Title: To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes.
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. Specifically, the bill applies to applications that were filed under the earlier process on or before March 23, 2019, and were still pending on March 23, 2020. (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.)

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6155 Introduced in House (IH)]

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116th CONGRESS
  2d Session
                                H. R. 6155

To amend the Biologics Price Competition and Innovation Act of 2009 to 
    make improvements with respect to the transition of biological 
                   products, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 9, 2020

 Mr. Grothman 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 
    make improvements with respect to the transition of biological 
                   products, 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. STREAMLINING THE TRANSITION OF BIOLOGICAL PRODUCTS.

    (a) Continued Review of Certain Applications.--Section 
7002(e)(4)(B) of the Biologics Price Competition and Innovation Act of 
2009 (Public Law 111-148) is amended--
            (1) by striking clauses (i), (ii), and (vi); and
            (2) by inserting before clause (iii) the following:
                            ``(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 that is pending (or tentatively 
                        approved) as of March 23, 2020--
                                    ``(I) the Secretary shall continue 
                                to review such application under such 
                                section 505, even if such review 
                                continues after March 23, 2020; and
                                    ``(II) upon approval of such 
                                application, such application shall be 
                                deemed to be a license for the 
                                biological product under section 351 of 
                                the Public Health Service Act, pursuant 
                                to subparagraph (A), and any period of 
                                exclusivity, as applicable, shall be 
                                determined in accordance with such 
                                section.
                            ``(ii) Treatment of listed drugs.--With 
                        respect to a 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), such drug shall--
                                    ``(I) 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 (or 
                                removed) unless and until the date on 
                                which each application described in 
                                clause (i) that references such drug 
                                is--
                                            ``(aa) no longer pending 
                                        review (or the approval of such 
                                        drug is tentative) under 
                                        section 505 of the Federal 
                                        Food, Drug, and Cosmetic Act 
                                        (21 U.S.C. 355); or
                                            ``(bb) removed from such 
                                        list in accordance with 
                                        subparagraph (C) of such 
                                        section 505(j)(7);
                                    ``(II) be subject only to 
                                requirements applicable to biological 
                                products licensed under section 351 of 
                                the Public Health Service Act (42 
                                U.S.C. 262); and
                                    ``(III) be deemed to be a reference 
                                product under such section 351 on the 
                                date on which the last application 
                                described in clause (i) that references 
                                such drug is no longer pending review 
                                (or tentatively approved) under section 
                                505 of the Federal Food, Drug, and 
                                Cosmetic Act (21 U.S.C. 355).''.
    (b) Certain Insulin Products Deemed Interchangeable Biosimilars.--
Section 7002(e)(4) of the Biologics Price Competition and Innovation 
Act of 2009 (Public Law 111-148) is amended by adding at the end the 
following:
                    ``(C) Certain insulin products deemed 
                interchangeable biosimilars.--
                            ``(i) In general.--In carrying out 
                        subparagraph (A), a covered insulin product 
                        shall be deemed to be an interchangeable 
                        biosimilar biological product licensed under 
                        section 351(k) of the Public Health Service 
                        Act.
                            ``(ii) Definitions.--In this subparagraph:
                                    ``(I) The terms `biosimilar' and 
                                `interchangeable' have the meaning 
                                given such terms in section 351(i) of 
                                the Public Health Service Act.
                                    ``(II) The term `covered insulin 
                                product' means a biological product 
                                (including a chemically synthesized 
                                polypeptide) that is--
                                            ``(aa) an insulin product; 
                                        and
                                            ``(bb) approved under 
                                        section 505 of the Federal 
                                        Food, Drug, and Cosmetic Act 
                                        pursuant to an application 
                                        submitted under subsection 
                                        (b)(2) of such section.''.
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