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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1681 Introduced in Senate (IS)]

<DOC>

116th CONGRESS
  1st Session
                                S. 1681

     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.

    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 2019''.

SEC. 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:

``SEC. 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.''.
                                 <all>
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