RARE Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3716 Introduced in Senate (IS)]

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119th CONGRESS
  2d Session
                                S. 3716

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 28, 2026

  Ms. Baldwin introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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).
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