Bill Sponsor
Senate Bill 1214
118th Congress(2023-2024)
RARE Act
Introduced
Introduced
Introduced in Senate on Apr 19, 2023
Overview
Text
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Bill Sponsor regularly scans bill texts to find sections that are contained in other bill texts. When a matching section is found, the bills containing that section can be viewed by clicking "View Bills" within the bill text section.
Bill Sponsor is currently only finding exact word-for-word section matches. In a future release, partial matches will be included.
S. 1214 (Reported-in-Senate)

Calendar No. 109

118th CONGRESS
1st Session
S. 1214


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


IN THE SENATE OF THE UNITED STATES

April 19, 2023

Ms. Baldwin (for herself and Mr. Braun) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

June 22, 2023

Reported by Mr. Sanders, without amendment


A BILL

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

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

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

SEC. 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).


Calendar No. 109

118th CONGRESS
     1st Session
S. 1214

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

June 22, 2023
Reported without amendment