The carve-out reaches a drug for more than one rare disease
What the document says“by striking "only one rare disease or condition" and inserting "one or more rare diseases or conditions"; and”
The section amends section 1192(e)(3)(A) of the Social Security Act (42 U.S.C. 1320f-1(e)) by replacing only one rare disease or condition with one or more rare diseases or conditions, and by tying the term to the meaning in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act.
What the document actually says“by striking "only one rare disease or condition" and inserting "one or more rare diseases or conditions"; and”
Words limiting the rule to one rare disease are taken out. Words covering one or more are put in.
So a drug for several rare diseases now counts. The meaning of the term comes from a food and drug law. That law is not indexed here.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.