PRICED Act

Bill: 114-hr-5573
Sponsor: full_name: Rep. Schakowsky, Janice D. [D-IL-9]
Introduced: 2016-06-23
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Licensing and registrations

Marketing and advertising
Latest action: action_date: 2016-06-23
text: Referred to the House Committee on Energy and Commerce.

Summaries:
action_date: 2016-06-23
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 amends the Public Health Service Act to allow biosimilars to be marketed seven years after the reference brand name biological product is licensed. Currently, brand name biological products are provided a 12-year marketing exclusivity period.</p> This shortened marketing exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill.

tv_txt: I 114th CONGRESS 2d Session H. R. 5573 IN THE HOUSE OF REPRESENTATIVES June 23, 2016 Ms. Schakowsky (for herself, Mr. Cummings , Mr. McDermott , Mr. Doggett , and Mr. Welch ) 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.