S. 4332

119 S4332 IS: Medication Competition Act
 U.S. Senate
 2026-04-16
 text/xml
 EN
 Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
 II  119th CONGRESS  2d Session  S. 4332  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.
1.
Short title
This Act may be cited as the   Medication Competition Act  .
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.
   .