S. 1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
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S. 1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
115th Congress · introduced 2017-06-29 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
federal
Follow this bill, step by step
- Where it came from: introduced 2017-06-29 · official record
- Who proposed it: Sen. Hatch, Orrin G. [R-UT] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
Plain summary
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product 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). The FDA may revoke an extension if the application for the new indication contained an untrue material statement. The FDA must notify the public of products that receive this extension and patents related to those products. Products may receive only one of these extensions. This extension is in addition to other extensions. Only products approved after enactment of this bill for a new indication that is a rare disease or condition are eligible for an extension. For a medication to be approved as an orphan drug with seven years of marketing exclusivity when it is the same medication for the same condition as an already approved orphan drug, the sponsor of the new medication must demonstrate that the new medication is clinically superior to the approved medication. The bill expands to cover brand name drugs provisions that allow generic drugs to be approved and marketed without labeling for pediatric indications when the pediatric indications are protected by patent or marketing exclusivity.
Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.
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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.
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What does this mean? (plain words)
Official text
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
Source: Congressional Research Service summary (Introduced in Senate)
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Alternatives
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Sen. Hatch, Orrin G. [R-UT] · 5 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
Tim Scott (R-SC)
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 Senate)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-115s1509.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/115/s>
Record fed-us-cong115-s1509 · catalog fed-us-congress-bills-cong115 · updated 2026-11-15 by psicol fed-bills-cong115