Advancing Education on Biosimilars Act of 2021
Bill: S.164 | Sponsor: Sen. Hassan, Margaret Wood (D-NH)
Policy area: Health

Summary:
Advancing Education on Biosimilars Act of 2021
This bill requires the Food and Drug Administration (FDA) to advance education and awareness among health care providers about biological products as appropriate, including by developing or improving continuing education programs that address the prescribing of biological products and biosimilars. (A biosimilar is a biological product that is highly similar to an FDA-approved reference biological product and has no clinically meaningful differences from that reference product.)  The FDA may also maintain and operate a website to provide educational materials about biological products.

[117th Congress Public Law 8]
[From the U.S. Government Publishing Office]



[[Page 135 STAT. 254]]

Public Law 117-8
117th Congress

                                 An Act


 
To educate health care providers and the public on biosimilar biological 
 products, and for other purposes. <<NOTE: Apr. 23, 2021 -  [S. 164]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Advancing 
Education on Biosimilars Act of 2021.>> 
SECTION 1. <<NOTE: 42 USC 201 note.>>  SHORT TITLE.

    This Act may be cited as the ``Advancing Education on Biosimilars 
Act of 2021''.
SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS.

    Subpart 1 of part F of title III of the Public Health Service Act 
(42 U.S.C. 262 et seq.) is amended by adding at the end the following:
``SEC. 352A. <<NOTE: 42 USC 263-1.>>  EDUCATION ON BIOLOGICAL 
                          PRODUCTS.

    ``(a) Internet Website.--
            ``(1) In general.--The Secretary may maintain and operate an 
        internet website to provide educational materials for health 
        care providers, patients, and caregivers, regarding the meaning 
        of the terms, and the standards for review and licensing of, 
        biological products, including biosimilar biological products 
        and interchangeable biosimilar biological products.
            ``(2) Content.--Educational materials provided under 
        paragraph (1) may include--
                    ``(A) explanations of key statutory and regulatory 
                terms, including `biosimilar' and `interchangeable', and 
                clarification regarding the use of interchangeable 
                biosimilar biological products;
                    ``(B) information related to development programs 
                for biological products, including biosimilar biological 
                products and interchangeable biosimilar biological 
                products and relevant clinical considerations for 
                prescribers, which may include, as appropriate and 
                applicable, information related to the comparability of 
                such biological products;
                    ``(C) an explanation of the process for reporting 
                adverse events for biological products, including 
                biosimilar biological products and interchangeable 
                biosimilar biological products; and
                    ``(D) an explanation of the relationship between 
                biosimilar biological products and interchangeable 
                biosimilar biological products licensed under section 
                351(k) and reference products (as defined in section 
                351(i)), including the standards for review and 
                licensing of each such type of biological product.

[[Page 135 STAT. 255]]

            ``(3) Format.--The educational materials provided under 
        paragraph (1) may be--
                    ``(A) in formats such as webinars, continuing 
                education modules, videos, fact sheets, infographics, 
                stakeholder toolkits, or other formats as appropriate 
                and applicable; and
                    ``(B) tailored for the unique needs of health care 
                providers, patients, caregivers, and other audiences, as 
                the Secretary determines appropriate.
            ``(4) Other information.--In addition to the information 
        described in paragraph (2), the Secretary shall continue to 
        publish--
                    ``(A) the action package of each biological product 
                licensed under subsection (a) or (k) of section 351; or
                    ``(B) the summary review of each biological product 
                licensed under subsection (a) or (k) of section 351.
            ``(5) Confidential and trade secret information.--This 
        subsection does not authorize the disclosure of any trade 
        secret, confidential commercial or financial information, or 
        other matter described in section 552(b) of title 5.

    ``(b) Continuing Education.--The Secretary shall advance education 
and awareness among health care providers regarding biological products, 
including biosimilar biological products and interchangeable biosimilar 
biological products, as appropriate, including by developing or 
improving continuing education programs that advance the education of 
such providers on the prescribing of, and relevant clinical 
considerations with respect to, biological products, including 
biosimilar biological products and interchangeable biosimilar biological 
products.''.

    Approved April 23, 2021.

LEGISLATIVE HISTORY--S. 164:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 167 (2021):
            Mar. 3, considered and passed Senate.
            Apr. 14, considered and passed House.

                                  <all>