[Congressional Record Volume 168, Number 158 (Thursday, September 29, 2022)]
[Senate]
[Pages S5583-S5587]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 6052. Mr. BENNET (for himself and Mr. Young) submitted an
amendment intended to be proposed to amendment SA 5499 submitted by Mr.
Reed (for himself and Mr. Inhofe) and intended to be proposed to the
bill H.R. 7900, to authorize appropriations for fiscal year 2023 for
military activities of the Department of Defense, for military
construction, and for defense activities of the Department of Energy,
to prescribe military personnel strengths for such fiscal year, and for
other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. 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 and patient types for
which new antimicrobial drug development is needed, taking
into account patient factors, 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
[[Page S5584]]
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 improve patient outcomes in treating
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 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 and patients on the list under
paragraph (1);
``(B) improving clinical and patient outcomes for patients
with multi-drug-resistant infections;
``(C) being a first-approved antimicrobial drug that 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 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) improving patient outcomes for an 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 399OO-1;
``(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
399OO-2, 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 and Patient Types.--The Secretary,
in collaboration with the Committee, shall update the list of
infections and patient types 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
399OO-4(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 improved clinical and patient outcomes 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 and improves patient
outcomes 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, patient outcomes, 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.
[[Page S5585]]
``SEC. 399O-1. 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, evidence of patient outcomes, 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 and demonstrating
improved infection diagnosis and benefit with the drug, 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 evidence in submissions of the
sponsor under paragraph (1) and after consultation under
paragraph (2), as appropriate.
``SEC. 399O-2. 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 399OO-1 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, patient outcomes, 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 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
``(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 characteristic or
combination of favored characteristics of the drug, including
improved patient outcomes, 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 399OO-4(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
[[Page S5586]]
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.
``(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) In general.--Pursuant to a contract entered into
under this section, during the term of such a contract, the
annual net revenue from sales of the applicable antimicrobial
drug for beneficiaries or enrollees in Federal health care
programs shall be subtracted from the annual payment
installments determined in the subscription contract. The
Secretary shall coordinate with the relevant agencies of the
Federal Government 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.--To carry out this subsection, the
Secretary shall promulgate regulations to identify the
Federal health care programs applicable under this section
and to establish the methodology and data collection
requirements necessary to determine the amount to be
subtracted from any contract. Any methodology established for
the collection of data and calculation of the amount to be
subtracted from any contract shall take into account any
legally mandated or voluntary discounts and rebates provided
by the manufacturer of the applicable antimicrobial drug to
the government programs that pay for such drugs subject to a
contract agreement entered into pursuant to subsection
(c)(2).
``(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.
``(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 government
programs that pay for drugs subject to a contract agreement
entered into pursuant to subsection (c)(2), 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. 399O-3. ENCOURAGING APPROPRIATE USE OF ANTIBIOTICS,
COMBATING RESISTANCE, AND IMPROVING PATIENT
OUTCOMES.
``(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 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, skilled nursing
facility, 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
patient outcomes; 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 or skilled
nursing 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.
``(3) Funding.--Of the amounts appropriated under section
399OO-4, the Secretary shall reserve $500,000,000 to carry
out this subsection.
``(b) Surveillance and Reporting of Antibiotic Use,
Resistance, and Patient Outcomes.--
``(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, patient outcomes, and
measures causally related to antibacterial resistance,
including types of infections, the causes for infections, the
types of patients with 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, rates of patient survival, patient symptoms and
function in their daily lives, 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 and patient outcomes
data.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall intensify
and expand efforts to collect antibiotic resistance and
patient outcomes 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. 399O-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
2023, 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
[[Page S5587]]
concurrent resolution on the budget for fiscal year 2018.
``SEC. 399O-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 and improving
patient outcomes. 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
patient outcomes 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. 399O-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 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.''.
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