Title: Biologics Market Transparency Act of 2022
Policy area: Health

Summary:
Biologics Market Transparency Act of 2022
This bill requires biologics manufacturers to notify the Food and Drug Administration in advance of withdrawing a product from sale.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4302 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4302

  To amend the Federal Food, Drug, and Cosmetic Act to require prompt 
  reports of marketing status by holders of approved applications for 
              biological products, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 25, 2022

  Mr. Kaine (for himself, Mr. Marshall, Ms. Hassan, and Mr. Cassidy) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to require prompt 
  reports of marketing status by holders of approved applications for 
              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. SHORT TITLE.

    This Act may be cited as the ``Biologics Market Transparency Act of 
2022''.

SEC. 2. PROMPT REPORTS OF MARKETING STATUS BY HOLDERS OF APPROVED 
              APPLICATIONS FOR BIOLOGICAL PRODUCTS.

    (a) In General.--Section 506I of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356i) is amended--
            (1) in subsection (a)--
                    (A) by striking ``The holder of an application 
                approved under subsection (c) or (j) of section 505'' 
                and inserting ``The holder of an application approved 
                under subsection (c) or (j) of section 505 of this Act 
                or subsection (a) or (k) of section 351 of the Public 
                Health Service Act'';
                    (B) in paragraph (2), by inserting ``(or, in the 
                case of a biological product, the proper name)'' after 
                ``established name''; and
                    (C) in paragraph (3), by striking ``or abbreviated 
                application number'' and inserting ``, abbreviated 
                application number, or biologics license application 
                number''; and
            (2) in subsection (b)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``The holder of an application approved under 
                subsection (c) or (j)'' and inserting ``The holder of 
                an application approved under subsection (c) or (j) of 
                section 505 of this Act or subsection (a) or (k) of 
                section 351 of the Public Health Service Act'';
                    (B) in paragraph (1), by inserting ``(or, in the 
                case of a biological product, the proper name)'' after 
                ``established name''; and
                    (C) in paragraph (2), by striking ``or abbreviated 
                application number'' and inserting ``, abbreviated 
                application number, or biologics license application 
                number''.
    (b) Additional One-Time Report.--Subsection (c) of section 506I of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended to 
read as follows:
    ``(c) Additional One-Time Report.--Within 180 days of the date of 
enactment of the Biologics Market Transparency Act of 2022, all holders 
of applications approved under subsection (a) or (k) of section 351 of 
the Public Health Service Act shall review the information in the list 
published under section 351(k)(9)(A) and shall submit a written notice 
to the Secretary--
            ``(1) stating that all of the application holder's 
        biological products in the list published under section 
        351(k)(9)(A) that are not listed as discontinued are available 
        for sale; or
            ``(2) including the information required pursuant to 
        subsection (a) or (b), as applicable, for each of the 
        application holder's biological products that are in the list 
        published under section 351(k)(9)(A) and not listed as 
        discontinued, but have been discontinued from sale or never 
        have been available for sale.''.
    (c) Purple Book.--Section 506I of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356i) is amended--
            (1) in subsection (d)--
                    (A) by striking ``or (c), the Secretary'' and 
                inserting the following: ``or (c)--
            ``(1) the Secretary'';
                    (B) by striking the period at the end and inserting 
                ``; and''; and
                    (C) by adding at the end the following:
            ``(2) the Secretary may identify the application holder's 
        biological products as discontinued in the list published under 
        section 351(k)(9)(A) of the Public Health Service Act, except 
        that the Secretary shall remove from the list, in accordance 
        with section 351(k)(9)(B) of such Act, any biological product 
        for which the license has been revoked or suspended for reasons 
        of safety, purity, or potency.''; and
            (2) in subsection (e)--
                    (A) by inserting after the first sentence the 
                following: ``The Secretary shall update the list 
                published under section 351(k)(9)(A) of the Public 
                Health Service Act based on information provided under 
                subsections (a), (b), and (c) by identifying as 
                discontinued biological products that are not available 
                for sale, except that any biological product for which 
                the license has been revoked or suspended for reasons 
                of safety, purity, or potency shall be removed from the 
                list in accordance with section 351(k)(9)(B) of the 
                Public Health Service Act.''; and
                    (B) in the last sentence--
                            (i) by striking ``updates to the list'' and 
                        inserting ``updates to the lists published 
                        under section 505(j)(7)(A) of this Act and 
                        section 351(k)(9)(A) of the Public Health 
                        Service Act''; and
                            (ii) by striking ``update the list'' and 
                        inserting ``update such lists''.
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