S. 1681 — what changed

changed This Act may be cited as the “Advancing Education on Biosimilars Act of 2019”.2020”.

added 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:

added “352A. Education on biological products

added “(a) Internet website

added “(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.

added “(2) Content—Educational materials provided under paragraph (1) may include—

added “(A) explanations of key statutory and regulatory terms, including biosimilar and interchangeable, and clarification regarding the use of interchangeable biosimilar biological products;

added “(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;

added “(C) an explanation of the process for reporting adverse events for biological products, including biosimilar biological products and interchangeable biosimilar biological products; and

added “(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.

added “(3) Format—The educational materials provided under paragraph (1) may be—

added “(A) in formats such as webinars, continuing education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and

added “(B) tailored for the unique needs of health care providers, patients, caregivers, and other audiences, as the Secretary determines appropriate.

added “(4) Other information—In addition to the information described in paragraph (2), the Secretary shall continue to publish—

added “(A) the action package of each biological product licensed under subsection (a) or (k) of section 351; or

added “(B) the summary review of each biological product licensed under subsection (a) or (k) of section 351.

added “(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.

added “(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.”

removed “352A. Education on biological products

removed “(a) Internet website

removed “(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.

removed “(2) Format—The educational materials provided under paragraph (1)—

removed “(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;

removed “(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;

removed “(C) shall be tailored for the unique needs of appropriate target audiences, including—

removed “(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

removed “(ii) patients and caregivers; and

removed “(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.

removed “(3) Content—Educational materials provided under paragraph (1) shall include explanations of—

removed “(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;

removed “(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;

removed “(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);

removed “(D) the development program and totality of the evidence required for biosimilar biological product development and how prescribers can evaluate such information;

removed “(E) the process for reporting adverse events for all biological products, including biosimilar and interchangeable biological products;

removed “(F) the relationship between—

removed “(i) variation among biological products licensed under section 351(k) and their reference products licensed under section 351(a); and

removed “(ii) lot-to-lot variability for a biological product licensed under section 351(a) or section 351(k) (including interchangeable biological products);

removed “(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);

removed “(H) whether the role of analytical characterization is novel to biosimilar biological product development; and

removed “(I) how the Food and Drug Administration considers biosimilar biological products to be as safe and effective as their reference products.

removed “(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:

removed “(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.

removed “(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.

removed “(C) The history and timing of manufacturing changes with respect to biological products licensed under section 351(a).

removed “(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.”

removed “(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.”