On the recordJuly 11, 2019
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.…





