[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1269 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 1269
To reduce the price of insulin and provide for patient protections with
respect to the cost of insulin.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 25, 2023
Mrs. Shaheen (for herself and Ms. Collins) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To reduce the price of insulin and provide for patient protections with
respect to the cost of insulin.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Improving Needed
Safeguards for Users of Lifesaving Insulin Now Act of 2023'' or the
``INSULIN Act of 2023''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--COMMERCIAL MARKET PATIENT PROTECTIONS
Sec. 101. Requirements with respect to cost-sharing for certain insulin
products.
Sec. 102. Application to retiree and certain small group plans.
Sec. 103. Administration.
TITLE II--PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE REFORM
Sec. 201. Full rebate on insulin pass-through to plan.
TITLE III--BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC DRUG COMPETITION
AND AFFORDABILITY
Sec. 301. Ensuring timely access to generics.
Sec. 302. Permitted mid-year changes in Medicare part D plan
formularies for certain biosimilar
biological products and the reference
product of such biosimilars.
Sec. 303. Expediting competitive biosimilar competition.
Sec. 304. Insulin competition report.
TITLE I--COMMERCIAL MARKET PATIENT PROTECTIONS
SEC. 101. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN INSULIN
PRODUCTS.
(a) In General.--Part D of title XXVII of the Public Health Service
Act (42 U.S.C. 300gg-111 et seq.) is amended by adding at the end the
following:
``SEC. 2799A-11. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2024, a group health plan or health insurance issuer offering group or
individual health insurance coverage shall provide coverage of selected
insulin products, and with respect to such products, shall not--
``(1) apply any deductible; or
``(2) impose any cost-sharing requirements in excess of,
per 30-day supply--
``(A) for any applicable plan year beginning before
January 1, 2025, $35; or
``(B) for any plan year beginning on or after
January 1, 2025, the lesser of--
``(i) $35; or
``(ii) the amount equal to 25 percent of
the negotiated price of the selected insulin
product net of all price concessions received
by or on behalf of the plan or issuer,
including price concessions received by or on
behalf of third-party entities providing
services to the plan or issuer, such as
pharmacy benefit management services or third
party administrators.
``(b) Definitions.--In this section:
``(1) Selected insulin products.--The term `selected
insulin products' means, for any plan year beginning on or
after January 1, 2024, at least one of each dosage form (such
as vial, pen, or inhaler dosage forms) of each different type
(such as rapid-acting, short-acting, intermediate-acting, long-
acting, and pre-mixed) of insulin, when such form is licensed
and marketed, as selected by the group health plan or health
insurance issuer.
``(2) Insulin.--The term `insulin' means insulin that is
licensed under subsection (a) or (k) of section 351 and
continues to be marketed pursuant to such licensure.
``(c) Out-of-Network Providers.--Nothing in this section requires a
plan or issuer that has a network of providers to provide benefits for
selected insulin products described in this section that are delivered
by an out-of-network provider, or precludes a plan or issuer that has a
network of providers from imposing higher cost-sharing than the levels
specified in subsection (a) for selected insulin products described in
this section that are delivered by an out-of-network provider.
``(d) Rule of Construction.--Subsection (a) shall not be construed
to require coverage of, or prevent a group health plan or health
insurance coverage from imposing cost-sharing other than the levels
specified in subsection (a) on, insulin products that are not selected
insulin products, to the extent that such coverage is not otherwise
required and such cost-sharing is otherwise permitted under Federal and
applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and Out-of-
Pocket Maximums.--Any cost-sharing payments made pursuant to subsection
(a)(2) shall be counted toward any deductible or out-of-pocket maximum
that applies under the plan or coverage.
``(f) Other Requirements.--A group health plan or health insurance
issuer offering group or individual health insurance coverage shall not
impose, directly or through an entity providing pharmacy benefit
management services, any prior authorization or other medical
management requirement, or other similar conditions, on selected
insulin products, except as clinically justified for safety reasons, to
ensure reasonable quantity limits and as specified by the Secretary.''.
(b) No Effect on Other Cost-Sharing.--Section 1302(d)(2) of the
Patient Protection and Affordable Care Act (42 U.S.C. 18022(d)(2)) is
amended by adding at the end the following new subparagraph:
``(D) Special rule relating to insulin coverage.--
For plans years beginning on or after January 1, 2025,
the exemption of coverage of selected insulin products
(as defined in section 2799A-11(b) of the Public Health
Service Act) from the application of any deductible
pursuant to section 2799A-11(a)(1) of such Act, section
726(a)(1) of the Employee Retirement Income Security
Act of 1974, or section 9826(a)(1) of the Internal
Revenue Code of 1986 shall not be considered when
determining the actuarial value of a qualified health
plan under this subsection.''.
(c) Coverage of Certain Insulin Products Under Catastrophic
Plans.--Section 1302(e) of the Patient Protection and Affordable Care
Act (42 U.S.C. 18022(e)) is amended by adding at the end the following:
``(4) Coverage of certain insulin products.--
``(A) In general.--Notwithstanding paragraph
(1)(B)(i), a health plan described in paragraph (1)
shall provide coverage of selected insulin products, in
accordance with section 2799A-11 of the Public Health
Service Act, before an enrolled individual has
incurred, during the plan year, cost-sharing expenses
in an amount equal to the annual limitation in effect
under subsection (c)(1) for the plan year.
``(B) Terminology.--For purposes of subparagraph
(A)--
``(i) the term `selected insulin products'
has the meaning given such term in section
2799A-11(b) of the Public Health Service Act;
and
``(ii) the requirements of section 2799A-11
of such Act shall be applied by deeming each
reference in such section to `individual health
insurance coverage' to be a reference to a plan
described in paragraph (1).''.
(d) ERISA.--
(1) In general.--Subpart B of part 7 of subtitle B of title
I of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1185 et seq.) is amended by adding at the end the
following:
``SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2024, a group health plan or health insurance issuer offering group
health insurance coverage shall provide coverage of selected insulin
products, and with respect to such products, shall not--
``(1) apply any deductible; or
``(2) impose any cost-sharing requirements in excess of,
per 30-day supply--
``(A) for any applicable plan year beginning before
January 1, 2025, $35; or
``(B) for any plan year beginning on or after
January 1, 2025, the lesser of--
``(i) $35; or
``(ii) the amount equal to 25 percent of
the negotiated price of the selected insulin
product net of all price concessions received
by or on behalf of the plan or issuer,
including price concessions received by or on
behalf of third-party entities providing
services to the plan or issuer, such as
pharmacy benefit management services or third
party administrators.
``(b) Definitions.--In this section:
``(1) Selected insulin products.--The term `selected
insulin products' means, for any plan year beginning on or
after January 1, 2024, at least one of each dosage form (such
as vial, pen, or inhaler dosage forms) of each different type
(such as rapid-acting, short-acting, intermediate-acting, long-
acting, and pre-mixed) of insulin, when such form is licensed
and marketed, as selected by the group health plan or health
insurance issuer.
``(2) Insulin.--The term `insulin' means insulin that is
licensed under subsection (a) or (k) of section 351 of the
Public Health Service Act (42 U.S.C. 262) and continues to be
marketed pursuant to such licensure.
``(c) Out-of-Network Providers.--Nothing in this section requires a
plan or issuer that has a network of providers to provide benefits for
selected insulin products described in this section that are delivered
by an out-of-network provider, or precludes a plan or issuer that has a
network of providers from imposing higher cost-sharing than the levels
specified in subsection (a) for selected insulin products described in
this section that are delivered by an out-of-network provider.
``(d) Rule of Construction.--Subsection (a) shall not be construed
to require coverage of, or prevent a group health plan or health
insurance coverage from imposing cost-sharing other than the levels
specified in subsection (a) on, insulin products that are not selected
insulin products, to the extent that such coverage is not otherwise
required and such cost-sharing is otherwise permitted under Federal and
applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and Out-of-
Pocket Maximums.--Any cost-sharing payments made pursuant to subsection
(a)(2) shall be counted toward any deductible or out-of-pocket maximum
that applies under the plan or coverage.
``(f) Other Requirements.--A group health plan or health insurance
issuer offering group health insurance coverage shall not impose,
directly or through an entity providing pharmacy benefit management
services, any prior authorization or other medical management
requirement, or other similar conditions, on selected insulin products,
except as clinically justified for safety reasons, to ensure reasonable
quantity limits and as specified by the Secretary.''.
(2) Clerical amendment.--The table of contents in section 1
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1001 et seq.) is amended by inserting after the item
relating to section 725 the following:
``Sec. 726. Requirements with respect to cost-sharing for certain
insulin products.''.
(e) Internal Revenue Code.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by adding at the end
the following new section:
``SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2024, a group health plan shall provide coverage of selected insulin
products, and with respect to such products, shall not--
``(1) apply any deductible; or
``(2) impose any cost-sharing requirements in excess of,
per 30-day supply--
``(A) for any applicable plan year beginning before
January 1, 2025, $35; or
``(B) for any plan year beginning on or after
January 1, 2025, the lesser of--
``(i) $35; or
``(ii) the amount equal to 25 percent of
the negotiated price of the selected insulin
product net of all price concessions received
by or on behalf of the plan, including price
concessions received by or on behalf of third-
party entities providing services to the plan,
such as pharmacy benefit management services or
third party administrators.
``(b) Definitions.--In this section:
``(1) Selected insulin products.--The term `selected
insulin products' means, for any plan year beginning on or
after January 1, 2024, at least one of each dosage form (such
as vial, pen, or inhaler dosage forms) of each different type
(such as rapid-acting, short-acting, intermediate-acting, long-
acting, and pre-mixed) of insulin, when such form is licensed
and marketed, as selected by the group health plan.
``(2) Insulin.--The term `insulin' means insulin that is
licensed under subsection (a) or (k) of section 351 of the
Public Health Service Act (42 U.S.C. 262) and continues to be
marketed pursuant to such licensure.
``(c) Out-of-Network Providers.--Nothing in this section requires a
plan that has a network of providers to provide benefits for selected
insulin products described in this section that are delivered by an
out-of-network provider, or precludes a plan that has a network of
providers from imposing higher cost-sharing than the levels specified
in subsection (a) for selected insulin products described in this
section that are delivered by an out-of-network provider.
``(d) Rule of Construction.--Subsection (a) shall not be construed
to require coverage of, or prevent a group health plan from imposing
cost-sharing other than the levels specified in subsection (a) on,
insulin products that are not selected insulin products, to the extent
that such coverage is not otherwise required and such cost-sharing is
otherwise permitted under Federal and applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and Out-of-
Pocket Maximums.--Any cost-sharing payments made pursuant to subsection
(a)(2) shall be counted toward any deductible or out-of-pocket maximum
that applies under the plan.
``(f) Other Requirements.--A group health plan shall not impose,
directly or through an entity providing pharmacy benefit management
services, any prior authorization or other medical management
requirement, or other similar conditions, on selected insulin products,
except as clinically justified for safety reasons, to ensure reasonable
quantity limits and as specified by the Secretary''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of such Code, as amended by section
102(c)(2), is further amended by adding at the end the
following new item:
``Sec. 9827. Requirements with respect to cost-sharing for certain
insulin products.''.
SEC. 102. APPLICATION TO RETIREE AND CERTAIN SMALL GROUP PLANS.
(a) ERISA.--Section 732(a) of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1191a(a)) is amended by striking
``section 711'' and inserting ``sections 711 and 726''.
(b) IRC.--The Internal Revenue Code of 1986 is amended--
(1) in section 9831(a), by adding at the end the following
flush text:
``Paragraph (2) shall not apply to the requirements under sections 9811
and 9826.''; and
(2) in section 4980D(d)(1), by striking ``section 9811''
and inserting ``sections 9811 and 9826''.
SEC. 103. ADMINISTRATION.
(a) Implementation.--Notwithstanding any other provision of law,
the Secretary of Health and Human Services, the Secretary of Labor, and
the Secretary of the Treasury may implement the provisions of,
including the amendments made by, this title for plan years that begin
on or after January 1, 2024, and end not later than January 1, 2027, by
subregulatory guidance, program instruction, or otherwise.
(b) Non-Application of the Paperwork Reduction Act.--Chapter 35 of
title 44, United States Code (commonly referred to as the ``Paperwork
Reduction Act of 1995''), shall not apply to the provisions of,
including the amendments made by, this title.
TITLE II--PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE REFORM
SEC. 201. FULL REBATE ON INSULIN PASS-THROUGH TO PLAN.
Part A of title XXVII of the Public Health Service Act (42 U.S.C.
300gg et seq.) is further amended by adding at the end the following:
``SEC. 2729A. FULL REBATE ON INSULIN PASS-THROUGH TO PLAN.
``(a) In General.--A pharmacy benefits manager, a third-party
administrator of a group health plan, a health insurance issuer
offering group health insurance coverage, or an entity providing
pharmacy benefits management services under such health plan or health
insurance coverage shall remit 100 percent of rebates, fees,
alternative discounts, and all other remuneration received from a
pharmaceutical manufacturer, distributor or any other third party, that
are related to utilization of insulin under such health plan or health
insurance coverage, to the group health plan.
``(b) Form and Manner of Remittance.--Such rebates, fees,
alternative discounts, and other remuneration shall be--
``(1) remitted to the group health plan in a timely fashion
after the period for which such rebates, fees, or other
remuneration is calculated, and in no case later than 90 days
after the end of such period;
``(2) fully disclosed and enumerated to the group health
plan sponsor; and
``(3) available for audit by the plan sponsor, or a third-
party designated by a plan sponsor no less than once per plan
year.''.
TITLE III--BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC DRUG COMPETITION
AND AFFORDABILITY
SEC. 301. ENSURING TIMELY ACCESS TO GENERICS.
Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(q)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)(i), by inserting ``,
10.31,'' after ``10.30'';
(B) in subparagraph (E)--
(i) by striking ``application and'' and
inserting ``application or'';
(ii) by striking ``If the Secretary'' and
inserting the following:
``(i) In general.--If the Secretary''; and
(iii) by striking the second sentence and
inserting the following:
``(ii) Primary purpose of delaying.--
``(I) In general.--In determining
whether a petition was submitted with
the primary purpose of delaying an
application, the Secretary may consider
the following factors:
``(aa) Whether the petition
was submitted in accordance
with paragraph (2)(B), based on
when the petitioner knew or
reasonably should have known
the relevant information relied
upon to form the basis of such
petition.
``(bb) Whether the
petitioner has submitted
multiple or serial petitions or
supplements to petitions
raising issues that reasonably
could have been known to the
petitioner at the time of
submission of the earlier
petition or petitions.
``(cc) Whether the petition
was submitted close in time to
a known, first date upon which
an application under subsection
(b)(2) or (j) of this section
or section 351(k) of the Public
Health Service Act could be
approved.
``(dd) Whether the petition
was submitted without relevant
data or information in support
of the scientific positions
forming the basis of such
petition.
``(ee) Whether the petition
raises the same or
substantially similar issues as
a prior petition to which the
Secretary has responded
substantively already,
including if the subsequent
submission follows such
response from the Secretary
closely in time.
``(ff) Whether the petition
requests changing the
applicable standards that other
applicants are required to
meet, including requesting
testing, data, or labeling
standards that are more onerous
or rigorous than the standards
the Secretary has determined to
be applicable to the listed
drug, reference product, or
petitioner's version of the
same drug.
``(gg) The petitioner's
record of submitting petitions
to the Food and Drug
Administration that have been
determined by the Secretary to
have been submitted with the
primary purpose of delay.
``(hh) Other relevant and
appropriate factors, which the
Secretary shall describe in
guidance.
``(II) Guidance.--The Secretary may
issue or update guidance, as
appropriate, to describe factors the
Secretary considers in accordance with
subclause (I).'';
(C) by adding at the end the following:
``(iii) Referral to the federal trade
commission.--The Secretary shall establish
procedures for referring to the Federal Trade
Commission any petition or supplement to a
petition that the Secretary determines was
submitted with the primary purpose of delaying
approval of an application. Such procedures
shall include notification to the petitioner by
the Secretary.'';
(D) by striking subparagraph (F);
(E) by redesignating subparagraphs (G) through (I)
as subparagraphs (F) through (H), respectively; and
(F) in subparagraph (H), as so redesignated, by
striking ``submission of this petition'' and inserting
``submission of this document'';
(2) in paragraph (2)--
(A) by redesignating subparagraphs (A) through (C)
as subparagraphs (C) through (E), respectively;
(B) by inserting before subparagraph (C), as so
redesignated, the following:
``(A) In general.--A person shall submit a petition
to the Secretary under paragraph (1) before filing a
civil action in which the person seeks to set aside,
delay, rescind, withdraw, or prevent submission,
review, or approval of an application submitted under
subsection (b)(2) or (j) of this section or section
351(k) of the Public Health Service Act. Such petition
and any supplement to such a petition shall describe
all information and arguments that form the basis of
the relief requested in any civil action described in
the previous sentence.
``(B) Timely submission of citizen petition.--A
petition and any supplement to a petition shall be
submitted within 60 days after the person knew, or
reasonably should have known, the information that
forms the basis of the request made in the petition or
supplement.'';
(C) in subparagraph (C), as so redesignated--
(i) in the heading, by striking ``within
150 days'';
(ii) in clause (i), by striking ``during
the 150-day period referred to in paragraph
(1)(F),''; and
(iii) by amending clause (ii) to read as
follows:
``(ii) on or after the date that is 151
days after the date of submission of the
petition, the Secretary approves or has
approved the application that is the subject of
the petition without having made such a final
decision.'';
(D) by amending subparagraph (D), as so
redesignated, to read as follows:
``(D) Dismissal of certain civil actions.--
``(i) Petition.--If a person files a civil
action against the Secretary in which a person
seeks to set aside, delay, rescind, withdraw,
or prevent submission, review, or approval of
an application submitted under subsection
(b)(2) or (j) of this section or section 351(k)
of the Public Health Service Act without
complying with the requirements of subparagraph
(A), the court shall dismiss without prejudice
the action for failure to exhaust
administrative remedies.
``(ii) Timeliness.--If a person files a
civil action against the Secretary in which a
person seeks to set aside, delay, rescind,
withdraw, or prevent submission, review, or
approval of an application submitted under
subsection (b)(2) or (j) of this section or
section 351(k) of the Public Health Service Act
without complying with the requirements of
subparagraph (B), the court shall dismiss with
prejudice the action for failure to timely file
a petition.
``(iii) Final response.--If a civil action
is filed against the Secretary with respect to
any issue raised in a petition timely filed
under paragraph (1) in which the petitioner
requests that the Secretary take any form of
action that could, if taken, set aside, delay,
rescind, withdraw, or prevent submission,
review, or approval of an application submitted
under subsection (b)(2) or (j) of this section
or section 351(k) of the Public Health Service
Act before the Secretary has taken final agency
action on the petition within the meaning of
subparagraph (C), the court shall dismiss
without prejudice the action for failure to
exhaust administrative remedies.''; and
(E) in clause (iii) of subparagraph (E), as so
redesignated, by striking ``as defined under
subparagraph (2)(A)'' and inserting ``within the
meaning of subparagraph (C)''; and
(3) in paragraph (4)--
(A) by striking ``Exceptions'' and all that follows
through ``This subsection does'' and inserting
``Exceptions.--This subsection does'';
(B) by striking subparagraph (B); and
(C) by redesignating clauses (i) and (ii) as
subparagraphs (A) and (B), respectively, and adjusting
the margins accordingly.
SEC. 302. PERMITTED MID-YEAR CHANGES IN MEDICARE PART D PLAN
FORMULARIES FOR CERTAIN BIOSIMILAR BIOLOGICAL PRODUCTS
AND THE REFERENCE PRODUCT OF SUCH BIOSIMILARS.
(a) In General.--Section 1860D-4(b) of the Social Security Act (42
5 U.S.C. 1395w-104(b)) is amended by adding at the end the following
new paragraph:
``(5) Mid-year changes in formularies permitted for certain
biosimilar biological products and the reference product of
such biosimilars.--If a PDP sponsor of a prescription drug plan
uses a formulary (including the use of tiered cost-sharing),
the following shall apply:
``(A) In general.--For plan year 2024, and
subsequent plan years, in the case of a covered part D
drug that is the reference biological product (as
defined in section 1847A(c)(6)(I)) with respect to a
biosimilar biological product (as defined in section
1847A(c)(6)(H)), the PDP sponsor may, with respect to a
formulary, at any time after the first 60 days of the
plan year, subject to paragraph (3)(E), change the
preferred or tiered cost-sharing status of such
reference biological product if such PDP sponsor adds,
at the same time, to such formulary such biosimilar
biological product at the same or a higher preferred
status, or to the same or lower cost-sharing tier, as
that of such reference biological product immediately
prior to such change.
``(B) Request for approval of change.--Prior to
making a change described in clause (i), the PDP
sponsor shall submit to the Secretary a request to make
such change. If the Secretary approves the request or
has not provided a decision to the PDP sponsor
regarding such request within 30 days of receiving such
request, such PDP sponsor may make such change.''.
(b) Administration.--
(1) Implementation.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services may implement
the amendment made by subsection (a) by subregulatory guidance,
program instruction, or otherwise.
(2) Non-application of the paperwork reduction act.--
Chapter 35 of title 44, United States Code (commonly referred
to as the ``Paperwork Reduction Act of 1995''), shall not apply
to the implementation of the amendment made by subsection (a).
SEC. 303. EXPEDITING COMPETITIVE BIOSIMILAR COMPETITION.
(a) In General.--Section 351(k) of the Public Health Service Act
(42 U.S.C. 262(k)) is amended by adding at the end the following:
``(10) Expediting competitive biosimilar competition.--
``(A) In general.--The Secretary may, at the
request of the sponsor of an application under this
subsection for a biosimilar biological product that is
designated as a competitive biosimilar therapy pursuant
to subsection (b), expedite the development and review
of such application under this subsection.
``(B) Designation process.--
``(i) Request.--The sponsor of an
application under this subsection may request
the Secretary to designate the drug as a
competitive biosimilar therapy. A request for
such designation may be made concurrently with,
or at any time prior to, the submission of a
biosimilar biological product license
application under this subsection.
``(ii) Criteria.--A biological product is
eligible for designation as a competitive
biosimilar therapy under this paragraph if the
Secretary determines that there is inadequate
biosimilar competition.
``(iii) Designation.--Not later than 60
calendar days after the receipt of a request
under clause (i), the Secretary may--
``(I) determine whether the
biosimilar biological product that is
the subject of the request meets the
criteria described in clause (ii); and
``(II) if the Secretary finds that
such product meets such criteria,
designate the biosimilar biological
product as a competitive biosimilar
therapy.
``(C) Actions.--In expediting the development and
review of an application under subparagraph (A), the
Secretary may, as requested by the applicant, take
actions including the following:
``(i) Hold meetings with the sponsor and
the review team throughout the development of
the biosimilar biological product prior to
submission of the application under this
subsection.
``(ii) Provide timely advice to, and
interactive communication with, the sponsor
regarding the development of the drug to ensure
that the development program to gather the data
necessary for approval is as efficient as
practicable.
``(iii) Involve senior managers and
experienced review staff, as appropriate, in a
collaborative, coordinated review of such
application, including with respect to
biological product-device combination products
and other complex products.
``(iv) Assign a cross-disciplinary project
lead--
``(I) to facilitate an efficient
review of the development program and
application, including manufacturing
inspections; and
``(II) to serve as a scientific
liaison between the review team and the
applicant.
``(D) Inspections.--With respect to an application
described in subparagraph (A), in the case of an
inspection report that finds approval of such
biological product is dependent upon remediation of a
facility, if the applicant attests that necessary
changes have been made to the facility, the Secretary
shall expedite reinspection of such facility, including
establishing a set timeline to reinspect the facility
or make a determination about the response of the
applicant and whether to approve the application.
``(E) Reporting requirement.--Not later than 1 year
after the date of licensure under this subsection with
respect to a biosimilar biological product for which
the development and review is expedited under this
paragraph, the holder of the license of such biosimilar
biological product shall report to the Secretary on
whether the biosimilar biological product has been
marketed in interstate commerce since the date of such
licensure.
``(F) Inadequate biosimilar competition.--In this
paragraph, the term `inadequate biosimilar competition'
means, with respect to a biological product, there are
fewer than 3 licensed biological products on the list
published under paragraph (9)(A) (not including
biological products on the discontinued section of such
list) that are biosimilar biological products with the
same reference product.''.
SEC. 304. INSULIN COMPETITION REPORT.
Not later than 1 year after the date of the enactment of this Act,
the Secretary of Health and Human Services, in collaboration with the
Administrator for the Centers for Medicare & Medicaid Services and the
Commissioner of Food and Drugs, shall--
(1) complete a study to determine the extent of, and causes
of, delays in getting insulin products to market, and the
market dynamics and extent biosimilar biological product
development and competition could increase, or is increasing,
the number of biological products approved and available to
patients, including by examining barriers to--
(A) placement of biosimilar biological products on
health insurance formularies;
(B) market entry of insulin product in the United
States, as compared to other highly developed nations;
and
(C) patient and provider education around
biosimilar biological products; and
(2) submit a report to Congress that describes the results
of the study conducted pursuant to paragraph (1) and
recommended policy solutions.
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