A Democratic bill with no cosponsors
Last activity — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
In committee
Introduced and handed to a committee in the chamber it started in.
The committee holds it, and most bills are never heard from again. A hearing or a committee vote would be news; silence is the usual outcome, and it kills the bill without anyone voting against it.
Its path through Congress
- 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
- Scored +4
Does this lower the price of prescription medicines?
The bill limits exclusivity periods to specific indications, which can facilitate more competition and potentially lower drug prices.
- Scored +3
Would people with disabilities be better off under this?
Increased competition for rare disease treatments may improve access to various indications for the same condition.
- Scored +3
Does this give people more protection from unfair business practices?
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. Tap or hover a score for the reason it gave.
- Demographic And Interest Groups
- Would people with disabilities be better off under this? — Increased competition for rare disease treatments may improve access to various indications for the same condition. Would households on low incomes be better off under this? — Increased drug competition may lead to lower costs for essential medications used for rare diseases. Would middle-income households be better off under this? — Lower medication costs through increased competition could reduce household healthcare spending.
- Healthcare
- Does this lower the price of prescription medicines? — The bill limits exclusivity periods to specific indications, which can facilitate more competition and potentially lower drug prices.
- Economy And Finance
- Does this give people more protection from unfair business practices? — By narrowing exclusivity to specific indications, the bill may increase competition and lower costs for drugs used for rare diseases.
- 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.