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To require the Secretary of Health and Human Services to make determinations of the exclusivity periods for which licensed biological products are eligible.
Summary
This bill requires the Secretary of Health and Human Services to determine and publicly disclose the exclusivity periods for biological products licensed under the Public Health Service Act. For new biological products licensed after the bill's enactment, the Secretary must publish the expiration dates of exclusivity periods within 30 days after the date can be determined. For biological products licensed before the bill's enactment, the Secretary must publish exclusivity expiration dates within 2 years of the bill's enactment. The bill applies to both reference biological products and interchangeable biological products. This requirement aims to increase transparency regarding when competing biological products can enter the market.
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)
1 cosponsor
- Sen. Budd, Ted [R-NC] (R-NC)
Actions (2)
- Apr 16, 2026 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · senate
- Apr 16, 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
April 16 (legislative day, April 14), 2026
Ms. Hassan (for herself and Mr. Budd) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
A BILL
To require the Secretary of Health and Human Services to make determinations of the exclusivity periods for which licensed biological products are eligible.
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 “Medication Competition Act”.
SEC. 2. DETERMINATION OF REFERENCE PRODUCT EXCLUSIVITY.
Section 351(k)(9)(A)(iv) of the Public Health Service Act (42 U.S.C. 262(k)(9)(A)(iv)) is amended—
(1) by inserting “determine any applicable exclusivity period under paragraph (6) or (7), and shall” after “the Secretary shall”;
(2) by striking the period at the end and inserting “, as follows:”; and
(3) by adding at the end the following:
“(I) Exclusivity for first interchangeable biological products.— “(aa) Products licensed on or after the date of enactment.—With respect to a biological product licensed under this subsection on or after the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph any applicable exclusivity period under paragraph (6), not later than 30 days after the earliest date on which an expiration date of such an exclusivity period can be known pursuant to paragraph
(6). “(bb) Products licensed before the date of enactment.— With respect to a biological product licensed under this subsection before the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph any applicable exclusivity period under paragraph (6), not later than 30 days after the later of such date of enactment or the earliest date on which an expiration date of such an exclusivity period can be known pursuant to paragraph (6).
“(II) Exclusivity for reference products.— “(aa) Products licensed on or after the date of enactment.—With respect to a biological product licensed under subsection (a) on or after the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph the expiration date of any exclusivity period under paragraph (7), not later than 30 days after licensure of the biological product. “(bb) Products licensed before the date of enactment.— With respect to any biological product licensed under subsection (a) before the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph the expiration date of any exclusivity period under paragraph (7), not later than 2 years after such date of enactment.”. <all>
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