Advancing Education on Biosimilars Act of 2020
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.)
The FDA may also maintain and operate a website to provide educational materials about biological products.
[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>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Measure laid before Senate by unanimous consent. (consideration: CR S7642-7643)
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7643)
Message on Senate action sent to the House.
Received in the House.
Held at the desk.
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