[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8920 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 8920
To establish a program to develop antimicrobial innovations targeting
the most challenging pathogens and most threatening infections.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 9, 2020
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, Homeland
Security, and Natural Resources, 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 2020'' or ``The
PASTEUR Act''.
SEC. 2. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION MODEL; ADVISORY GROUP.
(a) In General.--Not later than 60 days after the date of enactment
of this Act, 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 prioritized infections for which new
antimicrobial drug development is needed, taking into account
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. 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 Act 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 4. 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 drug that treats certain
multi-drug resistant infections, and, to a lesser
extent, second and third drugs that treat such
infections;
(D) addressing an infection located in an organ or
other location that is challenging to treat;
(E) addressing a multi-drug resistant infection
through a novel chemical scaffold or mechanism of
action, especially through oral administration;
(F) having received a transitional subscription
contract under subsection (f); and
(G) 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 3;
(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 Act.
(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, and shall finalize and publish the regulations 60
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 Act, 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 4, 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.
(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 Act 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 6(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 (21 U.S.C. 355f(g))), similarly
innovative biologic antimicrobial drugs, or innovative drugs
that achieve an antimicrobial outcome through immunomodulation.
Funds made available under such contracts may be used for a
variety of purposes including to support the 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 demonstrates a significant
clinical advancement in treating an infection
for which there is an unmet clinical need, an
anticipated clinical need, or multidrug
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;
(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
Federal 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 (21 U.S.C. 355(c)) or licensed
under section 351(a) of the Public
Health Service Act (42 U.S.C. 262(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 30 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 Act, 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) 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 less 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 (5 U.S.C.
App.) shall apply to the Advisory Group.
SEC. 3. 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 (21 U.S.C. 355(b)) or section 351(a) of the Public Health
Service Act (42 U.S.C. 262(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) of
the Public Health Service Act, 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) of the Public Health Service Act.
(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 2(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 no
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 2(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 2(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 submit an
appropriate use plan to the Secretary within 90 days of
application approval for appropriate use of diagnostics for
consideration by the Secretary and Committee to develop
clinical guidelines. A diagnostic plan--
(A) shall include--
(i) the appropriate use of the drug; and
(ii) the appropriate use of diagnostic
tools 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 another entity.
(2) Consultation.--The Secretary shall work with relevant
professional societies and the Critical Need Antimicrobial
Advisory Group established under section 2(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 collaboration
with relevant professional societies with respect to each
antimicrobial drug designated under subsection (a) which 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. 4. 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 (21
U.S.C. 355(c)) or licensure under section 351(a) of the Public
Health Service Act (42 U.S.C. 262(a)), the sponsor of an
antimicrobial drug designated as a critical need antimicrobial
under section 3 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 2(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 2(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; and
(10) abide by other terms as the Secretary may require.
(c) Term and Amount 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 6(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 may be used to support criteria qualification under
subsection (b), the completion of postmarketing clinical
studies, manufacturing, and other preclinical and clinical
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 2(c)(1).
(B) Extension of contracts.--The Secretary may
extend subscription contracts beyond the initial
contract period with a generic or biosimilar brand
manufacturer of the antimicrobial drug receiving a
subscription contract or the original drug
manufacturer. 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 6.
(C) Modification of contracts.--The Secretary or
sponsor, every 2 years after the start of the contract
period under this subsection, may request a
modification of the amount of the contract based on
information that adjusts favored characteristics in
section 2(c)(2).
(3) Adjustment.--In the case of an antimicrobial drug that
received a transitional subscription contract under section
2(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 2(f) for such drug.
(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, 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 Secretary of Health and Human Services
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 (42 U.S.C.
1395w-101 et seq.), 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, 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.--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 (42 U.S.C. 1395j
et seq.), the product of--
(i) the per-unit average sales price (as
defined in section 1847A(c) of such Act (42
U.S.C. 1395w-3a(c))) 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.
(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 (42 U.S.C. 1395c et seq.), 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 (42
U.S.C. 1396a(a)(6)), the Secretary shall require each
State that makes medical assistance available under the
State Medicaid program 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 (42 U.S.C.
1396r-8)) to report to the Secretary, not later than
the date established under subparagraph (A), for each
dosage form and strength and package size of each such
drug dispensed during the preceding calendar year under
the State Medicaid program, the amount equal to--
(i) the product of--
(I) the per-unit ingredient cost
paid by the State for each such drug;
and
(II) the number of units of such
drug paid for under the State Medicaid
program; minus
(ii) any discounts or other price
concessions provided and rebates paid to the
State with respect to such drug and such
calendar year (including rebates paid under a
rebate agreement under section 1927 of such Act
(42 U.S.C. 1396r-8) 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, the product of--
(I) the per-unit ingredient cost,
minus any per-unit rebate paid by the
covered entity; 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) Guidance.--Not later than 1 year after the date of
enactment of this Act, the Secretary shall publish guidance to
assist the heads (or designees) of Federal agencies carrying
out specified government programs 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 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 (42
U.S.C. 1395w-101 et seq.);
(ii) the Medicare Part B program under part
B of such title XVIII (42 U.S.C. 1395j et
seq.);
(iii) the Medicare Part A program under
part A of such title XVIII (42 U.S.C. 1395c et
seq.);
(iv) the Medicaid program established under
title XIX of the Social Security Act (42 U.S.C.
1396 et seq.) 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 branded
prescription drugs are procured by the
Department of Defense;
(vii) the TRICARE retail pharmacy program
under section 1074g 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; or
(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.
(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 pull incentives that are similar to the subscription
contracts authorized under this section.
SEC. 5. 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 Act, 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 (42 U.S.C.
1395ww(d)(2))) 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 (42 U.S.C.
1395x(mm)(1))), hospitals serving Tribal-populations, and
safety-net hospitals.
(3) Funding.--Of the amounts appropriated under section 6,
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 resistance and use 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. 6. APPROPRIATIONS.
(a) In General.--To carry out this Act, there are hereby
appropriated to the Secretary, out of amounts in the Treasury not
otherwise appropriated, $11,000,000,000, for fiscal year 2021, 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 U.S.C. 933(g)).
(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. 7. STUDIES AND REPORTS.
(a) In General.--Not later than 6 years after the date of enactment
of this Act, the Comptroller General of the United States shall
complete a study on the effectiveness of this Act 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 Act 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) Reports on Antifungal Resistance and Antimicrobial
Prophylactics.--Not later than 3 years after the date of enactment of
this Act, the Director of the Centers for Disease Control and
Prevention shall publish--
(1) a report on antifungal resistance in the United States;
and
(2) a report on antimicrobial prophylactics.
SEC. 8. DEFINITIONS.
In this Act--
(1) the term ``antimicrobial drug''--
(A) subject to subparagraph (B), means--
(i) an antibiotic drug, as defined in
section 201(jj) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(jj)); or
(ii) a biological product, as defined in
section 351(i) of the Public Health Service Act
(42 U.S.C. 262(i)), that exhibits antimicrobial
activity; and
(B) excludes--
(i) any antifungal drug; and
(ii) any vaccine;
(2) the term ``Committee'' means the Committee on Critical
Need Antimicrobials established under section 2; and
(3) the term ``Secretary'' means the Secretary of Health
and Human Services.
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