“A bill to set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions.”
No CRS summary available for this bill.
This section revises orphan drug exclusivity provisions to limit the seven-year period of exclusive FDA approval or licensure (i.e., market exclusivity preventing approval of a competing drug) to the same approved use or indication within a rare disease or condition, rather than the entire rare disease or condition, by making the following changes to section 527 of the Federal Food, Drug, and Cosmetic Act: (1) in subsection (a), striking "same disease or condition" and inserting "same approved use or indication within such rare disease or condition"; (2) in subsection (b), striking "same rare disease or condition" and inserting "same approved use or indication for which such 7-year period applies to such already approved or licensed drug," and inserting ", relating to the approved use or indication," after "the needs"; (3) in subsection (c)(1), striking "same rare disease or condition as the already approved drug" and inserting "same use or indication for which the already approved or licensed drug was approved or licensed"; and (4) adding subsection (f) to define "approved use or indication." The amendments apply retroactively to all drugs designated as orphan drugs under section 526, regardless of designation or approval/licensure date. (Thus, FDA may approve a second orphan drug for a different use or indication within the same rare disease or condition during the first drug's exclusivity period.)