PRICED Act

Bill: 116-hr-3379
Sponsor: full_name: Rep. Schakowsky, Janice D. [D-IL-9]
Introduced: 2019-06-20
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Licensing and registrations

Marketing and advertising
Latest action: action_date: 2019-06-21
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2019-06-20
action_desc: Introduced in House
text: <p><b>Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act</b></p> <p>This bill allows biosimilars to be marketed five years after the reference brand-name biological product is licensed. Currently, brand-name biological products are provided a 12-year marketing-exclusivity period.</p> <p>This shortened marketing-exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill. </p>

tv_txt: I 116th CONGRESS 1st Session H. R. 3379 IN THE HOUSE OF REPRESENTATIVES June 20, 2019 Ms. Schakowsky (for herself, Mr. Westerman , Ms. DeLauro , Ms. Craig , Mr. Doggett , Mr. Krishnamoorthi , Mr. Khanna , Mr. Cicilline , Mr. Pocan , Mr. Rush , Mr. Levin of Michigan , Mr. Morelle , Ms. Jayapal , Ms. Tlaib , Ms. Kaptur , Mr. Welch , and Mr. García of Illinois ) 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.