A drug that stops being an orphan drug starts a new clock
To provide for reconciliation pursuant to title II of H. Con. Res. 14, section 71203, Sec. 71203.
Written by .
A drug that stops being an orphan drug starts a new clock
The document says “shall apply”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 71203 in the PDF
What the document says
“In the case of a drug or biological product that, as of the date of the approval or licensure of such drug or biological product, is a drug or biological product described in paragraph (3)(A)”
The section adds a new paragraph (4) to section 1192(e) of the Social Security Act so that for a drug or biological product that was an orphan drug when approved or licensed, the date used in the negotiation timing rules is the first day after approval or licensure on which it is no longer such a drug. The amendments apply to initial price applicability years beginning on or after January 1, 2028.
What the document actually says
“In the case of a drug or biological product that, as of the date of the approval or licensure of such drug or biological product, is a drug or biological product described in paragraph (3)(A)”
That sentence, in plain words
A drug may count as an orphan drug when first approved. The rule that follows covers such a drug.
What this is about
Its clock starts later than usual. It starts the day it stops being an orphan drug. That pushes back when price talks may reach it.
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Provide for reconciliation pursuant to title II of H. Con. Res. 14, Public Law 119-21, sec. 71203, 139 Stat. 320 (2025). https://www.govinfo.gov/content/pkg/PLAW-119publ21/html/PLAW-119publ21.htm
This page
“A drug that stops being an orphan drug starts a new clock,” Provide for reconciliation pursuant to title II of H. Con. Res. 14, section 71203, Sec. 71203. Read the Mandate, https://readthemandate.org/pl-119-21/proposal/sec71203-former-orphan/ (retrieved October 10, 2026).
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