Exclusivity attaches to the approved use, not the whole disease
Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, section 6605, Sec. 6605.
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Exclusivity attaches to the approved use, not the whole disease
The document says “is amended”Who acts: CongressHow: statuteSec. 6605 in the PDF
What the document says
“in subsection (a), in the matter following paragraph (2), by striking ``same disease or condition'' and inserting ``same approved use or indication within such rare disease or condition'';”
Subsection (a) of section 6605 amends section 527 of the Federal Food, Drug, and Cosmetic Act in three places, replacing references to the same disease or condition with references to the same approved use or indication. It adds a new subsection (f) defining approved use or indication as the use approved under section 505 of that Act, or licensed under section 351 of the Public Health Service Act, for a drug designated for a rare disease or condition.
What the document actually says
“in subsection (a), in the matter following paragraph (2), by striking ``same disease or condition'' and inserting ``same approved use or indication within such rare disease or condition'';”
That sentence, in plain words
Cross out four words about a disease. Write in words about the approved use within that disease.
What this is about
An orphan drug treats a rare disease. Its maker gets seven years with no rival. Tying that to one use, not the whole disease, leaves room for others.
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Consolidated Appropriations Act, 2026, Public Law 119-75, sec. 6605, 140 Stat. 701 (2026). https://www.govinfo.gov/content/pkg/PLAW-119publ75/html/PLAW-119publ75.htm
This page
“Exclusivity attaches to the approved use, not the whole disease,” Consolidated Appropriations Act, 2026, section 6605, Sec. 6605. Read the Mandate, https://readthemandate.org/consolidated-appropriations-act-2026/proposal/sec6605-narrowed-to-approved-use/ (retrieved October 10, 2026).
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