines?+4
The bill limits exclusivity periods to specific indications, which can facilitate more competition and potentially lower drug prices.
Would people with disabilities be better off under this?+3
Increased competition for rare disease treatments may improve access to various indications for the same condition.
Does this give people more protection from unfair business practices?+3
By narrowing exclusivity to specific indications, the bill may increase competition and lower costs for drugs used for rare diseases.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
- Refined Exclusivity Standards: By changing the criteria from the entire "same disease or condition" to the "same approved use or indication," the bill alters how exclusivity is granted (Section 2(a)(1), 2(a)(2)(A), and 2(a)(3)). This could potentially allow for more competition if a drug is being used for a different purpose within the same rare disease.
Potential Negative Impacts for People
- No specific negative impacts are explicitly stated in the provided text: The text focuses on the technical amendments to the Federal Food, Drug, and Cosmetic Act regarding how "approved use or indication" is defined and applied to exclusivity, but it does not list negative consequences.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For People With Disabilities+3Good For Low Income Households+2Good For Middle Class Households+2
- Healthcare
- Reduces Prescription Drug Costs+4
- Economy And Finance
- Improves Consumer Protection+3
- 1/28/2026
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced in Senate
2 bills Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.