I 115th CONGRESS 2d Session H. R. 6577 IN THE HOUSE OF REPRESENTATIVES July 26, 2018 Ms. Schakowsky 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 7 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 7 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 7 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.