H.R. 1223: OPEN Act
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H.R. 1223: OPEN Act
115th Congress · introduced 2017-02-27 · Health · Latest: Referred to the Subcommittee on Health.
federal
Follow this bill, step by step
- Where it came from: introduced 2017-02-27 · official record
- Who proposed it: Rep. Bilirakis, Gus M. [R-FL-12] · 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
OPEN Act
Plain summary
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease). HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement. HHS must notify the public of products that receive this extension and patents related to those products. Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions. The bill applies only to products approved after enactment of this bill for a new indication that is a rare disease or condition.
Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.
What a vote does
A “Yea” vote
If it passes both chambers and is signed, it becomes law.
A “Nay” vote
If it is not passed, current law stays as it is.
PSI Sci description of the legislative step (not an opinion).
What does this mean? (plain words)
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The strongest published arguments
Arguments for (supporters)
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Alternatives
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Rep. Bilirakis, Gus M. [R-FL-12] · 43 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
Michael T. McCaul (R-TX), Darren Soto (D-FL), Donald Norcross (D-NJ), Jared Huffman (D-CA), Don Bacon (R-NE), Daniel Webster (R-FL), Zoe Lofgren (D-CA), Christopher H. Smith (R-NJ), Brian K. Fitzpatrick (R-PA), Bonnie Watson Coleman (D-NJ)
Sponsor's campaign money: Rep. Bilirakis, Gus M. [R-FL-12] reported raising $2.3 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)
- Bill
- 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).
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Introduced in House)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-115hr1223.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/115/hr>
Record fed-us-cong115-hr1223 · catalog fed-us-congress-bills-cong115 · updated 2026-11-15 by psicol fed-bills-cong115