[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3379 Introduced in House (IH)]

<DOC>






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. Garcia 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.

    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.
                                 <all>