H.R. 5182: Promoting Life-Saving New Therapies for Neonates Act of 2016

114th Congress · introduced 2016-05-10 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

Where it came from: introduced 2016-05-10 · official record
Who proposed it: Rep. Long, Billy [R-MO-7] · 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.

What does this mean?

Official title

Promoting Life-Saving New Therapies for Neonates Act of 2016

Plain summary

Promoting Life-Saving New Therapies for Neonates Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to award the sponsor of a new drug or biological product for the treatment of newborns a neonatal drug exclusivity voucher upon approval of the medication. A neonatal drug exclusivity voucher is a transferable voucher for a one-year extension of all existing patents and marketing exclusivities for a brand name medication. For a sponsor to be eligible for a voucher, the new medication must: (1) treat a condition identified in the Priority List of Critical Needs for Neonates required under this bill, and (2) have been studied in newborns. A voucher may be revoked if the new medication is not marketed in the United States within one year of approval. A voucher may not be used: (1) to extend the marketing exclusivity period for a drug for which the FDA requires an assessment of the safety and effectiveness in newborns, or (2) on the same product as a priority review voucher. A sponsor intending to use a voucher must notify the FDA at least 15 months before the expiration of the patents or exclusivity to be extended. The Government Accountability Office must study the effectiveness of this voucher program.

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.

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What does this mean? (plain words)

Official text

Promoting Life-Saving New Therapies for Neonates Act of 2016

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. Long, Billy [R-MO-7] · 33 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Ben Ray Luján (D-NM), Alma S. Adams (D-NC), Marc A. Veasey (D-TX), Ruben Gallego (D-AZ), Donald Norcross (D-NJ), Brett Guthrie (R-KY), Pete Aguilar (D-CA), Seth Moulton (D-MA), Gus M. Bilirakis (R-FL), Mike Kelly (R-PA), Scott H. Peters (D-CA)

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-114hr5182.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>

Record fed-us-cong114-hr5182 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114