118 S1214 RS: Retaining Access and Restoring Exclusivity Act U.S. Senate 2023-04-19 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

IICalendar No. 109118th CONGRESS1st SessionS. 1214IN THE SENATE OF THE UNITED STATESApril 19, 2023Ms. Baldwin (for herself and Mr. Braun) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsJune 22, 2023Reported by Mr. Sanders, without amendmentA BILLTo 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).

June 22, 2023Reported without amendment