[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2940 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 2940
To amend title III of the Public Health Service Act to establish a
program to develop antimicrobial innovations targeting the most
challenging pathogens and most threatening infections, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 27, 2023
Mr. Ferguson (for himself, Mr. Peters, Mr. LaTurner, and Mr. Levin)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committees on Oversight and
Accountability, Ways and Means, and the Budget, 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 amend title III of the Public Health Service Act to establish a
program to develop antimicrobial innovations targeting the most
challenging pathogens and most threatening infections, 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 ``Pioneering Antimicrobial
Subscriptions To End Upsurging Resistance Act of 2023'' or the
``PASTEUR Act of 2023''.
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 as the Chair of
the Committee a non-voting, independent member who may not be a
member of the Committee or from an organization represented
under paragraph (1).
``(3) Consultation.--The Secretary shall consult with the
Under Secretary of Veterans Affairs for Health and Secretary of
Defense when appointing members from the Veterans Health
Administration and the Department of Defense.
``(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
Antibiotic Resistance Threats in the United States 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, for purposes of 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 or combinations of multiple characteristics will
adjust the monetary value of a subscription contract awarded
under subsection (f) or section 399OO-2. The favored
characteristics shall be weighed for purposes of such monetary
value of the subscription contract such that meeting certain
characteristics, or meeting more than one such characteristic,
increases the monetary value of the subscription contract. 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, or has the evidence
of addressing, 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 biological
product license application under section 351(a);
``(ii) being a member of a new class of drugs with
a novel target or 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; or
``(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 Committee or the
Critical Need Antimicrobial Advisory Group established
under subsection (g) determines necessary.
``(d) Regulations.--
``(1) In general.--Not later than 18 months 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 399OO-1;
``(B) how subscription contracts under section
399OO-2 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 150 days after such date
of issuance. The Secretary shall finalize and publish such
regulations not later than 150 days after the close of such
period of public comment and meetings.
``(3) Committee recommendations.--In issuing regulations
under this subsection, the Secretary shall consider the
recommendations of the Committee under subsection (c)(2).
``(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 following the development of the initial list
under that subsection.
``(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 regulations under subsection (d), the
Secretary may use up to 10 percent of the amount appropriated
under section 399OO-4(a) to engage in transitional subscription
contracts of up to 5 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 improved clinical outcomes. 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
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 characteristics of
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
establish within the Administration for Strategic Preparedness
and Response an office to 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 as Chair of the
Advisory Group a non-voting, independent member who may not be
a member represented under paragraph (2).
``(4) Conflicts of interest.--In appointing members under
paragraph (2) and a Chair under paragraph (3), 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, chapter 10 of title 5, United States Code,
(commonly known as the Federal Advisory Committee Act) shall
apply to the Advisory Group.
``SEC. 399OO-1. DESIGNATION OF ANTIMICROBIAL DRUG AS CRITICAL NEED
ANTIMICROBIAL DRUG.
``(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.--Not earlier than 2 years after a
designation approval or denial under paragraph (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 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, or a plan to coordinate
development of diagnostic tools as necessary;
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).
``SEC. 399OO-2. ESTABLISHMENT OF SUBSCRIPTION CONTRACT OFFICE;
SUBSCRIPTION CONTRACTS.
``(a) Subscription Contract Office.--
``(1) In general.--Not later than 180 days after the date
of enactment of this part, the Secretary shall establish within
the Administration for Strategic Preparedness and Response an
office, to be known as the `Subscription Contract Office', the
head of which shall be the Director (referred to in this
section as the `Director').
``(2) Purpose.--The purpose of the Office established under
paragraph (1) shall be to manage the establishment and payment
of subscription contracts awarded under this section, including
eligibility, requirements, and contract amounts.
``(b) 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
399OO-1 may submit an application for a subscription contract
to the Director, under a procedure established by the Director.
``(2) Review of applications.--The Director, in
consultation with the Committee, shall--
``(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 drug covered by the application
meets the favored characteristics identified under
section 399OO(c)(2); and
``(C) deny any application for a drug that does not
meet the minimum number and kind of favored
characteristics needed for the drug to be designated as
a critical need antimicrobial based on the regulations
issue under section 399OO(d).
``(c) Requirements.--As a condition of entering into a subscription
contract under this section, the sponsor of the critical need
antimicrobial drug covered by the application shall agree to--
``(1) ensure commercial 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, the Committee, the Administrator of the Food and
Drug Administration, and the Director of the 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 Director to ensure patient access to the drug;
``(9) abide by the manufacturing and environmental best
practices in the supply chain for the control of discharge of
antimicrobial active pharmaceutical ingredients to ensure
minimal discharge into, or contamination of, the environment by
antimicrobial agents or products as a result of the
manufacturing process; and
``(10) abide by such other terms as the Director may
require.
``(d) Monetary Value.--
``(1) In general.--The Director, in consultation with the
Committee, shall assign a monetary value to each subscription
contract under this section based on the regulations developed
under section 399OO(d).
``(2) Considerations.--In assigning a monetary value to a
subscription contract under paragraph (1), the Director shall
take into account the favored characteristic or combination of
favored characteristics of the drug covered by the contract, as
determined by the Director, in consultation with the Committee,
under subsection (b)(2)(B).
``(e) Amount of Contracts.--
``(1) In general.--A subscription contract under this
section shall be for the sale to the Secretary of any quantity
of the antimicrobial drug covered by the contract needed over
the term of the contract, at a price agreed on by the sponsor
and the Director, based on the monetary value assigned to the
contract under subsection (d).
``(2) Minimum and maximum amount.--The total projected
amount to be paid by the Director under a subscription contract
under this section shall be not less than $750,000,000 and not
more than $3,000,000,000, adjusted for inflation.
``(f) Term.--
``(1) Initial term.--The initial term of a subscription
contract under this section shall be--
``(A) not less than 5 years; and
``(B) not greater than the greater of--
``(i) 10 years; and
``(ii) 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'.
``(2) Effect.--A subscription contract shall remain in
effect for the period described in paragraph (1) even if the
infection treated by the antimicrobial drug covered by the
subscription contract is later removed from the list of
infections under section 399OO(c)(1).
``(3) Extension of contracts.--The Director 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 399OO-4(a).
``(4) Modification of contracts.--The Director 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).
``(g) Payments.--
``(1) In general.--Not later than 180 days after the date
on which a subscription contract is granted under subsection
(a), the Director shall provide payments for drugs purchased
under the contract in installments established by the Director,
in consultation with the sponsor of the antimicrobial drug and
in accordance with subsection (j).
``(2) Timing of payments.--The Director--
``(A) may make payments under paragraph (1) in
equal annual installments; and
``(B) shall not make such payments more frequently
than twice per year.
``(3) Option.--The sponsor shall have the option to receive
50 percent of the payment amount due in the last year of the
contract during the first year of the contract in order to
offset costs of establishing manufacturing capacity.
``(4) Funding.--Payments under this subsection shall be
allocated from the amount made available under section 399OO-
4(a).
``(5) 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.
``(h) Use of Contract Funds.--Funds received by the sponsor under a
subscription contract under this section shall be used--
``(1) to meet the requirements described in subsection (c);
and
``(2) to support the completion of postmarketing clinical
studies, manufacturing, other preclinical and clinical
activities, or other activities agreed to by the Director and
sponsor in the contract.
``(i) Contracts for Generic and Biosimilar Versions.--
Notwithstanding any other provision of this part, the Director 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 Director.
``(j) Antimicrobial Drug Sponsor Revenue Limitations.--
``(1) Requirement.--
``(A) In general.--With respect to a payment
installment under a subscription contract entered into
under this section, the net revenue from sales of the
applicable antimicrobial drug for beneficiaries or
enrollees in Federal health care programs during the
period covered by the payment installment shall be
subtracted from the payment installment.
``(B) Payment.--The amount calculated under
subparagraph (A) shall be paid by the Secretary to the
relevant Federal health care program (or its trust
fund) at the time of the applicable installment
payment.
``(C) Coordination.--The Director shall coordinate
with the relevant agencies of the Federal Government,
including the Centers for Medicare and Medicaid
Services, to carry out this subsection in a manner that
ensures minimal disruption to how a health care
provider currently acquires applicable antimicrobial
drugs.
``(2) Regulations.--
``(A) In general.--To carry out this subsection,
the Secretary shall promulgate regulations to identify
the Federal health care programs applicable under this
section, including Medicare part A and Medicaid, and to
establish the methodology and data collection
requirements necessary to calculate the amount under
paragraph (1)(A).
``(B) Methodology.--Any methodology established for
the collection of data and calculation of the amount
under paragraph (1)(A) shall take into account any
legally mandated or voluntary discounts and rebates
provided by the manufacturer of the applicable
antimicrobial drug to the Federal health care programs
that pay for such drug, on the condition that the
Secretary may presume that discounts not described in
subclauses (I) and (II) of subparagraph (C)(ii) are
captured in the price determined under subparagraph
(C)(i)(II).
``(C) Estimating annual net revenue.--
``(i) In general.--In determining the net
revenue from sales of the applicable
antimicrobial drug for beneficiaries or
enrollees in Federal health care programs for
the purpose of calculating the amount under
paragraph (1)(A), the Secretary shall determine
such net revenue amount by multiplying--
``(I) the total number of billing
units of such antimicrobial drugs
reported under the process described in
subparagraph (D)(ii) for the applicable
payment installment period; by
``(II) the average sales price (as
defined in section 1847A(c) of the
Social Security Act), the average
manufacturer price (as defined in
section 1927(k)(1) of the Social
Security Act), or another pricing
metric used in Federal health care
programs, for such antimicrobial drugs.
``(ii) Requirement.--The Secretary shall
adjust the amount determined under clause
(i)(II) to account for--
``(I) rebates, discounts, add-on
payments, or other adjustments provided
under--
``(aa) section 340B; or
``(bb) section 1927 of the
Social Security Act; or
``(II) negotiated price concessions
described in section 1860D-2(d)(1)(B)
of the Social Security Act that are not
captured in the applicable price.
``(D) Coding.--
``(i) In general.--In promulgating
regulations under subparagraph (A), the
Secretary shall, as appropriate, establish and
assign codes, under existing or new coding
systems, to identify units of the applicable
antimicrobial drug for beneficiaries or
enrollees in Federal health care programs.
``(ii) Coding use requirements.--In
promulgating regulations under subparagraph
(A), the Secretary shall require hospitals (or
other providers or suppliers) that administer
applicable antimicrobial drugs in the inpatient
or outpatient setting to report on their claims
to such Federal health care programs the
billing units of such antimicrobial drugs used
in the care of beneficiaries or enrollees in
each Federal health care program, regardless of
whether payment for those units are separately
reimbursed.
``(3) 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) Federal health care program.--The term
`Federal health care program' has the meaning given
such term in section 1128B(f) of the Social Security
Act, except that, for purposes of this subsection, such
term includes the health insurance program under
chapter 89 of title 5, United States Code.
``(k) 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 the requirements described in
subsection (c); or
``(C) does not complete a postmarket study required
by the Food and Drug Administration during 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 government
programs that pay for drugs subject to a contract agreement
entered into pursuant to this section for a year exceeds the
amount of the subscription contract paid by the Secretary for
that year.
``(l) 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.
``(m) Effect.--Nothing in this section permits the Secretary to use
evidence from comparative clinical effectiveness research in a manner
that treats extending the life of an elderly, disabled, or terminally
ill individual as of lower value than extending the life of an
individual who is younger, nondisabled, or not terminally ill in
determining the value of an antimicrobial drug or a subscription
contract (or a transitional subscription contract), including in such a
way that would limit patient access.
``SEC. 399OO-3. ENCOURAGING APPROPRIATE USE OF ANTIMICROBIALS AND
COMBATING RESISTANCE.
``(a) Establishment of Health Facility Grant Program.--
``(1) In general.--Not later than 1 year after the date of
enactment of this part, the Secretary shall establish a grant
program under the Centers for Disease Control and Prevention to
support hospital, skilled nursing facility, and other health
care 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 prevention
efforts, 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 health care facilities
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.
``(b) Surveillance and Reporting of Antimicrobial 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 trends in
antimicrobial resistance and antibiotic and antifungal use,
such as--
``(A) appropriate conditions and measures causally
related to antimicrobial resistance, including types of
infections, the source or body sites of infections, the
demographic information of patients with infections,
and infection onset in a community or hospital setting,
increased lengths of hospital stay, increased costs,
and rates of mortality; and
``(B) changes in bacterial and fungal resistance to
antimicrobial drugs, including changes in percent
resistance, prevalence of antimicrobial-resistant
infections, rates of mortality, and other such changes.
``(2) Antimicrobial use data.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall obtain reliable and comparable human
antibiotic and antifungal drug consumption data (including, as
available and appropriate, volume antimicrobial distribution
data and antibiotic and antifungal use data, including
prescription data) by State or metropolitan areas. To
accomplish this, the Centers for Disease Control and Prevention
may work with, as appropriate, Federal departments and 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.
``(3) Antimicrobial resistance trend data.--The Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, shall intensify and expand efforts to collect
antimicrobial 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.--Beginning on the date
that is 2 years after the date of enactment of this part, 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 antimicrobial
use and resistance, and, as appropriate, patient outcomes in
relation to antimicrobial resistance--
``(A) make the data described under this subsection
publicly available through reports and web updates
issued on a regular basis that is not less than
annually; and
``(B) examine opportunities to make such data
available in near real time.
``(c) Publication of Clinical Guidelines.--Not later than 1 year
after the date the Secretary makes the first designation under section
399OO-1(a), and not less than every 3 years thereafter, the Secretary
shall publish at least one update to clinical guidelines in
consultation with relevant professional societies. As appropriate,
guideline updates shall include each antimicrobial drug that has been
approved under section 505(c) of the Federal Food, Drug, and Cosmetic
Act or licensed under section 351(a) and that has been designated under
section 399OO-1(a), which guidelines shall set forth the evidence-based
recommendations for prescribing the drug for the relevant infection
time, in accordance with the available evidence after consultation
under section 399OO-1(c)(2), as appropriate.
``(d) Funding.--The Secretary may use not more than 5 percent of
the amounts appropriated under section 399OO-4(a) to carry out this
section.
``SEC. 399OO-4. 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, $6,000,000,000 for fiscal year 2024, 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. 399OO-5. 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 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. 399OO-6. 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, or
acts on the substances produced by such
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(a).''.
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