Library / Laws / 117th / hr / H.R. 7828 / Introduced in House
I
117th CONGRESS
2d Session
H. R. 7828
IN THE HOUSE OF REPRESENTATIVES
May 18, 2022Ms. Schakowsky (for herself, Mr. Westerman, Mr. Khanna, Mr. Doggett, Mr. Pocan, Ms. Kaptur, Mr. García of Illinois, and Ms. DeLauro) introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years.
1.
Short title
This Act may be cited as the Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act.
2.
Exclusivity period for brand name biological products
(a)
In general
Section 351(k)(7)(A) of the Public Health Service Act (42 U.S.C. 262(k)(7)(A)) is amended by striking 12 years and inserting 5 years.
(b)
Conforming changes
Paragraphs (2)(A) and (3)(A) of section 351(m) of the Public Health Service Act (42 U.S.C. 262(m)) is amended by striking 12 years each place it appears and inserting 5 years.
(c)
Applicability
This Act and the amendments made by this Act apply only with respect to a biological product for which the reference product (as such term is used in section 351 of the Public Health Service Act (42 U.S.C. 262)) is licensed under subsection (a) of such section on or after the date of enactment of this Act.