S. 3716

RARE Act

Shown here: Introduced in Senate (2026-01-28)

To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions.

1. Short title

This Act may be cited as the “Retaining Access and Restoring Exclusivity Act” or the “RARE Act”.

2. Limitations on exclusive approval or licensure of orphan drugs

(a) In general

Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended—

(1) 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”;

(2) in subsection (b)—

(A) in the matter preceding paragraph (1), by 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

(B) in paragraph (1), by inserting “, relating to the approved use or indication,” after “the needs”;

(3) in subsection (c)(1), by 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) by adding at the end the following:

(f) Approved use or indication defined
In this section, the term approved use or indication means the use or indication approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition.

(b) Application of amendments

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 under section 505 of such Act (21 U.S.C. 355) or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262).