Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act
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.
This shortened marketing-exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this 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 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 ``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.
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PRICED Act
To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years.
PRICED Act
Price Relief, Innovation, and Competition for Essential Drugs Act
Rep. Schakowsky, Janice D.