S 1681 — Advancing Education on Biosimilars Act of 2020

1681 IntroducedEngrossed in Senate (IS)](ES)] <DOC> 116th CONGRESS 1st2d Session S.

1681 _______________________________________________________________________ AN ACT To educate health care providers and the public on biosimilar biological products, and for other purposes.

_______________________________________________________________________ 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.

This Act may be cited as the ``Advancing Education on Biosimilars Act of 2019''.2020''.

(a)Subpart In General.--Subpart 1 of part F of title III of the Public Health Service Act (42 U.S.C.

``(a) Internet Website.-- ``(1) In general.--The Secretary shallmay establish,maintain maintain, and operate an internet website consistingto ofprovide educational materials for health care providers, patients, and caregivers, regarding the meaning of the terms, and usethe ofstandards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

``(2) Format.--TheContent.--Educational educational materials provided under paragraph (1)--(1) ``(A) may beinclude-- in``(A) theexplanations form of webinars,key continuingstatutory medicaland educationregulatory modules,terms, videos,including fact`biosimilar' sheets,and infographics,`interchangeable', stakeholderand toolkits,clarification orregarding otherthe formats,use asof theinterchangeable Secretarybiosimilar determinesbiological appropriate;products;

``(B) shallinformation berelated presentedto indevelopment aprograms manner,for usingbiological simpleproducts, terminology,including thatbiosimilar isbiological easilyproducts comprehendedand byinterchangeable appropriatebiosimilar targetbiological audiences,products includingand accounting,relevant toclinical theconsiderations extentfor practicable,prescribers, forwhich varyingmay levelsinclude, ofas healthappropriate literacyand amongapplicable, patientsinformation andrelated caregivers;to the comparability of such biological products;

``(C) shallan beexplanation tailoredof for the uniqueprocess needsfor ofreporting appropriateadverse targetevents audiences,for including--biological ``(i)products, health care providers with prescribing authority or dispensing authority under applicable State law, including physicians,biosimilar nurses,biological nurseproducts practitioners,and physicianinterchangeable assistants,biosimilar pharmacists,biological andproducts; pharmacy technicians;

and ``(ii)``(D) patientsan explanation of the relationship between biosimilar biological products and caregivers;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.

and``(3) ``(D)Format.--The may,educational asmaterials appropriate,provided beunder additionallyparagraph tailored(1) tomay healthbe-- care``(A) providers practicing in specialtiesformats insuch whichas biologicalwebinars, productscontinuing commonlyeducation aremodules, prescribedvideos, orfact tosheets, patientinfographics, populationsstakeholder totoolkits, whomor biologicalother productsformats commonlyas areappropriate prescribedand orapplicable; administered.

``(3) Content.--Educational materials provided under paragraph (1) shall include explanations of-- ``(A) key statutory and regulatory``(B) definitions,tailored includingfor the definitionsunique needs of thehealth termscare `biosimilar'providers, andpatients, `interchangeable',caregivers, and clarificationother thataudiences, anas interchangeablethe productSecretary isdetermines notappropriate. superior in quality to a biosimilar biological product;

``(B)``(4) howOther theinformation.--In Secretaryaddition determinesto the safety,information purity,described andin potencyparagraph of(2), biologicalthe productsSecretary thatshall arecontinue to publish-- ``(A) the subjectsaction package of applicationseach biological product licensed under subsectionssubsection (a) andor (k) of section 351;

``(C)or the``(B) application of the samesummary qualityreview andof manufacturingeach standards for biological productsproduct underlicensed 351(a), biosimilar biological products under 351(k),subsection and(a) interchangeableor biological(k) productsof undersection 351(k)(4);351.

``(D)``(5) theConfidential developmentand programtrade andsecret totalityinformation.--This ofsubsection does not authorize the evidencedisclosure requiredof forany biosimilartrade biologicalsecret, productconfidential developmentcommercial andor howfinancial prescribersinformation, canor evaluateother suchmatter information;described in section 552(b) of title 5.

``(E)``(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 processeducation forof reportingsuch adverseproviders eventson forthe allprescribing of, and relevant clinical considerations with respect to, biological products, including biosimilar biological products and interchangeable biosimilar biological products;products.''.

``(F)Passed the relationshipSenate between--December ``(i)17, variation2020. among biological products licensed under section 351(k) and their reference products licensed under section 351(a);

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

``(G)Secretary. 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)116th whetherCONGRESS the2d roleSession ofS. analytical characterization is novel to biosimilar biological product development;

and1681 ``(I)_______________________________________________________________________ howAN theACT FoodTo andeducate Drughealth Administrationcare considersproviders biosimilarand biologicalthe productspublic toon bebiosimilar asbiological safeproducts, and effectivefor asother theirpurposes. 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.''.

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