[Congressional Record Volume 165, Number 168 (Wednesday, October 23, 2019)]
[Senate]
[Page S6128]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 1028. Mr. DURBIN (for himself, Mr. Cramer, and Ms. Smith) 
submitted an amendment intended to be proposed to amendment SA 948 
proposed by Mr. Shelby to the bill H.R. 3055, making appropriations for 
the Departments of Commerce and Justice, Science, and Related Agencies 
for the fiscal year ending September 30, 2020, and for other purposes; 
which was ordered to lie on the table; as follows:

       At the appropriate place in title VII of division B, insert 
     the following:
       Sec. __.  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.''.
                                 ______