Title: Affordable Insulin Approvals Now Act
Policy area: Health

Summary:
Affordable Insulin Approvals Now ActThis bill requires the continued review and approval, as appropriate, of certain pending applications for generic insulin beyond the March 23, 2020, cutoff date previously established by the Food and Drug Administration. Beginning March 23, 2020, these approved generic insulin drugs also are deemed licensed biological products.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2103 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                S. 2103

                To improve access to affordable insulin.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 11, 2019

  Mr. Durbin (for himself, Mr. Cramer, and Ms. Smith) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
                To improve access to affordable insulin.

    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.''.
                                 <all>