The change reaches drugs designated or approved at any time
What the document says“The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved”
Subsection (b) of section 6605 makes the amendments apply to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act, whatever the date of designation, and whatever the date of approval under section 505 of that Act or licensure under section 351 of the Public Health Service Act.
What the document actually says“The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved”
The changes cover any drug marked for a rare disease. When it was marked does not matter. When it was approved does not matter.
A change that covered only new drugs would take years to bite. This one reaches drugs already on the market.
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.