[Congressional Record Volume 165, Number 116 (Thursday, July 11, 2019)]
[Senate]
[Page S4809]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself, Mr. Cramer, and Ms. Smith):
  S. 2103. A bill to improve access to affordable insulin; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. DURBIN. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2103

       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 ``Affordable Insulin Approvals 
     Now Act''.

     SEC. 2. DEEMED APPROVAL UNDER SECTION 351.

       Section 7002(e)(4) of the Biologics Price Competition and 
     Innovation Act of 2009 (Public Law 111-148) is amended--
       (1) by striking ``An amended'' and inserting the following:
       ``(A) In general.--An amended''; and
       (2) by adding at the end the following:
       ``(B) Treatment of certain pending applications.--With 
     respect to an application for an insulin biological product 
     submitted under subsection (b)(2) or (j) of section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) with 
     a filing date that is not later than December 31, 2019, until 
     the Secretary makes a determination on final approval with 
     respect to such application, the Secretary shall continue to 
     review and approve (as appropriate) such application under 
     such section 505, even if such review and approval process 
     continues after March 23, 2020. For purposes of completing 
     the review and approval process for such an application, any 
     listed drug referenced in the application shall be treated as 
     a listed drug under section 505(j)(7) of the Federal Food, 
     Drug, and Cosmetic Act, even if such listed drug is deemed 
     licensed under section 351 of the Public Health Service Act 
     during such review and approval process. Effective on the 
     later of March 23, 2020, or the date of approval under 
     subsection (c) or (j) of section 505 of the Federal Food, 
     Drug, and Cosmetic Act of any such application, such approved 
     application shall be deemed to be a license for the 
     biological product under section 351 of the Public Health 
     Service Act.''.
                                 ______