Advancing Education on Biosimilars Act of 2020

Bill: 116-s-1681
Sponsor: full_name: Sen. Enzi, Michael B. [R-WY]
Introduced: 2019-05-23
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Government information and archives

Health personnel

Immunology and vaccination

Licensing and registrations

Manufacturing

Medical education

Medicare

Prescription drugs
Latest action: action_date: 2020-12-18
text: Held at the desk.

Summaries:
action_date: 2019-05-23
action_desc: Introduced in Senate
text: <p><b>Advancing Education on Biosimilars Act of 2019</b></p> <p>This bill addresses education for the public and for health care providers regarding biosimilars. (Biosimilars are biological products approved by the Food and Drug Administration based on their similarity to an already approved biological product.)</p> <p>The bill requires the Department of Health and Human Services (HHS) to create a website for educational materials on the meaning and use of biosimilars and interchangeable biological products.</p> <p>HHS must also develop or improve continuing medical education programs for health care providers regarding biosimilars.</p>

action_date: 2020-12-17
action_desc: Passed Senate
text: <p><b>Advancing Education on Biosimilars Act of 20</b><strong>20</strong></p> <p>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.)<br> <br> The FDA may also maintain and operate a website to provide educational materials about biological products.</p>

tv_txt: II 116th CONGRESS 1st Session S. 1681 IN THE SENATE OF THE UNITED STATES May 23 (legislative day, May 22), 2019 Mr. Enzi (for himself and Ms. Hassan ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To educate health care providers and the public on biosimilar biological products, and for other purposes.

1. Short title This Act may be cited as the Advancing Education on Biosimilars Act of 2019 . 2. Education on biological products (a) In general 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: 352A. Education on biological products (a) Internet website (1) In general The Secretary shall establish, maintain, and operate an internet website consisting of educational materials regarding the meaning and use of biosimilar biological products and interchangeable biological products. (2) Format The educational materials provided under paragraph (1)— (A) may be in the form of webinars, continuing medical education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats, as the Secretary determines appropriate; (B) shall be presented in a manner, using simple terminology, that is easily comprehended by appropriate target audiences, including accounting, to the extent practicable, for varying levels of health literacy among patients and caregivers; (C) shall be tailored for the unique needs of appropriate target audiences, including— (i) health care providers with prescribing authority or dispensing authority under applicable State law, including physicians, nurses, nurse practitioners, physician assistants, pharmacists, and pharmacy technicians; and (ii) patients and caregivers; and (D) may, as appropriate, be additionally tailored to health care providers practicing in specialties in which biological products commonly are prescribed or to patient populations to whom biological products commonly are prescribed or administered. (3) Content Educational materials provided under paragraph (1) shall include explanations of— (A) key statutory and regulatory definitions, including the definitions of the terms biosimilar and interchangeable , and clarification that an interchangeable product is not superior in quality to a biosimilar biological product; (B) how the Secretary determines the safety, purity, and potency of biological products that are the subjects of applications under subsections (a) and (k) of section 351; (C) the application of the same quality and manufacturing standards for biological products under 351(a), biosimilar biological products under 351(k), and interchangeable biological products under 351(k)(4); (D) the development program and totality of the evidence required for biosimilar biological product development and how prescribers can evaluate such information; (E) the process for reporting adverse events for all biological products, including biosimilar and interchangeable biological products; (F) the relationship between— (i) variation among biological products licensed under section 351(k) and their reference products licensed under section 351(a); and (ii) lot-to-lot variability for a biological product licensed under section 351(a) or section 351(k) (including interchangeable biological products); (G) how the Food and Drug Administration assesses data regarding the risk of immunogenicity for originator biological products licensed under section 351(a) and biosimilar biological products licensed under section 351(k); (H) whether the role of analytical characterization is novel to biosimilar biological product development; and (I) how the Food and Drug Administration considers biosimilar biological products to be as safe and effective as their reference products. (4) Other information In addition to the information described in paragraph (3), the internet website established under paragraph (1) shall include the following information (with redactions as required by law for trade secret and confidential commercial information), as a single, searchable database: (A) The action package of each biological product licensed under subsection (a) or (k), within 30 days of approval of the application, or, in the case of a biological product licensed before the date of enactment of the Advancing Education on Biosimilars Act of 2019 , not later than 1 year after such date of enactment. (B) The summary review of each biological product licensed under subsection (a) or (k), within 48 hours of approval of the application, or, in the case of a biological product licensed before the date of enactment of the Advancing Education on Biosimilars Act of 2019 , not later than 1 year after such date of enactment. (C) The history and timing of manufacturing changes with respect to biological products licensed under section 351(a). (b) Continuing medical education The Secretary shall advance education and awareness among health care providers regarding biosimilar biological products, including by developing or improving continuing medical education programs that advance the education of such providers on the prescribing of, and relevant clinical considerations with respect to, biosimilar biological products. . (b) Application under the Medicare Merit-Based Incentive Payment System Section 1848(q)(5)(C) of the Social Security Act ( 42 U.S.C. 1395w–4(q)(5)(C) ) is amended by adding at the end the following new clause: (iv) Clinical medical education program on biosimilar biological products Completion of a clinical medical education program developed or improved under section 352A(b) of the Public Health Service Act by a MIPS eligible professional during a performance period shall earn such eligible professional one-half of the highest potential score for the performance category described in paragraph (2)(A)(iii) for such performance period. A MIPS eligible professional may only count the completion of such a program for purposes of such category one time during the eligible professional's lifetime. .

tv_txt: 116th CONGRESS 2d Session S. 1681 IN THE SENATE OF THE UNITED STATES AN ACT To educate health care providers and the public on biosimilar biological products, and for other purposes.

1. Short title This Act may be cited as the Advancing Education on Biosimilars Act of 2020 . 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: 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. .

Passed the Senate December 17, 2020. Secretary