H.R. 456: Fairness in Orphan Drug Exclusivity Act
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H.R. 456: Fairness in Orphan Drug Exclusivity Act
118th Congress · introduced 2023-01-24 · Health · Latest: Referred to the Subcommittee on Health.
federal
Follow this bill, step by step
- Where it came from: introduced 2023-01-24 · official record
- Who proposed it: Rep. Carter, Earl L. "Buddy" [R-GA-1] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
- If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.
Official title
Fairness in Orphan Drug Exclusivity Act
Plain summary
Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs within its first 12 years of U.S. sales of the drug. When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.
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Official text
Fairness in Orphan Drug Exclusivity Act
Source: Congressional Research Service summary (Introduced in House)
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] · 0 cosponsors
Cost estimate: No cost estimate published yet.
Sponsor's campaign money: Rep. Carter, Earl L. "Buddy" [R-GA-1] reported raising $7.3 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.
No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.
Words on this page, explained (1)
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- A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
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Sources
- Congressional Research Service summary (Introduced in House)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-118hr456.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/118/hr>
Record fed-us-cong118-hr456 · catalog fed-us-congress-bills-cong118 · updated 2026-11-15 by psicol fed-bills-cong118