RARE Act

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 the same drug for the same approved use or indication with respect to the disease or condition.

Current law grants a seven-year period of market exclusivity for an approved orphan drug, during which the Food and Drug Administration (FDA) may not approve an application from another manufacturer for the same drug for the same disease or condition. The FDA's regulations provide that this exclusivity is specific to the same approved use or indication of the drug, rather than all uses or indications, for the disease or condition. However, in Catalyst Pharmaceuticals, Inc. v. Becerra, a court held that exclusivity did extend to all uses or indications for the disease or condition.

The bill provides statutory authority for the FDA's regulations.

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7383 Introduced in House (IH)]

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118th CONGRESS
  2d Session
                                H. R. 7383

    To amend the Federal Food, Drug, and Cosmetic Act to set forth 
limitations on exclusive approval or licensure of drugs designated for 
                      rare diseases or conditions.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 15, 2024

  Ms. Matsui (for herself and Mr. Bilirakis) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act 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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