Exclusivity attaches to the approved use, not the whole disease
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'';”
Cross out four words about a disease. Write in words about the approved use within that disease.
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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