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“ADVANCING EDUCATION ON BIOSIMILARS ACT OF 2021” published by Congressional Record in the Senate section on March 3

Volume 167, No. 40, covering the 1st Session of the 117th Congress (2021 - 2022), was published by the Congressional Record.

The Congressional Record is a unique source of public documentation. It started in 1873, documenting nearly all the major and minor policies being discussed and debated.

“ADVANCING EDUCATION ON BIOSIMILARS ACT OF 2021” mentioning Richard J. Durbin was published in the Senate section on page S1021 on March 3.

Of the 100 senators in 117th Congress, 24 percent were women, and 76 percent were men, according to the Biographical Directory of the United States Congress.

Senators' salaries are historically higher than the median US income.

The publication is reproduced in full below:

ADVANCING EDUCATION ON BIOSIMILARS ACT OF 2021

Mr. DURBIN. Madam President, I ask unanimous consent that the Committee on Health, Education, Labor, and Pensions be discharged from further consideration of S. 164 and the Senate proceed to its immediate consideration.

The PRESIDING OFFICER. The clerk will report the bill by title.

The legislative clerk read as follows:

A bill (S. 164) 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.

Mr. DURBIN. I ask unanimous consent that the bill be considered read a third time and passed and the motion to reconsider be considered made and laid upon the table.

The PRESIDING OFFICER. Without objection, it is so ordered.

The bill (S. 164) was ordered to be engrossed for a third reading, was read the third time, and passed, as follows

S. 164

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 ``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. 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.''.

____________________

SOURCE: Congressional Record Vol. 167, No. 40

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