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To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions.
Summary
This bill modifies the market exclusivity rules for drugs designated to treat rare diseases or conditions, known as orphan drugs. Currently, when a drug is approved for a rare disease, it receives 7 years of market exclusivity that prevents competitors from getting approval for the same disease or condition. The bill narrows this exclusivity protection to apply only to the specific use or indication for which the drug was approved, rather than the entire disease or condition. This change would allow other companies to develop and obtain approval for different uses or indications within the same rare disease during the 7-year exclusivity period. The bill applies retroactively to all drugs designated for rare diseases regardless of when they were designated or approved.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Sen. Baldwin, Tammy [D-WI] (D-WI)
Actions (2)
- Jan 28, 2026 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · senate
- Jan 28, 2026 Introduced in Senate
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
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). <all>
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