117 HR 7828 IH: Price Relief, Innovation, and Competition for Essential Drugs Act U.S. House of Representatives 2022-05-18 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.

I117th CONGRESS2d SessionH. R. 7828IN THE HOUSE OF REPRESENTATIVESMay 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 CommerceA BILLTo 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.