Title: RARE Act
Policy area: Health

Summary:
Retaining Access and Restoring Exclusivity Act or the RARE Act
This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of other drugs for the same approved use or indication with respect to the disease or condition (rather than only with respect to the same disease or condition).

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4185 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4185

       To set forth limitations on exclusivity for orphan drugs.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                 May 11 (legislative day, May 10), 2022

  Ms. Baldwin (for herself and Mr. Cassidy) 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 exclusivity for orphan drugs.

    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 
                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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