Title: Lower Insulin Costs Now Act
Policy area: Health

Summary:
This bill requires the Food and Drug Administration (FDA) to continue to review applications for certain biological products under an earlier review process, notwithstanding recent FDA guidance. (A 2009 law established a new procedure for approving biological products but allowed certain products in an already approved product class to receive approval under the earlier procedure until March 23, 2020; subsequently, in December 2018, the FDA issued guidance stating that an application filed under the earlier procedure that is not approved by March, 23, 2020, will not be approved.)
The bill requires the FDA to continue reviewing an application filed not later than March 23, 2019, under the earlier procedure, even if it was not approved as of March 23, 2020.
Such an application not approved after October 1, 2022, shall be deemed withdrawn.
Such an approved application shall be deemed a biological product license.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5444 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 5444

To amend the Biologics Price Competition and Innovation Act of 2009 to 
 streamline the transition of certain products from approval as a drug 
     to licensure as a biological product, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 17, 2019

 Ms. Underwood (for herself, Ms. Schakowsky, Mr. Guthrie, Mr. Kelly of 
Pennsylvania, and Mr. Levin of Michigan) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Biologics Price Competition and Innovation Act of 2009 to 
 streamline the transition of certain products from approval as a drug 
     to licensure as a biological product, and for other purposes.

    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 ``Lower Insulin Costs Now Act''.

SEC. 2. STREAMLINING THE TRANSITION OF BIOLOGICAL PRODUCTS.

    Section 7002(e)(4) of the Biologics Price Competition and 
Innovation Act of 2009 (Public Law 111-148) is amended--
            (1) by striking ``An approved application'' and inserting 
        the following:
                    ``(A) In general.--An approved application''; and
            (2) by adding at the end the following:
                    ``(B) Treatment of certain applications.--
                            ``(i) In general.--With respect to an 
                        application for a biological product submitted 
                        under subsection (b) or (j) of section 505 of 
                        the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355) that is filed not later than March 
                        23, 2019, and is not approved as of March 23, 
                        2020, the Secretary shall continue to review 
                        such application under such section 505, after 
                        March 23, 2020.
                            ``(ii) Effect on listed drugs.--Only for 
                        purposes of carrying out clause (i), with 
                        respect to any applicable listed drug with 
                        respect to such application, the following 
                        shall apply:
                                    ``(I) Any drug that is a biological 
                                product that has been deemed licensed 
                                under section 351 of the Public Health 
                                Service Act (42 U.S.C. 262) pursuant to 
                                subparagraph (A) and that is referenced 
                                in an application described in clause 
                                (i), shall continue to be identified as 
                                a listed drug on the list published 
                                pursuant to section 505(j)(7) of the 
                                Federal Food, Drug, and Cosmetic Act, 
                                and the information for such drug on 
                                such list shall not be revised after 
                                March 20, 2020, until--
                                            ``(aa) such drug is removed 
                                        from such list in accordance 
                                        with subclause (III) or 
                                        subparagraph (C) of such 
                                        section 505(j)(7); or
                                            ``(bb) this subparagraph no 
                                        longer has force or effect.
                                    ``(II) Any drug that is a 
                                biological product that has been deemed 
                                licensed under section 351 of the 
                                Public Health Service Act (42 U.S.C. 
                                262) pursuant to subparagraph (A) and 
                                that is referenced in an application 
                                described in clause (i) shall be 
                                subject only to requirements applicable 
                                to biological products licensed under 
                                such section.
                                    ``(III) Upon approval under 
                                subsection (c) or (j) of section 505 of 
                                the Federal Food, Drug, and Cosmetic 
                                Act of an application described in 
                                clause (i), the Secretary shall remove 
                                from the list published pursuant to 
                                section 505(j)(7) of the Federal Food, 
                                Drug, and Cosmetic Act any listed drug 
                                that is a biological product that has 
                                been deemed licensed under section 351 
                                of the Public Health Service Act 
                                pursuant to subparagraph (A) and that 
                                is referenced in such approved 
                                application, unless such listed drug is 
                                referenced in one or more additional 
                                applications described in clause (i).
                            ``(iii) Deemed licensure.--Upon approval of 
                        an application described in clause (i), such 
                        approved application shall be deemed to be a 
                        license for the biological product under 
                        section 351 of the Public Health Service Act.
                            ``(iv) Rule of construction.--
                                    ``(I) Application of certain 
                                provisions.--
                                            ``(aa) Patent certification 
                                        or statement.--An application 
                                        described in clause (i) shall 
                                        contain a patent certification 
                                        or statement described in, as 
                                        applicable, section 505(b)(2) 
                                        of the Federal Food, Drug, and 
                                        Cosmetic Act or clauses (vii) 
                                        and (viii) of section 
                                        505(j)(2)(A) of such Act and, 
                                        with respect to any listed drug 
                                        referenced in such application, 
                                        comply with related 
                                        requirements concerning any 
                                        timely filed patent information 
                                        listed pursuant to section 
                                        505(j)(7).
                                            ``(bb) Date of approval.--
                                        The earliest possible date on 
                                        which any pending application 
                                        described in clause (i) may be 
                                        approved shall be determined 
                                        based on--

                                                    ``(AA) the last 
                                                expiration date of any 
                                                applicable period of 
                                                exclusivity that would 
                                                prevent such approval 
                                                and that is described 
                                                in section 
                                                505(c)(3)(E), 
                                                505(j)(5)(B)(iv), 
                                                505(j)(5)(F), 505A, 
                                                505E, or 527 of the 
                                                Federal Food, Drug, and 
                                                Cosmetic Act; and

                                                    ``(BB) if the 
                                                application was 
                                                submitted pursuant to 
                                                section 505(b)(2) of 
                                                the Federal Food, Drug, 
                                                and Cosmetic Act and 
                                                references any listed 
                                                drug, the last 
                                                applicable date 
                                                determined under 
                                                subparagraph (A), (B), 
                                                or (C) of section 
                                                505(c)(3) of such Act, 
                                                or, if the application 
                                                was submitted under 
                                                section 505(j) of such 
                                                Act, the last 
                                                applicable date 
                                                determined under clause 
                                                (i), (ii), or (iii) of 
                                                section 505(j)(5)(B).

                                    ``(II) Exclusivity.--Nothing in 
                                this subparagraph shall be construed to 
                                affect section 351(k)(7)(D) of the 
                                Public Health Service Act.
                            ``(v) Listing.--The Secretary may continue 
                        to review an application after March 23, 2020, 
                        pursuant to clause (i), and continue to 
                        identify any applicable listed drug pursuant to 
                        clause (ii) on the list published pursuant to 
                        section 505(j)(7) of the Federal Food, Drug, 
                        and Cosmetic Act, even if such review or 
                        listing may reveal the existence of such 
                        application and the identity of any listed drug 
                        for which the investigations described in 
                        section 505(b)(1)(A) of the Federal Food, Drug, 
                        and Cosmetic Act are relied upon by the 
                        applicant for approval of the pending 
                        application. Nothing in this subparagraph shall 
                        be construed as authorizing the Secretary to 
                        disclose any other information that is a trade 
                        secret or confidential information described in 
                        section 552(b)(4) of title 5, United States 
                        Code.
                            ``(vi) Sunset.--Beginning on October 1, 
                        2022, this subparagraph shall have no force or 
                        effect and any applications described in clause 
                        (i) that have not been approved shall be deemed 
                        withdrawn.''.
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