Text: S.3094 — 114th Congress (2015-2016)All Information (Except Text)

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Introduced in Senate (06/23/2016)


114th CONGRESS
2d Session
S. 3094


To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.


IN THE SENATE OF THE UNITED STATES

June 23, 2016

Mr. Brown (for himself and Mr. McCain) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions


A BILL

To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

This Act may be cited as the “Price Relief, Innovation, and Competition for Essential Drugs Act” or the “PRICED Act”.

SEC. 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.