S. 4332

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4332 Introduced in Senate (IS)]

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119th CONGRESS
2d Session
S. 4332

To require the Secretary of Health and Human Services to make 
determinations of the exclusivity periods for which licensed biological 
products are eligible.

_______________________________________________________________________

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.''.
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