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116TH CONGRESS
1ST SESSION H. R. 3379
To amend the Public Health Service Act to shorten the exclusivity period
for brand name biological products from 12 to 5 years.
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. GARCI´A of Illinois) intro-
duced 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.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Price Relief, Innova-
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tion, and Competition for Essential Drugs Act’’ or the
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‘‘PRICED Act’’.
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•HR 3379 IH
SEC. 2. EXCLUSIVITY PERIOD FOR BRAND NAME BIOLOGI-
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CAL PRODUCTS.
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(a) IN GENERAL.—Section 351(k)(7)(A) of the Pub-
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lic Health Service Act (42 U.S.C. 262(k)(7)(A)) is amend-
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ed by striking ‘‘12 years’’ and inserting ‘‘5 years’’.
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(b) CONFORMING CHANGES.—Paragraphs (2)(A) and
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(3)(A) of section 351(m) of the Public Health Service Act
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(42 U.S.C. 262(m)) is amended by striking ‘‘12 years’’
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each place it appears and inserting ‘‘5 years’’.
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(c) APPLICABILITY.—This Act and the amendments
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made by this Act apply only with respect to a biological
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product for which the reference product (as such term is
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used in section 351 of the Public Health Service Act (42
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U.S.C. 262)) is licensed under subsection (a) of such sec-
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tion on or after the date of enactment of this Act.
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Æ
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