1.This Act may be cited as the
Strategies to Address Antimicrobial
Resistance Act
.
2.The Congress finds as follows:
(1)The advent of the
antibiotic era has saved millions of lives and allowed for incredible medical
progress; however, the increased use and overuse of antimicrobial drugs have
correlated with increased rates of antimicrobial resistance.
(2)Through mutation
as well as other mechanisms, bacteria and other infectious disease-causing
organisms—viruses, fungi, and parasites—develop resistance to antimicrobial
drugs over time. The more antimicrobial drugs are used, whether appropriately
or inappropriately, the more this contributes to the development of
antimicrobial resistance.
(3)The recent 2009
Influenza A: H1N1 virus (also known as Swine Flu Virus
) outbreak
clearly illustrates why infectious diseases experts are concerned about drug
resistance; although the H1N1 virus currently appears to be treatable by two
classes of available antiviral drugs, it is resistant to other classes, and
should the virus mutate and become resistant to all classes, which is possible,
we would be left extremely vulnerable.
(4)Scientific evidence suggests that the
development of antimicrobial resistance in humans is not due only to use of
antimicrobial drugs in humans, but also may be caused by the use of
antimicrobial drugs in food-producing animals.
(5)A study estimates that in 2005 more than
94,000 invasive methicillin-resistant Staphylococcus aureus (MRSA) infections
occurred in the United States and more than 18,500 of these infections resulted
in death—7 times more than a decade earlier.
(6)The recent 2009
Influenza A: H1N1 virus outbreak exacerbates concerns about MRSA and other
bacteria that cause respiratory diseases given that, during the 1918 influenza
pandemic, many thousands of deaths were caused by complications due to
secondary bacterial infections and not by the influenza virus itself.
(7)Each year, nearly
2,000,000 people contract bacterial infections in hospitals and approximately
90,000 of these people die from these infections.
(8)The current annual costs of
antimicrobial-resistant bacterial diseases are hard to quantify, but a 1995
report by the Office of Technology Assessment, an agency of Congress, which
looked at 6 different antimicrobial-resistant strains of bacteria, calculated
that the minimum nationwide hospital costs of just these strains of bacteria
accounted for $1,300,000,000 annually in 1992 dollars ($1,870,000,000 in 2006
dollars).
(9)A
1998 Institute of Medicine report estimated the societal cost of resistance as
between $4,000,000,000 to $5,000,000,000; many experts argue the cost in 2009
may be close to 10 times greater.
(10)The costs of
antimicrobial-resistant infections in terms of lives lost and economically will
only rise as antimicrobial resistance continues to spread.
3.Antimicrobial
Resistance Task Force
(a)Section 319E of the
Public Health Service Act (42 U.S.C. 247d–5) is amended—
(1)in subsection
(a)—
(A)in the subsection heading, by striking
Task
force
and inserting the following:
Antimicrobial Resistance
Office, Task force, and Advisory Board
;
(B)in paragraph
(1)—
(i)by
striking as of the date of the enactment of this section
and
inserting as of September 30, 2006
; and
(ii)by
adding at the end the following: The Secretary shall, not later than 1
year after the date of enactment of the Strategies to Address Antimicrobial Resistance
Act, establish an Antimicrobial Resistance Office in the Office
of the Secretary and appoint a director to that Office. The Secretary shall,
not later than 1 year after the date of enactment of such Act, establish the
Public Health Antimicrobial Advisory Board as an advisory board to the Director
of the Antimicrobial Resistance Office. The Director of the Antimicrobial
Resistance Office shall serve as the Director of the task force. To avoid
duplication and ensure that Federal resources are used efficiently and
effectively, the Director shall work in conjunction with the Federal agencies
represented on the Task Force to coordinate all antimicrobial resistance
activities undertaken and supported by the Federal Government, including the
activities and budgetary allocations of the Office, task force, and Public
Health Antimicrobial Advisory Board.
;
(C)by amending paragraph (2) to read as
follows:
(2)
(A)Members of the
Antimicrobial Resistance Task ForceThe task force described in paragraph (1)
shall be composed of representatives of such Federal agencies as the Secretary
determines necessary, including representation of the following:
(i)The Antimicrobial Resistance Office.
(ii)The Assistant
Secretary of Preparedness and Response.
(iii)The Centers for
Disease Control and Prevention.
(iv)The Food and Drug
Administration.
(v)The National
Institutes of Health.
(vi)The Agency for
Healthcare Research and Quality.
(vii)The Centers for
Medicare & Medicaid Services.
(viii)The Health
Resources and Services Administration.
(ix)The Department of
Agriculture.
(x)The Department of
Education.
(xi)The Department of
Defense.
(xii)The Department
of Veterans Affairs.
(xiii)The
Environmental Protection Agency.
(xiv)The Department
of Homeland Security.
(xv)The United States
Agency for International Development.
(B)Members of the
public health antimicrobial advisory board
(i)The Public Health
Antimicrobial Advisory Board shall be composed of 19 voting members, appointed
by the Secretary. Such members shall include experts from the medical
professions (including hospital and community-based physicians), pharmacy,
public health, veterinary, research, and international health communities, as
well as one representative from a public interest group.
(ii)Each
member appointed under clause (i) shall be appointed for a term of 3 years,
except that of the 19 members first appointed—
(I)6 shall be
appointed for a term of 12 months; and
(II)6 shall be
appointed for a term of 2 years.
(iii)The
Secretary shall appoint a Chair of the Public Health Antimicrobial Advisory
Board from among its members to lead and supervise the activities of the
Advisory Board.
(iv)Disclosure of
financial interestsPrior to a meeting of the Public Health
Antimicrobial Advisory Board, each member of the Advisory Board shall disclose
to the Secretary any potential, relevant financial interests as defined under
section 208(a) of title 18, United States
Code.
;
(D)in paragraph
(3)(B), by striking in consultation with the task force described in
paragraph (1) and
and inserting acting through the Director of
the Antimicrobial Resistance Office and the Director of the Centers for Disease
Control and Prevention, and in consultation with
; and
(E)by amending
paragraph (4) to read as follows:
(4)
(A)Antimicrobial
Resistance Office resistance dutiesThe Director of the Antimicrobial
Resistance Office, working in conjunction with the Federal agencies that are
represented on the task force described in paragraph (1), shall issue an update
to the Public Health Action Plan to Combat Antimicrobial Resistance within 18
months of the establishment of the Office and biennial updates thereafter. The
updates shall include enhanced plans for addressing antimicrobial resistance in
the United States and internationally. The Director of the Office shall post on
a website these updates as well as summaries of all non-proprietary data the
Task Force makes available. The Director of the Antimicrobial Resistance Office
shall work in conjunction with the Federal agencies that are represented on the
task force described in paragraph (1), and in consultation with the Public
Health Antimicrobial Advisory Board, to—
(i)establish
benchmarks for achieving the goals set forth in the action plan;
(ii)assess the
ongoing, observed patterns of emergence of antimicrobial resistance, and their
impact on clinical outcomes in terms of how patients feel, function, or
survive;
(iii)assess how
antimicrobial products are being used in humans, animals, and plants, and the
impact of such use in furthering the development of resistance and the
implications thereof for patient safety and public health;
(iv)establish a
priority list of human infectious diseases with the greatest need for
development of new point-of-care and other diagnostics, antimicrobial drugs,
and vaccines, and in particular serious and life-threatening bacterial
diseases, for which there are few or no diagnostic or treatment options;
(v)recommend basic,
clinical, epidemiological, prevention, and translational research where
additional federally supported studies may be beneficial;
(vi)recommend how to support antimicrobial
development through Food and Drug Administration activities, including through
the agency’s Critical Path Initiative;
(vii)recommend how
best to strengthen and link antimicrobial resistance-related surveillance and
prevention and control activities; and
(viii)collaborate with the Assistant Secretary
for Preparedness and Response to ensure that strategies to address
antimicrobial-resistance are coordinated with initiatives aimed at pandemic
influenza, including the 2009 Influenza A: H1N1 virus and H1N1 Avian Influenza
virus, severe acute respiratory syndrome, bioterrorism, and other emerging
health threats.
(B)Antimicrobial
resistance task force meetings and duties
(i)The
Antimicrobial Resistance Task Force shall convene periodically as the Director
of the Antimicrobial Resistance Task Force determines to be appropriate, but
not fewer than twice a year, to consider issues relating to antimicrobial
resistance.
(ii)Public health
action planAt least twice a year, the task force described in
paragraph (1) shall have a meeting to review, discuss, and further develop the
Public Health Action Plan to Combat Antimicrobial Resistance issued by the
interagency task force on antimicrobial resistance in 2001. Among other issues,
the task force may discuss and review, based on current need or concern—
(I)antimicrobial
clinical susceptibility concentrations proposed, established, or updated by the
Food and Drug Administration;
(II)data obtained by
government agencies and, as possible, by private sources on emerging
antimicrobial resistance related to clinical outcomes in terms of how patients
function, feel, or survive as well as data related to how antimicrobial drugs
may have been used inappropriately;
(III)surveillance data
and prevention and control activities regarding emerging antimicrobial
resistance from reliable sources including the Centers for Disease Control and
Prevention, the Food and Drug Administration, the Department of Defense, the
Department of Veterans Affairs, the Department of Agriculture, the
Environmental Protection Agency, and as feasible from private sources and
international bodies;
(IV)data on the
amount of antimicrobial products used in humans, animals, and plants from
reliable sources including data from the Centers for Disease Control and
Prevention, the Food and Drug Administration, the Environmental Protection
Agency, the Department of Veterans Affairs, the Centers for Medicare &
Medicaid Services, the Department of Homeland Security, and the Department of
Agriculture, and as feasible from private sources and international
bodies;
(V)the impact of antimicrobial resistance on
human health resulting from the approval of antimicrobial drugs for use in
humans or animals (including consideration of and recommendations on potential
management plans to limit and reduce the negative impacts of such resistance on
human health);
(VI)reports of
federally supported antimicrobial resistance research and antimicrobial drug
development research activities (including clinical, epidemiological,
prevention, and translational research) obtained from Federal agencies, as well
as reports of research sponsored by other countries, industry, and
non-governmental organizations;
(VII)reports on
efforts by the Food and Drug Administration to develop policies and guidances
which encourage antimicrobial drug development and appropriate use while
maintaining high standards for safety and effectiveness;
(VIII)health plan
employer data and information set (HEDIS) measures pertaining to appropriate
use of antimicrobial drugs; and
(IX)other data and
issues the task force described in paragraph (1) identifies as relevant to the
issue of antimicrobial resistance.
(iii)The Food and
Drug Administration may consult with the Director of the Antimicrobial
Resistance Office concerning the pending application of any antimicrobial drug
application submitted to the Secretary under section 505 or 512 of the Federal
Food, Drug, and Cosmetic Act or the Public Health Service Act.
(C)Public health
antimicrobial advisory board meetings and duties
(i)The Public Health Antimicrobial Advisory
Board shall meet as the Chair of the Public Health Antimicrobial Advisory Board
determines to be appropriate, preferably in conjunction with meetings of the
Antimicrobial Resistance Task Force, but not fewer than 2 times each
year.
(ii)The Public Health Antimicrobial Advisory
Board shall make recommendations to the Secretary, and the Antimicrobial
Resistance Office, regarding—
(I)ways to encourage
the availability of an adequate supply of safe and effective antimicrobial
products;
(II)research
priorities and other measures (such as antimicrobial drug resistance management
plans) to enhance the safety and efficacy of antimicrobial products;
(III)how best to
implement and update the goals of the Public Health Action Plan to Combat
Antimicrobial Resistance;
(IV)incentives
necessary to establish uniform mechanisms and data sets for State and local
reporting of resistance data;
(V)the adequacy of
existing surveillance systems to collect antimicrobial resistance data and how
best to improve the collection, reporting, and analysis of such data;
(VI)the development
of a national plan for the collection and analysis of isolates of resistant
pathogens, including establishing priorities as to which isolates should be
collected;
(VII)the implementation
and evaluation of interventions to promote appropriate antimicrobial drug use
in both inpatient and outpatient settings; and
(VIII)areas for
government, nongovernment, and international cooperation to strengthen
implementation of the Public Health Action Plan to Combat Antimicrobial
Resistance.
(D)Availability of
informationThe Antimicrobial
Resistance Office shall ensure that all information shall be made available to
the public on the website described in subparagraph (A) consistent with section
8 of the Strategies to Address Antimicrobial
Resistance
Act.
;
(2)by amending
subsection (b) to read as follows:
(b)Antimicrobial
resistance strategic research planThe Secretary, acting through the Director
of the Antimicrobial Resistance Office, the Director of the Centers for Disease
Control and Prevention, and the Director of the National Institutes of Health,
and in consultation with other Federal agencies and the Public Health
Antimicrobial Advisory Board, shall develop an antimicrobial resistance
strategic research plan that strengthens existing epidemiological,
interventional, clinical, behavioral, translational, and basic research efforts
to advance the understanding of—
(1)the development,
implementation, and efficacy of interventions to prevent and control the
emergence and transmission of antimicrobial resistance;
(2)how best to
optimize antimicrobial effectiveness while limiting the emergence of
resistance, including addressing issues related to duration of therapy,
effectiveness of therapy in self-resolving diseases, and determining
populations most likely to benefit from antimicrobial drugs;
(3)the extent to
which the use of antimicrobial products in humans, animals, plants, and other
uses accelerates development and transmission of antimicrobial
resistance;
(4)the natural
histories of infectious diseases (including defining the disease, diagnosis,
severity, and the time course of illness);
(5)the development of
new therapeutics, including antimicrobial drugs, biologics, and devices against
resistant pathogens, and in particular diseases for which few or no
therapeutics are in development;
(6)the development
and testing of medical diagnostics to identify patients with infectious disease
and identify the exact cause of infectious diseases syndromes, particularly
with respect to the detection of pathogens resistant to antimicrobial
drugs;
(7)the epidemiology,
pathogenesis, mechanisms, and genetics of antimicrobial resistance; and
(8)the sequencing of
the genomes, or other DNA analysis, or other comparative analysis of priority
pathogens (as determined by the Public Health Antimicrobial Advisory Board), in
collaboration with the Department of Defense and the Joint Genome Institute of
the Department of
Energy.
;
(3)in
subsection (c)—
(A)by inserting
acting through the Director of the Antimicrobial Resistance
Office,
after The Secretary,
; and
(B)by striking
members of the task force described in subsection (a),
;
(4)in subsection
(d)(1), by inserting , through the Antimicrobial Resistance
Office,
after The Secretary
; and
(5)in subsection
(e)—
(A)in paragraph (1), by
inserting , acting through the Director of the Antimicrobial Resistance
Office,
after The Secretary
;
(B)in paragraph (3),
by inserting , acting through the Antimicrobial Resistance
Office,
after The Secretary
; and
(C)by adding at the
end the following:
(4)Preference in
making awardsIn making awards under paragraph (1), the Secretary
shall give preference to eligible entities that will use grant funds to
establish demonstration projects to assess the scope of the antimicrobial
resistance problem and the level of appropriate and inappropriate use of
antimicrobial drugs especially related to self-resolving infections, including
the validation of models that may lead to the development of quality measures
for health care providers prescribing antimicrobial
drugs.
.
(b)Ensure access to
antimicrobial data and researchThe Director of the Antimicrobial
Resistance Office shall work with the agencies represented on the Antimicrobial
Resistance Task Force to identify relevant data and formats, and mechanisms for
communicating such data to the Antimicrobial Resistance Office and
Antimicrobial Resistance Task Force and, in a manner consistent with section 8
of this Act, with the Public Health Antimicrobial Advisory Board and the
public, including relevant data obtained by the agencies through contracts with
other organizations, including—
(1)use and clinical
outcomes data on patients receiving antimicrobial drugs for the treatment,
prevention, or diagnosis of infection or infectious diseases;
(2)surveillance data
regarding emerging antimicrobial drug resistance;
(3)susceptibility
data related to antimicrobial drug use;
(4)data related to the
amount of antimicrobial products used in humans, animals, and plants;
(5)data from
federally funded research intended to support antimicrobial drug
development;
(6)data demonstrating
the impact of research, surveillance, and prevention and control initiatives in
understanding and controlling antimicrobial resistance; and
(7)data regarding
implementation and evaluation of interventions to improve antimicrobial drug
prescribing practices.
4.Collection of
antimicrobial drug data
(a)Submission of
human and animal drug distribution dataChapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 512 the following:
512A.Submission of
human and animal drug distribution data
(a)Notwithstanding any
other provision of law, the Secretary shall require that each sponsor of a
human antimicrobial drug product which is approved under section 505 (including
section 505(j)) and sold or distributed in the United States, submit
antimicrobial drug sales and distribution data. Such data shall be—
(1)submitted not later than 60 days after the
beginning of the subsequent calendar year;
(2)reported on the calendar year and
segregated by month;
(3)in such format, and utilize any such unit
of measure, as the Secretary by regulation deems necessary and appropriate to
ensure the reported data is comparable and reliable; and
(4)made available to the Antimicrobial
Resistance Office and the Antimicrobial Resistance Task Force.
(b)To protect proprietary commercial
information, officials who serve in the Antimicrobial Resistance Office and on
the Antimicrobial Resistance Task Force shall sign a confidentiality agreement
prior to reviewing any such data to which access is granted under subsection
(a)(4).
.
(b)Submission of
Animal Sales and Distribution DataSection 512(l)(3) (21 U.S.C. 360b(l)(3)) is
amended—
(1)in subparagraph (C)—
(A)in clause (ii), by
deleting and
at the end;
(B)in clause (iii),
by striking the period at the end and inserting ; and
;
and
(C)by adding at the
end the following:
(iv)contain any such additional information, be
in such format, and utilize any such unit of measure as the Secretary by
regulation deems necessary and appropriate to ensure the reported data is
comparable and reliable.
;
and
(2)in subparagraph
(D), by striking may
and inserting shall
.
(c)Data from
additional sources
(1)The Secretary, acting
through the Director of the Antimicrobial Resistance Office, shall explore
opportunities to secure from private vendors and health care organizations
reliable and comparable animal and human antimicrobial drug consumption data
(volume antimicrobial distribution data and antimicrobial use, including
prescription data) by State or metropolitan area, as necessary, to supplement
the antimicrobial drug consumption data to be collected under this section for
the purpose of demonstrating how the consumption of antimicrobial drugs for
human and animal uses may affect the development of resistance over time and
within geographic locations and to institute preventive interventions.
(2)The Director of the Antimicrobial
Resistance Office may enter into negotiations with private vendors and health
care organizations to determine acceptable scope and parameters for summaries
of antimicrobial drug consumption data that is collected under this section
publicly available for research purposes.
(3)Other means to
secure dataIf the Director
of the Antimicrobial Resistance Office is not able to secure sufficient
supplemental antimicrobial drug consumption data for human and animal uses
through private vendors and health care organizations as provided for in this
section, the Secretary shall consider other means to secure such consumption
data, including through the conduct of surveys about how antimicrobial drugs
are used in various settings.
(d)Collection of
antimicrobial prescription data
(1)The Director of
the Antimicrobial Resistance Office, the Under Secretary for Health of the
Department of Veterans Affairs, and the Administrator of the Centers for
Medicare & Medicaid Services shall work together to collect and analyze
relevant drug utilization data and clinical outcomes data, as determined
relevant by the Director of the Antimicrobial Resistance Office, on patients
who receive services funded by such agencies and who are receiving prescription
antimicrobial agents for the treatment or prevention of infection or infectious
diseases.
(2)Any
data collected under paragraph (1) shall be organized by—
(A)indication
(including results of diagnostic studies when available);
(B)dosage;
(C)route of
administration;
(D)duration;
(E)age of the
patient; and
(F)geographic
region.
(3)Interventions
and analysisThe Under Secretary for Health of the Department of
Veterans Affairs, the Administrator of the Centers for Medicare & Medicaid
Services, and the Director of the Antimicrobial Resistance Office shall work
together to identify and report upon interventions that prevent and control the
development of antimicrobial resistance and to include within such reports,
where appropriate, an analysis of the following—
(A)intra- and
extra-label antimicrobial use;
(B)where challenges
to appropriate use remain;
(C)trends and
variations in antimicrobial resistance rates; and
(D)the relationship
between drug use and resistance.
(e)Public
Availability of DataThe Director of the Antimicrobial Resistance
Office shall make summaries of the data received under this section publicly
available and ensure that such summaries are updated and published, in a manner
consistent with section 8, at least once annually on the website described in
section 319E(a)(4)(A) of the Public Health Service Act (42 U.S.C.
247d–5(a)(4)(A)) in order to support epidemiologic and microbiologic
research.
5.Antimicrobial
Resistance Surveillance and Research Network
(a)The Secretary,
through the Director of the Centers for Disease Control and Prevention and the
Director of the National Institutes of Health, shall establish at least 10
Antimicrobial Resistance Surveillance and Research Network sites to strengthen
the national capacity to—
(1)describe and confirm regional outbreaks
through surveillance of locally available clinical specimens;
(2)assess, integrate, and address local and
national antimicrobial resistance patterns;
(3)facilitate research on prevention, control,
and treatment of resistant organisms; and
(4)serve as a clinical trials network for
optimizing antimicrobial drug effectiveness.
(b)The sites
established under subsection (a) shall be geographically distributed across the
United States.
(c)Nonduplication
of current national capacityThe sites established under subsection (a)
may be based in academic centers, health departments, and existing surveillance
sites.
(d)The Network of sites established under
subsection (a) shall—
(1)monitor the emergence and changes in the
patterns of antimicrobial resistant pathogens in individuals;
(2)study the molecular epidemiology of such
pathogens;
(3)evaluate the efficacy of new and existing
interventions to prevent or limit the emergence of antimicrobial resistance
throughout the geographic region of the site;
(4)provide to the Centers for Disease Control
and Prevention isolates of resistant pathogens, and in particular, pathogens
that show new or atypical patterns of resistance adversely affecting public
health;
(5)conduct clinical research to develop
natural histories of infectious disease and to study duration of antimicrobial
use related to resistance development, among other things;
(6)assess the feasibility, cost-effectiveness,
and appropriateness of surveillance and screening programs in differing health
care and institutional settings, such as schools; and
(7)evaluate current treatment protocols and
make appropriate recommendations on best practices for treating drug resistant
infections.
(e)The sites established under subsection (a)
shall share data and cooperate with the Centers for Disease Control and
Prevention and the National Institutes of Health.
(f)The Director of the
Centers for Disease Control and Prevention and the Director of the National
Institutes of Health shall ensure that summary reports of data obtained by the
Antimicrobial Resistance Surveillance and Research Network sites are made
available to the Antimicrobial Resistance Task Force and, in a manner
consistent with section 8 of this Act, with the Public Health Antimicrobial
Advisory Board and the public, for review on an ongoing basis .
6.Section 319E(f) of
the Public Health Service Act (42 U.S.C. 247d–5(f)) is amended to read as
follows:
(f)Funds appropriated
under this section shall be used to supplement and not supplant other Federal,
State, and local public funds provided for activities under this section,
including funds appropriated for the Centers for Disease Control and Prevention
and the National Institutes of
Health.
.
7.Authorization of
appropriationsSection 319E(g)
of the Public Health Service Act (42 U.S.C. 247d–5(g)) is amended to read as
follows:
(g)Authorization of
appropriations
(1)There
are authorized to be appropriated to carry out this section (other than
subsection (b)) $45,000,000 for fiscal year 2010, $65,000,000 for fiscal year
2011, and $120,000,000 for fiscal years 2012 through 2014.
(2)Of the amount appropriated to carry out
this section for a fiscal year, not less than one-third of such amount shall be
made available for activities of the Centers for Disease Control and Prevention
under subsections (a)(3)(B) and (c), of which an appropriate amount shall be
allocated to educational programs under subsection (c) dedicated to the
reduction of inappropriate antimicrobial
use.
.
8.Protection of
confidential and national security informationExcept as otherwise required by law, this
Act (and the amendments made by this Act) shall not permit public disclosure of
trade secrets, confidential commercial information, or material inconsistent
with national security that is obtained by any person under this Act.