Biologics Market Transparency Act of 2022
Bill: H.R.7035 | Sponsor: Rep. Manning, Kathy E. (D-NC)
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.

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''; and
                    (B) 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) 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''; and
                    (B) 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 withdrawn from sale or never have 
        been available for sale.''.
    (c) Purple Book.--Subsections (d) and (e) of section 506I of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) are each 
amended--
            (1) by striking ``the list published under subsection 
        505(j)(7)(A)'' and inserting ``the list published under section 
        505(j)(7)(A) of this Act or section 351(k)(9)(A) of the Public 
        Health Service Act, as applicable,''; and
            (2) by striking ``in accordance with subsection 
        505(j)(7)(C)'' and inserting ``in accordance with section 
        505(j)(7)(C) of this Act or section 351(k)(9)(B) of the Public 
        Health Service Act (as applicable)''.
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