Amendment · S.Amdt. 2617· Senate(119-SAMDT-2617)
S.Amdt. 2617
- Introduced
- 6/29/2025
- Sponsored by
- John Barrasso
- Cosponsors
- None
- Changes bill
- 119-HR-1 — One Big Beautiful Bill Act
- Introduced
- Pending Consideration
- Failed
What this amendment would do
As your legislative analyst, let us break down what Mr. Barrasso's amendment (SA 2617) actually does in plain English. The purpose of this amendment is to expand and clarify the rules for orphan drugs under the drug price negotiation program by changing how time is calculated and how rare diseases are treated.
Here is what the amendment changes and adds to the bill:
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It states that when calculating the amount of time that has elapsed regarding the approval of a drug or biological product, the Secretary must not take into account any period during which the drug or product was designated as a certain type of orphan drug.
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It changes the requirement from "only one rare disease or condition" to "one or more rare diseases or conditions".
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It adds a specific reference to the Federal Food, Drug, and Cosmetic Act to define what one or more rare diseases or conditions means.
- 6/29/2025
- Senate amendment submitted
This bill has no cosponsors