[Congressional Record Volume 166, Number 214 (Thursday, December 17, 2020)]
[Senate]
[Pages S7642-S7643]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             ADVANCING EDUCATION ON BIOSIMILARS ACT OF 2019

  Mr. BRAUN. Mr. President, I ask unanimous consent that the Committee 
on Health, Education, Labor, and Pensions be discharged from further 
consideration of S. 1681 and the Senate proceed to its immediate 
consideration.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The senior assistant legislative clerk read as follows:

       A bill (S. 1681) to educate health care providers and the 
     public on biosimilar biological products, and for other 
     purposes.

  There being no objection, the committee was discharged, and the 
Senate proceeded to consider the bill.

[[Page S7643]]

  

  Mr. BRAUN. I ask unanimous consent that the Alexander substitute 
amendment at the desk be agreed to that the bill, as amended, be 
considered read a third time and passed; and that the motion to 
reconsider be considered made and laid upon the table.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 2716) in the nature of a substitute was agreed to, 
as follows

                (Purpose: In the nature of a substitute)

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Advancing Education on 
     Biosimilars Act of 2020''.

     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. 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.
       ``(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.''.

  The bill (S. 1681), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.

                          ____________________