[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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