S. 3716Senate119th Congress (2025-2027)In Committee

RARE Act

AI-Generated Summary

Updated February 19, 2026 at 3:59 AM UTC

The RARE Act (Retaining Access and Restoring Exclusivity Act) changes how the federal law treats exclusive approval or licensing for orphan drugs—drugs for rare diseases. It narrows the scope of exclusivity so that it applies only when a new drug is seeking the same approved use or indication as an existing orphan drug, rather than any drug for the same rare disease. This affects pharmaceutical companies seeking market exclusivity for orphan drugs and the patients who rely on those medicines.

Key Provisions

Amends the FD&C Act to replace language referring to "same disease or condition" with "same approved use or indication within such rare disease or condition" for orphan drug exclusivity.
Updates related sections to require that exclusivity applies only when the new drug targets the same approved use or indication as an already approved or licensed orphan drug.
Adds a definition of "approved use or indication" that ties it to specific FDA approval (section 505) or licensing (section 351) for a drug designated for a rare disease.
Specifies that these changes apply to any drug designated as an orphan drug, regardless of when it was designated or approved.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 28, 2026

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SenateIntro Referral

Introduced in Senate

January 28, 2026

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 28, 2026

Bill Text

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Introduced in SenateIssued January 28, 2026

119th CONGRESS

2d Session

S. 3716

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.

Short title

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

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).