The Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2021 or the PASTEUR Act of 2021
This bill authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs, provides $11 billion in appropriations for activities under the bill, and contains other related provisions.
A manufacturer of a Food and Drug Administration-approved antimicrobial drug may apply to HHS to have the drug designated as a critical-need antimicrobial, and HHS may enter into a subscription contract for such a critical-need antimicrobial. The bill imposes certain requirements related to such contracts, including a mechanism to lower payments under the contract in certain instances to limit the manufacturer's revenue from the drug.
Furthermore, HHS and the Centers for Disease Control and Prevention (CDC) shall award grants to support efforts to encourage the appropriate use of antimicrobial drugs and efforts to combat antimicrobial resistance. The CDC shall also track and assess data relating to antibacterial resistance and human antibiotic use and make such data publicly available.
HHS shall also establish a Committee on Critical Need Antimicrobials. The committee shall develop a list of prioritized infections for which new antimicrobial drug development is needed, among other duties.
Within six years of the bill's enactment, the Government Accountability Office shall report to Congress a study on the bill's effectiveness in developing priority antimicrobial drugs.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3932 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 3932
To establish a program to develop antimicrobial innovations targeting
the most challenging pathogens and most threatening infections.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 16, 2021
Mr. Michael F. Doyle of Pennsylvania (for himself and Mr. Ferguson)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committees on Ways and
Means, Veterans' Affairs, Armed Services, the Judiciary, and Homeland
Security, for a period to be subsequently determined by the Speaker, in
each case for consideration of such provisions as fall within the
jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To establish a program to develop antimicrobial innovations targeting
the most challenging pathogens and most threatening infections.
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 ``Pioneering Antimicrobial
Subscriptions To End Up surging Resistance Act of 2021'' or the
``PASTEUR Act of 2021''.
SEC. 2. DEVELOPING ANTIMICROBIAL INNOVATIONS.
Title III of the Public Health Service Act (42 U.S.C. 241 et seq.)
is amended by adding at the end the following:
``PART W--DEVELOPING ANTIMICROBIAL INNOVATIONS
``SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION MODEL; ADVISORY
GROUP.
``(a) In General.--Not later than 60 days after the date of
enactment of this part, the Secretary shall establish a Committee on
Critical Need Antimicrobials and appoint members to the Committee.
``(b) Members.--
``(1) In general.--The Committee shall consist of at least
one representative from each of the National Institute of
Allergy and Infectious Diseases, the Centers for Disease
Control and Prevention, the Biomedical Advanced Research and
Development Authority, the Food and Drug Administration, the
Centers for Medicare & Medicaid Services, the Veterans Health
Administration, and the Department of Defense.
``(2) Chair.--The Secretary shall appoint one of the
members of the Committee to serve as the Chair of the
Committee.
``(c) Duties.--Not later than 1 year after the appointment of all
initial members of the Committee, the Secretary, in collaboration with
the Committee, and in consultation with the Critical Need
Antimicrobials Advisory Group established under subsection (g), shall
do the following:
``(1) Develop a list of infections for which new
antimicrobial drug development is needed, taking into account
organisms, sites of infection, and type of infections for which
there is an unmet medical need, findings from the most recent
report entitled `Antibiotic Resistance Threats in the United
States' issued by the Centers for Disease Control and
Prevention, or an anticipated unmet medical need, including a
potential global health security threat. For the list developed
under this paragraph, the Secretary, in collaboration with the
Committee, may use the infection list in such most recent
report for up to 3 years following the date of enactment of
this part and subsequently update the list under this paragraph
in accordance with subsection (e).
``(2) Develop regulations, in accordance with subsection
(d), outlining favored characteristics of critical need
antimicrobial drugs, that are evidence based, clinically
focused, and designed to treat the infections described in
paragraph (1), and establishing criteria for how each such
characteristic will adjust the monetary value of a subscription
contract awarded under subsection (f) or section 399QQ. The
favored characteristics shall be weighed for purposes of such
monetary value such that meeting certain characteristics, or
meeting more than one such characteristic, increases the
monetary value. Such favored characteristics of an
antimicrobial drug shall include--
``(A) treating infections on the list under
paragraph (1);
``(B) improving clinical outcomes for patients with
multi-drug-resistant infections;
``(C) being a first-approved antimicrobial drug
that has the potential to address unmet medical needs
for the treatment of a serious or life-threatening
infection, and, to a lesser extent, second and third
drugs that treat such infections;
``(D) route of administration, especially through
oral administration;
``(E)(i) containing no active moiety (as defined by
the Secretary in section 314.3 of title 21, Code of
Federal Regulations (or any successor regulations))
that has been approved in any other application under
section 505(b) of the Federal Food, Drug, and Cosmetic
Act or intending to be the subject of a new original
biologics license application under section 351(a);
``(ii) being a member of a new class of drugs with
a novel target and novel mode of action that are
distinctly different from the target or mode of any
antimicrobial drug approved under section 505 of such
Act or licensed under section 351, including reduced
toxicity;
``(iii) not being affected by cross-resistance to
any antimicrobial drug approved under such section 505
or licensed under such section 351;
``(F) addressing a multi-drug resistant infection
through a novel chemical scaffold or mechanism of
action;
``(G) having received a transitional subscription
contract under subsection (f); and
``(H) any other characteristic the Secretary, in
collaboration with the Committee, determines necessary.
``(d) Regulations.--
``(1) In general.--Not later than 1 year after the
appointment of the initial members of the Committee, the
Secretary shall issue proposed regulations which shall
include--
``(A) a process by which the sponsors can apply for
an antimicrobial drug to become a critical need
antimicrobial drug under section 399PP;
``(B) how subscription contracts under such section
shall be established and paid;
``(C) the favored characteristics under subsection
(c)(2), how such characteristics will be weighed, and
the minimum number and kind of favored characteristics
needed for an antimicrobial drug to be designated a
critical need antimicrobial drug; and
``(D) other elements of the subscription contract
process, in accordance with this part.
``(2) Development of final regulations.--Before finalizing
the regulations under paragraph (1), the Secretary shall
solicit public comment and hold public meetings for the period
beginning on the date on which the proposed regulations are
issued and ending on the date that is 120 days after such date
of issuance. The Secretary shall finalize and publish such
regulations not later than 120 days after the close of such
period of public comment and meetings.
``(3) Subscription contract office.--Not later than 6
months after the date of enactment of this part, the Secretary
shall propose an agency or office in the Department of Health
and Human Services to manage the establishment and payment of
subscription contracts awarded under section 399QQ, including
eligibility, requirements, and contract amounts. The Secretary
shall solicit public comment and finalize the agency or office
no later than 45 days following the proposed agency or office.
Such agency or office shall be referred to as the `Subscription
Contract Office'.
``(e) List of Infections.--The Secretary, in collaboration with the
Committee, shall update the list of infections under subsection (c)(1)
at least every 2 years.
``(f) Transitional Subscription Contracts.--
``(1) In general.--Not earlier than 30 days after the date
of enactment of this part and ending on the date that the
Secretary finalizes the subscription contract regulations under
subsection (d), the Secretary may use up to $1,000,000,000 of
the amount appropriated under section 399SS(a) to engage in
transitional subscription contracts of up to 3 years in length
with antimicrobial developers, as determined by the Secretary,
that have developed antimicrobial drugs treating infections
listed in the most recent report entitled `Antibiotic
Resistance Threats in the United States' issued by the Centers
for Disease Control and Prevention, and may include
antimicrobial drugs that are qualified infectious disease
products (as defined in section 505E(g) of the Federal Food,
Drug, and Cosmetic Act), innovative biological products, or
innovative drugs that achieve a clinical outcome through
immunomodulation. Such a contract may authorize the contractor
to use funds made available under the contract for completion
of postmarketing clinical studies, manufacturing, and other
preclinical and clinical efforts.
``(2) Requirements.--
``(A) In general.--The Secretary, through the
office described in paragraph (4), may enter into a
contract under paragraph (1)--
``(i) if the Secretary determines that the
antimicrobial drug is intended to treat an
infection for which there is an unmet clinical
need, an anticipated clinical need, or drug
resistance;
``(ii) subject to terms including--
``(I) that the Secretary shall
cease any payment installments under a
transitional subscription contract if
the sponsor does not--
``(aa) ensure commercial
and Federal availability of the
antimicrobial drug within 30
days of receiving first payment
under the contract;
``(bb) identify, track, and
publicly report drug resistance
data and trends using available
data related to the
antimicrobial drug;
``(cc) develop and
implement education and
communications strategies,
including communications for
individuals with limited
English proficiency and
individuals with disabilities,
for health care professionals
and patients about appropriate
use of the antimicrobial drug;
``(dd) submit a plan for
registering the antimicrobial
drug in additional countries
where an unmet medical need
exists, which such plan may be
consistent with the Stewardship
and Access Plan (SAP)
Development Guide (2021);
``(ee) subject to
subparagraph (B), ensure a
reliable drug supply chain,
thus leading to an interruption
of the supply of the
antimicrobial drug in the
United States for more than 60
days; or
``(ff) make meaningful
progress toward completion of
Food and Drug Administration-
required postmarketing studies,
including such studies that are
evidence based; and
``(II) other terms as determined by
the Secretary; and
``(iii) if--
``(I) a phase 3 clinical study has
been initiated for the antimicrobial
drug; or
``(II) the antimicrobial drug has
been approved under section 505(c) of
the Federal Food, Drug, and Cosmetic
Act or licensed under section 351(a).
``(B) Waiver.--The requirement under subparagraph
(A)(ii)(I)(ee) may be waived in the case that an
emergency prohibits access to a reliable drug supply
chain.
``(3) Transitional guidance.--Not later than 120 days after
the appointment of the initial members of the Committee, the
Secretary shall issue, in consultation with the Committee,
transitional guidance outlining the antimicrobial drugs that
are eligible for transitional subscription contracts under
paragraph (1), the requirements to enter into a transitional
subscription contract under paragraph (2), and the process by
which drug developers can enter into transitional subscription
contracts with the Secretary under this subsection.
``(4) Payment office and mechanism.--Not later than 30 days
after the date of enactment of this part, the Secretary shall
determine the agency or office in the Department of Health and
Human Services that will manage the transitional subscription
contracts, including eligibility, requirements, and contract
amounts, during the period described in paragraph (1).
``(g) Critical Need Antimicrobial Advisory Group.--
``(1) In general.--Not later than 30 days after the
appointment of all initial members of the Committee, the
Secretary, in collaboration with the Committee, shall establish
a Critical Need Antimicrobial Advisory Group (referred to in
this subsection as the `Advisory Group') and appoint members to
the Advisory Group.
``(2) Members.--The members of the Advisory Group shall
include--
``(A) not fewer than 6 individuals who are--
``(i) infectious disease specialists; or
``(ii) other health experts with expertise
in researching antimicrobial resistance, health
economics, or commercializing antimicrobial
drugs; and
``(B) not fewer than 5 patient advocates.
``(3) Chair.--The Secretary shall appoint one of the
members of the Advisory Group to serve as the Chair.
``(4) Conflicts of interest.--In appointing members under
paragraph (2), the Secretary shall ensure that no member
receives compensation in any manner from a commercial or for-
profit entity that develops antimicrobials or that might
benefit from antimicrobial development.
``(5) Applicability of faca.--Except as otherwise provided
in this subsection, the Federal Advisory Committee Act shall
apply to the Advisory Group.
``SEC. 399PP. CRITICAL NEED ANTIMICROBIAL DRUG APPLICATION AND PAYMENT
THROUGH SUBSCRIPTION CONTRACTS.
``(a) In General.--
``(1) Submission of request.--The sponsor of an application
under section 505(b) of the Federal Food, Drug, and Cosmetic
Act or section 351(a) for an antimicrobial drug may request
that the Secretary designate the drug as a critical need
antimicrobial. A request for such designation may be submitted
after the Secretary grants for such drug an investigational new
drug exemption under section 505(i) of the Federal Food, Drug,
and Cosmetic Act or section 351(a)(3), and shall be submitted
not later than 5 years after the date of approval under section
505(c) of the Federal Food, Drug, and Cosmetic Act or licensure
under section 351(a).
``(2) Content of request.--A request under paragraph (1)
shall include information, such as clinical, preclinical and
postmarketing data, a list of the favorable characteristics
described in section 399OO(c)(2), and any other material that
the Secretary in consultation with the Committee requires.
``(3) Review by secretary.--The Secretary shall promptly
review all requests for designation submitted under this
subsection, assess all required application components, and
determine if the antimicrobial drug is likely to meet the
favorable characteristics identified in the application upon
the completion of clinical development. After review, the
Secretary shall approve or deny each request for designation
not later than 90 days after receiving a request. If the
Secretary approves a request, it shall publish the value of the
contract that the critical need antimicrobial developer would
be eligible to receive if such developer successfully
demonstrates that the drug meets the maximum value of the
favored characteristics listed in the application.
``(4) Length of designation period.--A designation granted
under this section shall be in effect for a period of 10 years
after the date that the designation is approved, and shall
remain in effect for such period even if the infection treated
by such drug is later removed from the list of infections under
section 399OO(c)(1).
``(5) Subsequent reviews.--No sooner than 2 years after a
designation approval or denial under subsection (3), the
sponsor may request a subsequent review to re-evaluate the
value of a contract to include any new information.
``(b) Development of Designated Drugs.--If a critical need
antimicrobial designation is granted during clinical development of an
antimicrobial drug, the Secretary may work with the sponsor to maximize
the opportunity for the sponsor to successfully demonstrate that the
antimicrobial drug possesses the favored characteristics of high-
monetary valued products identified under section 399OO(c)(2).
``(c) Appropriate Use of Critical Need Antimicrobial.--
``(1) In general.--The sponsor of an antimicrobial drug
that receives designation under subsection (a) shall within 90
days of such designation, submit to the Secretary a plan for
appropriate use of diagnostics, in order for the Secretary and
Committee to consider such plan in developing clinical
guidelines. An appropriate use plan--
``(A) shall include--
``(i) the appropriate use of the drug; and
``(ii) the appropriate use of diagnostic
tools, where available, such as diagnostic
testing for biomarkers related to
antimicrobial-resistant pathogens, or other
targeted diagnostic approaches, to inform use
of the drug; and
``(B) may be developed in partnership with the
Secretary, infectious disease experts, diagnostic
experts or developers, laboratory experts, or another
entity.
``(2) Consultation.--The Secretary shall consult with
relevant professional societies and the Critical Need
Antimicrobial Advisory Group established under section 399OO(g)
to ensure that clinical guidelines issued by the Secretary
under paragraph (3), with respect to an antimicrobial drug
designated under subsection (a), includes the use of
appropriate diagnostic approaches, taking into consideration
the diagnostic plan submitted by a sponsor under paragraph (1).
``(3) Publication of clinical guidelines.--Not later than 1
year after the Secretary makes the first designation under
subsection (a), and not less than every 3 years thereafter, the
Secretary shall publish clinical guidelines in consultation
with relevant professional societies with respect to each
antimicrobial drug that has been approved or licensed as
described in subsection (a)(1) and that has been designated
under subsection (a), which guidelines shall set forth the
evidence-based recommendations for prescribing the drug, in
accordance with the submissions of the sponsor under paragraph
(1) and after consultation under paragraph (2), as appropriate.
``SEC. 399QQ. SUBSCRIPTION CONTRACTS.
``(a) Application for a Subscription Contract.--
``(1) Submission of applications.--After approval under
section 505(c) of the Federal Food, Drug, and Cosmetic Act or
licensure under section 351(a), the sponsor of an antimicrobial
drug designated as a critical need antimicrobial under section
399PP may submit an application for a subscription contract
with the Secretary, under a procedure established by the
Secretary.
``(2) Review of applications.--The Secretary shall, in
consultation with the Committee--
``(A) review all applications for subscription
contracts under paragraph (1) and assess all required
application components;
``(B) determine the extent to which the critical
need antimicrobial meets the favored characteristics
identified under section 399OO(c)(2), and deny any
application for a drug that meets none of such
characteristics; and
``(C) assign a monetary value to the contract based
on the regulations developed under section 399OO(d).
``(b) Criteria.--To qualify for a subscription contract under this
section, the sponsor of an antimicrobial drug designated as a critical
need antimicrobial shall agree to--
``(1) ensure commercial and Federal availability of the
antimicrobial drug within 30 days of receiving first payment
under the contract, and sufficient supply for susceptibility
device manufacturers;
``(2) identify, track, and publicly report drug resistance
data and trends using available data related to the
antimicrobial drug;
``(3) develop and implement education and communications
strategies, including communications for individuals with
limited English proficiency and individuals with disabilities,
for health care professionals and patients about appropriate
use of the antimicrobial drug;
``(4) submit an appropriate use assessment to the
Secretary, Committee, Food and Drug Administration, and Centers
for Disease Control and Prevention every 2 years regarding use
of the antimicrobial drug, including how the drug is being
marketed;
``(5) submit a plan for registering the drug in additional
countries where an unmet medical need exists;
``(6) ensure a reliable drug supply chain, where any
interruption to the supply chain will not last for more than 60
days in the United States;
``(7) complete any postmarketing studies required by the
Food and Drug Administration in a timely manner;
``(8) produce the drug at a reasonable volume determined
with the Secretary to ensure patient access to the drug;
``(9) price the drug at a price that is not lower than a
comparable generic drug;
``(10) abide by the manufacturing and environmental best
practices in the supply chain to ensure that there is no
discharge into, or contamination of, the environment by
antimicrobial agents or products as a result of the
manufacturing process; and
``(11) abide by other terms as the Secretary may require.
``(c) Amount and Terms of Contracts.--
``(1) Amounts.--A subscription contract under this section
shall be for the sale to the Secretary of any quantity of the
antimicrobial drug needed over the term of the contract under
paragraph (2), at an agreed upon price, for a total projected
amount determined by the Secretary that is not less than
$750,000,000 and not more than $3,000,000,000, adjusted for
inflation, accounting for the favored characteristics of the
drug, as determined by the Secretary, in consultation with the
Committee, under subsection (a)(2), and shall be allocated from
the amount made available under section 399SS(a). Not later
than 6 months after the subscription contract is granted under
subsection (a), the Secretary shall provide payments for
purchased drugs in installments established by the Secretary in
consultation with the sponsor of the antimicrobial drug and in
accordance with subsection (d)(3). Funds received by the
sponsor shall be used to support criteria qualification under
subsection (b), the completion of postmarketing clinical
studies, manufacturing, other preclinical and clinical
activities, or other activities agreed to by the Secretary and
sponsor in the contract.
``(2) Terms.--
``(A) Initial term.--The initial term of a contract
under this subsection shall be no less than 5 years or
greater than the greater of 10 years or the remaining
period of time during which the sponsor has patent
protections or a remaining exclusivity period with
respect to the antimicrobial drug in the United States,
as listed in the publication of the Food and Drug
Administration entitled `Approved Drug Products with
Therapeutic Equivalence Evaluations'. Payments may be
in equal annual installments with the option to redeem
50 percent of the last year's reimbursement in year 1
of the contract in order to offset costs of
establishing manufacturing capacity, or another
subscription arrangement to which the Secretary and
sponsor agree. Subscription contracts shall remain in
effect for such period even if the infection treated by
such antimicrobial drug is later removed from the list
of infections under section 399OO(c)(1).
``(B) Extension of contracts.--The Secretary may
extend a subscription contract with a sponsor under
this subsection beyond the initial contract period. A
single contract extension may be in effect not later
than the date on which all periods of exclusivity
granted by the Food and Drug Administration expire and
shall be in an amount not to exceed $25,000,000 per
year. All other terms of an extended contract shall be
the same as the terms of the initial contract. The
total amount of funding used on such contract
extensions shall be no more than $1,000,000,000, and
shall be allocated from the amount made available under
section 399SS.
``(C) Modification of contracts.--The Secretary or
sponsor, 1 year after the start of the contract period
under this subsection and every 2 years thereafter, may
request a modification of the amount of the contract
based on information that adjusts favored
characteristics in section 399OO(c)(2).
``(3) Adjustment.--In the case of an antimicrobial drug
that received a transitional subscription contract under
section 399OO(f), the amount of a subscription contract for
such drug under this section shall be reduced by the amount of
the transitional subscription contract under such section
399OO(f) for such drug.
``(4) Contracts for generic and biosimilar versions.--
Notwithstanding any other provision in this part, the Secretary
may award a subscription contract under this section to a
manufacturer of a generic or biosimilar version of an
antimicrobial drug for which a subscription contract has been
awarded under this section. Such contracts shall be awarded in
accordance with a procedure, including for determining the
terms and amounts of such contracts, established by the
Secretary.
``(d) Annual Antimicrobial Drug Sponsor Revenue Limitations.--
``(1) Reporting requirement.--
``(A) In general.--Not later than a date determined
appropriate by the Secretary following the end of each
calendar year, and not earlier than 6 months after the
end of each calendar year, the head (or a designee of
such head) of each Federal agency carrying out a
specified government program shall, in accordance with
this paragraph, report to the Subscription Contract
Office established under section 399OO(d)(3) the total
prescription drug sales for each applicable
antimicrobial drug under contract with respect to such
program for such calendar year.
``(B) Medicare part d program.--For purposes of
subparagraph (A), the Secretary shall report, for each
applicable antimicrobial drug covered under part D of
title XVIII of the Social Security Act, the product
of--
``(i) the per-unit ingredient cost, as
reported to the Secretary by prescription drug
plans and Medicare Advantage prescription drug
plans, minus any per-unit rebate, discount, or
other price concession provided by the sponsor
of such applicable antimicrobial drug, as
reported to the Secretary by the prescription
drug plans and the Medicare Advantage
prescription drug plans; and
``(ii) the number of units of such
applicable antimicrobial drug paid for under
such part D.
``(C) Medicare part b program.--
``(i) In general.--For purposes of
subparagraph (A), the Secretary shall report,
for each applicable antimicrobial drug covered
under part B of title XVIII of the Social
Security Act, the product of--
``(I) the per-unit average sales
price (as defined in section 1847A(c)
of such Act) or the per-unit payment
rate under such part B for a separately
paid prescription drug without a
reported average sales price; and
``(II) the number of units of such
applicable antimicrobial drug paid for
under such part B.
``(ii) Units and allocated prices.--The
Secretary shall establish a process for
determining the units and the allocated price
for purposes of this subparagraph for those
applicable antimicrobial drugs that are not
separately payable or for which National Drug
Codes are not reported.
``(D) Medicare part a program.--
``(i) In general.--For purposes of
subparagraph (A), the Secretary shall report,
for each applicable antimicrobial drug covered
under part A of title XVIII of the Social
Security Act, the product of--
``(I) the per-unit price under such
part A for the antimicrobial drug; and
``(II) the number of units of such
antimicrobial drug paid for under such
part A.
``(ii) Special rule.--For purposes of
clause (i), the Secretary shall establish a
process for determining the units and the
allocated price for those prescription drugs
that are not separately payable or for which
National Drug Codes are not reported in the
diagnosis-related groups.
``(E) Medicaid program.--Under the authority of
section 1902(a)(6) of the Social Security Act, the
Secretary shall require each State that makes medical
assistance available under the State plan under title
XIX of such Act (or any waiver of such plan) for an
applicable antimicrobial drug (including, if
applicable, any such drug which is a covered outpatient
drug under a rebate agreement entered into under
section 1927 of such Act) to report, in a form
consistent with a standard reporting format established
by the Secretary, not later than the date determined
under subparagraph (A)--
``(i) information on the total number of
units of each dosage form and strength and
package size of each applicable antimicrobial
drug dispensed during the preceding calendar
year under such State plan or waiver (including
any such drugs dispensed to an individual
enrolled with a medicaid managed care
organization or other specified entity (as such
terms are defined in section 1903(m) of such
Act)); and
``(ii) with respect to each dosage form and
strength and package size of each such drug,
the amount equal to--
``(I) the product of--
``(aa) the total number of
units dispensed under the State
plan or waiver during the
preceding calendar year (as
determined under clause (i));
and
``(bb) the per-unit
ingredient cost paid by the
State for each such unit; minus
``(II) any discounts or other price
concessions provided and rebates paid
to the State with respect to the dosage
form and strength and package size of
such drug and such calendar year
(including rebates paid under a rebate
agreement under section 1927 of such
Act and any State supplemental rebates
paid under a supplemental rebate
agreement).
``(F) Department of veterans affairs.--For purposes
of subparagraph (A), the Secretary of Veterans Affairs
shall report the total amount paid for each applicable
antimicrobial drug procured by the Veterans Health
Administration for individuals who receive health care
from the Administration.
``(G) Department of defense and tricare program.--
For purposes of subparagraph (A), the Secretary of
Defense shall report the sum of--
``(i) the total amount paid for each
applicable antimicrobial drug procured by the
Department of Defense for individuals who
receive health care from the Department; and
``(ii) for each applicable antimicrobial
drug dispensed under the TRICARE retail
pharmacy program under section
1074g(a)(2)(E)(ii) of title 10, United States
Code, the product of--
``(I) the per-unit ingredient cost,
minus any per-unit rebate paid by the
sponsor of the applicable antimicrobial
drug; and
``(II) the number of units of such
applicable antimicrobial drug dispensed
under such program.
``(H) Department of homeland security.--For
purposes of subparagraph (A), the Secretary of Homeland
Security shall report the total amount paid for each
applicable antimicrobial drug procured by the
Department of Homeland Security for individuals who
receive health care through a program carried out by
the Department.
``(I) Bureau of prisons.--For purposes of
subparagraph (A), the Director of the Bureau of Prisons
shall report the total amount paid for each applicable
antimicrobial drug procured by the Bureau of Prisons
for individuals who receive health care through the
Bureau.
``(J) Indian health service.--For purposes of
subparagraph (A), the Secretary, acting through the
Indian Health Service, shall report the total amount
paid for each applicable antimicrobial drug procured by
the Service for individuals who receive health care
through the Service.
``(2) Regulations.--Not later than 1 year after the date of
enactment of this part, the Secretary, in consultation with the
heads of Federal agencies carrying out specified government
programs, shall issue regulations to assist such heads (or
their designees) in carrying out the requirements under this
section.
``(3) Subscription contract adjustment.--Pursuant to the
contract entered into under this section with respect to an
applicable antimicrobial drug, for each year of the term of
such contract, the Secretary shall, not earlier than 6 months
after the end of each calendar year, subtract from the payment
installments determined for such contract under subsection
(c)(1) for such year the revenue of the sponsor of such drug
from the previous year from sales of the applicable
antimicrobial drug reported under paragraph (1) for specified
government programs.
``(4) Definitions.--In this subsection:
``(A) Applicable antimicrobial drug.--The term
`applicable antimicrobial drug' means an antimicrobial
drug for which the sponsor of such drug receives a
subscription contract under subsection (a).
``(B) Specified government program.--The term
`specified government program' means--
``(i) the Medicare part D program under
part D of title XVIII of the Social Security
Act;
``(ii) the Medicare Part B program under
part B of such title XVIII;
``(iii) the Medicare Part A program under
part A of such title XVIII;
``(iv) the Medicaid program established
under title XIX of the Social Security Act and
includes, with respect to a State, any waiver
in effect with respect to such program;
``(v) any program under which prescription
drugs are procured by the Department of
Veterans Affairs;
``(vi) any program under which prescription
drugs are procured by the Department of
Defense;
``(vii) the TRICARE retail pharmacy program
under section 1074g(a)(2)(E)(ii) of title 10,
United States Code;
``(viii) any program under which
prescription drugs are procured by the
Department of Homeland Security;
``(ix) any program under which prescription
drugs are procured by the Bureau of Prisons; or
``(x) any program under which prescription
drugs are procured by the Indian Health
Service.
``(e) Failure To Adhere to Terms.--The Secretary shall cease any
payment installments under a contract under this section if--
``(1) the sponsor--
``(A) permanently withdraws the antimicrobial drug
from the market in the United States;
``(B) fails to meet criteria under subsection (b);
or
``(C) does not complete a postmarket study required
by the Food and Drug Administration during the length
of the term of the contract;
``(2) the annual international and private insurance market
revenues with respect to an antimicrobial drug (not counting
any subscription revenues from any source pursuant to a
contract under this section or other international or private
entities) exceed 5 times the average annual amount of the
subscription contract paid by the Secretary as certified by the
sponsor annually; or
``(3) if the total revenue of the sponsor from specified
government programs, as defined in subsection (d)(4), for a
year exceeds the amount of the subscription contract paid by
the Secretary for that year.
``(f) Private Payer and International Payer Participation.--The
Secretary shall make efforts to increase the participation of domestic
private payors and international payors in subscription contracts or
other types of value-based arrangements that are similar to the
subscription contracts authorized under this section.
``SEC. 399RR. ENCOURAGING APPROPRIATE USE OF ANTIBIOTICS AND COMBATING
RESISTANCE.
``(a) Establishment of Hospital Grant Program.--
``(1) In general.--Not later than 1 year after the date of
enactment of this part, the Secretary and the Director of the
Centers for Disease Control and Prevention shall coordinate
with the Administrator of the Health Resources and Services
Administration, the Administrator of the Centers for Medicare &
Medicaid Services, the National Coordinator for Health
Information Technology, and other relevant agencies, to
establish a grant program under the Centers for Disease Control
and Prevention to support hospital and other inpatient facility
efforts--
``(A) to judiciously use antimicrobial drugs, such
as by establishing or implementing appropriate use
programs, including infectious disease telehealth
programs, using appropriate diagnostic tools,
partnering with academic hospitals, increasing health
care-associated infection reporting, and monitoring
antimicrobial resistance; and
``(B) to participate in the National Healthcare
Safety Network Antimicrobial Use and Resistance Module
or the Emerging Infections Program Healthcare-
Associated Infections Community Interface activity of
the Centers for Disease Control and Prevention or a
similar reporting program, as specified by the
Secretary, relating to antimicrobial drugs.
``(2) Prioritization.--In awarding grants under paragraph
(1), the Secretary shall prioritize hospitals without an
existing program to judiciously use antimicrobial drugs,
subsection (d) hospitals (as defined in subparagraph (B) of
section 1886(d)(2) of the Social Security Act that are located
in rural areas (as defined in subparagraph (D) of such
section), critical access hospitals (as defined in section
1861(mm)(1) of such Act), hospitals serving Tribal-populations,
and safety-net hospitals.
``(3) Funding.--Of the amounts appropriated under section
399SS, the Secretary shall reserve $500,000,000 to carry out
this subsection.
``(b) Surveillance and Reporting of Antibiotic Use and
Resistance.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall use the National Healthcare Safety Network and other
appropriate surveillance systems to assess--
``(A) appropriate conditions, outcomes, and
measures causally related to antibacterial resistance,
including types of infections, the causes for
infections, and whether infections are acquired in a
community or hospital setting, increased lengths of
hospital stay, increased costs, and rates of mortality;
and
``(B) changes in bacterial resistance to
antimicrobial drugs in relation to patient outcomes,
including changes in percent resistance, prevalence of
antibiotic-resistant infections, and other such
changes.
``(2) Antibiotic use data.--The Secretary, acting through
the Director of the Centers for Disease Control and Prevention,
shall work with Federal agencies (including the Department of
Veterans Affairs, the Department of Defense, the Department of
Homeland Security, the Bureau of Prisons, the Indian Health
Service, and the Centers for Medicare & Medicaid Services),
private vendors, health care organizations, pharmacy benefit
managers, and other entities as appropriate to obtain reliable
and comparable human antibiotic drug consumption data
(including, as available and appropriate, volume antibiotic
distribution data and antibiotic use data, including
prescription data) by State or metropolitan areas.
``(3) Antibiotic resistance trend data.--The Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, shall intensify and expand efforts to collect
antibiotic resistance data and encourage adoption of the
Antibiotic Use and Resistance Module within the National
Healthcare Safety Network among all health care facilities
across the continuum of care, including, as appropriate, acute
care hospitals, dialysis facilities, nursing homes, ambulatory
surgical centers, and other ambulatory health care settings in
which antimicrobial drugs are routinely prescribed. The
Secretary shall seek to collect such data from electronic
medication administration reports and laboratory systems to
produce the reports described in paragraph (4).
``(4) Public availability of data.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall, for the purposes of improving the monitoring
of important trends in patient outcomes in relation to
antibacterial resistance--
``(A) make the data derived from surveillance under
this subsection publicly available through reports
issued on a regular basis that is not less than
annually; and
``(B) examine opportunities to make such data
available in near real time.
``SEC. 399SS. APPROPRIATIONS.
``(a) In General.--To carry out this part, there are hereby
appropriated to the Secretary, out of amounts in the Treasury not
otherwise appropriated, $11,000,000,000, for fiscal year 2022, to
remain available until expended.
``(b) Emergency Designation.--
``(1) In general.--The amounts provided by this section are
designated as an emergency requirement pursuant to section 4(g)
of the Statutory Pay-As-You-Go Act of 2010.
``(2) Designation in senate.--In the Senate, this section
is designated as an emergency requirement pursuant to section
4112(a) of H. Con. Res. 71 (115th Congress), the concurrent
resolution on the budget for fiscal year 2018.
``SEC. 399TT. STUDIES AND REPORTS.
``(a) In General.--Not later than 6 years after the date of
enactment of this part, the Comptroller General of the United States
shall complete a study on the effectiveness of this part in developing
priority antimicrobial drugs. Such study shall examine the indications
for, usage of, development of resistance with respect to, and private
and societal value of critical need antimicrobial drugs, and the impact
of the programs under this part on patients and markets of critical
need antimicrobial drugs. The Comptroller General shall report to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives on
the findings of such study.
``(b) Antibiotic Use in the United States; Annual Reports.--The
Director of the Centers for Disease Control and Prevention shall, each
year, update the report entitled `Antibiotic Use in the United States'
to include updated information on progress and opportunities with
respect to data, programs, and resources for prescribers to promote
appropriate use of antimicrobial drugs.
``(c) Report on Antimicrobial Prophylactics.--Not later than 3
years after the date of enactment of this part, the Director of the
Centers for Disease Control and Prevention shall publish a report on
antimicrobial prophylactics.
``SEC. 399UU. DEFINITIONS.
``In this part--
``(1) the term `antimicrobial drug'--
``(A) means, subject to subparagraph (B), a product
that is--
``(i) a drug that directly inhibits
replication of or kills bacteria or fungi
relevant to the proposed indication at
concentrations likely to be attainable in
humans to achieve the intended therapeutic
effect; or
``(ii) a biological product that acts
directly on bacteria or fungi or on the
substances produced by such bacteria or fungi;
and
``(B) does not include--
``(i) a drug that achieves the effect
described by subparagraph (A)(i) only at a
concentration that cannot reasonably be studied
in humans because of its anticipated toxicity;
or
``(ii) a vaccine; and
``(2) the term `Committee' means the Committee on Critical
Need Antimicrobials established under section 399OO.''.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Veterans' Affairs, Armed Services, the Judiciary, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Veterans' Affairs, Armed Services, the Judiciary, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Veterans' Affairs, Armed Services, the Judiciary, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Veterans' Affairs, Armed Services, the Judiciary, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Veterans' Affairs, Armed Services, the Judiciary, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Veterans' Affairs, Armed Services, the Judiciary, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Oversight, Management, and Accountability.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.