### STATEMENT OF THE INFECTIOUS DISEASES SOCIETY OF AMERICA BEFORE THE FOOD AND DRUG ADMINISTRATION PART 15 HEARING PANEL ON ANTIMICROBIAL RESISTANCE 

APRIL 28, 2008

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###  Presented by:

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> John G. Bartlett, MD, FIDSA\
> Johns Hopkins University School of Medicine\
> Division of Infectious Diseases\
> Baltimore, Maryland
>
> Neil O. Fishman, MD
>
> University of Pennsylvania School of Medicine
>
> Philadelphia, Pennsylvania
>
> Robert J. Guidos, JD**\
> **Director, Public Policy & Government Relations\
> Infectious Diseases Society of America\
> Arlington, Virginia

### STATEMENT OF THE INFECTIOUS DISEASES SOCIETY OF AMERICA 

BEFORE THE FOOD AND DRUG ADMINISTRATION

PART 15 HEARING PANEL ON ANTIMICROBIAL RESISTANCE\
APRIL 28, 2008

### 

The Infectious Diseases Society of America (IDSA) appreciates the
opportunity to provide this statement before the U.S. Food and Drug
Administration's (FDA) Part 15 panel on the critically important issue
of antimicrobial resistance.

IDSA represents more than 8,000 infectious diseases physicians and
scientists devoted to patient care, education, research, prevention, and
public health. Our members care for patients of all ages with serious
and life-threatening infections, including meningitis, pneumonia,
tuberculosis, antimicrobial drug-resistant infections, and those with
cancer or transplants who have life-threatening infections caused by
unusual microorganisms, HIV/AIDS, and other emerging infections.

Antimicrobial resistance is a serious patient safety and burgeoning
public health problem. The resistant infections about which Infectious
Diseases specialists and other physicians are most concerned at this
time are caused by bacteria. For this reason, our statement will
primarily focus on antibacterial resistance. IDSA's statement includes a
discussion of the antibacterial resistance problem and why Infectious
Diseases and other physicians are concerned, the critical need for new
products to detect, treat and prevent resistant infections as well as 12
priority recommendations that require FDA's immediate consideration.

### Antibacterial-Resistant Infections: Why IDSA Is Concerned

Bacterial infections affect hundreds of thousands of Americans and cause
tens of thousands of deaths each year, perhaps more. Resistant
infections are painful, difficult to treat, and cost many billions of
dollars to the U.S. health care system annually. These "bad bugs" have
become a silent epidemic in communities and hospitals across the United
States as well as around the world. And yet, an astoundingly diminutive
amount of federal resources are being committed to address this
staggering problem. In fiscal year (FY) 2006, FDA spent only \$24
million on its collective antimicrobial resistance activities, the
Centers for Disease Control and Prevention (CDC) spent only \$17.2
million, and the National Institutes of Health (NIH) spent only \$220
million (\$194.5 million of which was spent at the National Institutes
of Allergy and Infectious Diseases (NIAID)---4.4% of NIAID's total
budget. \$90 million of NIAID's antimicrobial resistance research budget
was dedicated to antibacterial resistance research---2.1% of NIAID's
total budget).

The bacteria of greatest concern include multi-drug-resistant
*Staphylococcus aureus* (MRSA), resistant *Escherichia coli (E. coli),
Acinetobacter baumannii* (which is threatening soldiers returning from
Iraq and Afghanistan)*,* resistant *Klebsiella species* (which appear to
have originated in or near Brooklyn and now are spreading across the
East Coast and into the Midwest), extensively drug-resistant
tuberculosis (XDR-TB), *Clostridium difficile, Enterococcus faecium,
Enterobacter species,* and resistant *Pseudomonas aeruginosa.* There are
many others.

Although primarily affecting ill people in hospitals, a growing number
of the victims of drug-resistant bacteria, such as MRSA, are people in
the community and outside hospitals, including healthy athletes and
children. A recent study in the Journal of the American Medical
Association (October 17, 2007) demonstrates that more than 94,000 people
are infected and nearly 19,000 die annually from MRSA alone around the
country -- more deaths than those caused by emphysema, HIV/AIDS,
Parkinson's disease and homicide. New national surveillance data from
the CDC demonstrate that an incredible 80% of *E. faecium* associated
with device-related healthcare-associated infections (HAIs) were
resistant to vancomycin. More broadly, these new data demonstrate high
rates of antimicrobial resistance in the gram-negative pathogens
associated with device-related HAIs. Disturbingly, analysis of national
data indicated that twenty-six to thirty-seven percent of *A. baumannii*
were carbapenem-resistant, as was ten percent of

*K. pneumoniae.* Thirty percent of *P. aeruginosa* were resistant to
fluoroquinolones.

**Antibacterial Drug Portfolio: Why IDSA Is Concerned**

Of serious concern, Infectious Diseases physicians are alarmed by the
prospect that effective antibacterial drugs may not be available to
treat seriously ill patients in the near future. Since their discovery,
antibacterial drugs have dramatically reduced the morbidity and
mortality associated with bacterial diseases, saving millions of lives
and easing patients' suffering. However, over time, certain classes of
drugs are losing their effectiveness to increasingly resistant
infections. Until recently, the pharmaceutical industry's research and
development (R&D) efforts counteracted this phenomenon by developing new
drugs in time to treat bacteria that became resistant to older
antibacterial drugs. However, that is no longer the case. Unfortunately,
both the public and private sectors appear to have been lulled into a
false sense of security based on past successes.

The potential crisis at hand is the result of a marked decrease in
industry R&D, government inaction, and the increasing prevalence of
resistant bacteria. It takes 8 years to develop a new antibacterial
drug. Thus, today we should be planning for our pharmaceutical needs of
2012-2015. Given the state of the current pipeline, our future looks
bleak. To call attention to the resistance problem and the diminishing
pipeline, in 2004, IDSA launched its "Bad Bugs, No Drugs" advocacy
campaign by issuing a landmark report and several subsequent articles to
highlight the brewing patient safety and public health crisis.
([www.idsociety.org/badbugsnodrugs](http://www.idsociety.org/badbugsnodrugs)).

FDA has acknowledged there is problem in the antibacterial drug
pipeline. In the agency's March 2004 Critical Path report
"Innovation/Stagnation: Challenge and Opportunity on the Critical Path
to New Medical Products", the agency reported that "product development
in areas crucial to public health goals, such as antibiotics, has slowed
significantly during the past decade." However, since 2004, the agency
has dedicated insufficient time and resources to solve the resistance or
pipeline problems. In fact, if anything, the Agency's recent actions
have produced greater cause for worry as growing uncertainty about FDA's
anti-infective drug review process mounts.

It is frustrating to see patients with life-threatening infections and
the toll it takes on their lives and on their families and friends, or
to see children and adults die when we have the resources and the tools
to reduce the impact of these diseases. We cannot stop the development
of antibacterial resistance -- bacteria will continue to mutate in
response to antibacterial drug use. However, we can slow the pace of the
rise in antibacterial resistance, if we have the will to act.

**The Path Forward**

Antibacterial resistance and the diminishing antibacterial pipeline are
complex and multi-dimensional problems. Multi-pronged solutions are
required to sufficiently limit the impact of antibacterial resistance on
patients and the public and to spur the development of products to
address antibacterial resistant infections. Such efforts include:

-   removing disincentives in the antibacterial drug review process by
    reestablishing consistency, predictability and timeliness;

-   providing economic and other incentives to spur the development of
    new products in this area (e.g., antibacterial drugs, relevant
    diagnostic tests, and vaccines);

-   significantly strengthening federal research in new, relevant rapid
    diagnostics as a means to reduce the number of patients needed for
    antibacterial drug clinical trials;

-   creating an antimicrobial resistance strategic research plan that
    establishes priorities and significantly strengthens collaborations
    between FDA, NIH, CDC, the Departments of Agriculture, Veteran
    Affairs, Defense and the Environmental Protection Administration.

-   educating physicians, patients, and parents about the appropriate
    use of antibacterial drugs;

-   developing and applying infection control and immunization policies
    and practices to prevent transmission;

-   improving our collection of data regarding clinical, veterinary and
    human antibacterial use, and other data;

-   protecting antibiotics of importance to human health from being used
    in agriculture;

-   improving surveillance efforts to detect and monitor the emergence
    of resistance; and

-   developing safer alternatives to antibacterial drug uses in
    agriculture.

Implementing many of these solutions will require significant attention,
resources, and, in some cases, substantial political will to overcome
special interests in favor of public health and patient safety.

In 2001, the Administration recognized the gravity of the problem and
developed a federal "Action Plan to Combat Antimicrobial Resistance," an
effort led by CDC, FDA, and NIH. Unfortunately, very limited progress
has been made toward implementing the Action Plan's 13 Top Priority
Action Items, let alone the remainder of the 84 action items. Moreover,
in 2000, FDA's own Task Force on Antimicrobial Resistance issued a
report (<http://www.fda.gov/oc/antimicrobial/taskforce2000.html>)
containing nine (9) recommendations which, if implemented, could have
helped significantly to address the antimicrobial resistance problem.
Unfortunately, the Agency has made little progress toward implementing
these recommendations since 2000.

Below are twelve additional recommendations that IDSA believes will go
far toward addressing the antimicrobial resistance and pipeline
problems. Within these recommendations are several critical steps that
FDA can take immediately.

The United States Government, including FDA, can no longer take a
business-as-usual approach toward addressing the antimicrobial
resistance problem. Following today's Part 15 hearing, it is imperative
that the agency dedicate sufficient resources to implement the Action
Plan's recommendations, FDA's own recommendations from 2000 as well as
the additional recommendations that IDSA outlines below.

**IDSA's Twelve Recommendations For FDA's Immediate Consideration**

\[The following recommendations are not listed by priority ranking. They
are listed chronologically as they will be presented by IDSA's
presenters.\]

 

[**Recommendation \#** **1**]{.underline} **  *FDA Should Work
Aggressively To Re-Establish Consistency, Predictability, and Timeliness
In The Antibacterial Drug Review**** **Process.*** ** ** 

 

Significant uncertainty exists within the agency's antibacterial human
drug review process, which we fear is shaking the foundation of the
nation's antibacterial pharmaceutical industry. The agency must move
quickly to reestablish consistency, predictability, and timeliness to
this process which IDSA believes requires the attention and leadership
of the director of the Center for Drug Evaluation and Review as well as
an infusion of additional staff and resources. IDSA has heard from many
pharmaceutical industry representatives that FDA has lost credibility by
throwing out existing policies without having new policies available to
replace the old, rejecting prior agreements with companies, and
employing endless delays including in the issuance of clinical trial
guidances. Time delays are costing millions and threatening bankruptcy
for some companies. FDA must move rapidly to restore trust by making
public its plan to resolve internal disincentives to antibacterial drug
discovery and development.  The plan should include the agency's
priorities for action.

[**Recommendation \#** **2**]{.underline} ** ** ***FDA Should Strengthen
Critical Path And Other Research, Establish Research Priorities With
NIH, CDC, USDA, and Other Agencies And Collaborate More Often With These
Agencies On Antibacterial Resistance and Drug Pipeline-Supportive
Research.***

In 2000, FDA's Task Force on Antimicrobial Resistance reported "In
hearing about the efforts of multiple centers, it also became clear that
coordination of antimicrobial resistance research, both within FDA and
with sister government agencies and academia, is currently largely
informal." In IDSA's estimation, little has changed to formalize the
U.S. antimicrobial resistance research agenda and to establish and
publicize U.S. priorities. For this reason, in June 2007 IDSA proposed
the creation of an antimicrobial resistance strategic research plan to
strengthen existing epidemiological, interventional, clinical,
translational and basic research efforts in a letter to Drs. Anthony
Fauci, NIAID Director, and Julie Gerberding, CDC Director,
(<http://www.idsociety.org/WorkArea/showcontent.aspx?id=4642>). FDA has
a critical role to play in that effort, and we urge FDA, NIH, CDC, the
U.S. Department of Agriculture (USDA), and other relevant agencies to
move immediately to establish a Blue Ribbon Panel to establish U.S.
research priorities and create a strategic research plan.

Even without such a strategic plan, FDA should act now to support
research that can help lead to a reduction in the number of patients
necessary for antibacterial clinical trials.  Such research should
include validation of endpoints such as quality of life, length of stay,
duration of fever, time to elimination of pathogen, patient-reported
outcomes, etc. as well as the development of new, rapid diagnostics. The
agency should seek and strengthen collaborations with NIH, CDC, USDA and
other agencies on studies that will address resistance and support the
antibacterial drug pipeline. Finally, FDA should publish a summary of
the antimicrobial resistance/pipeline research efforts it currently has
underway under its Critical Path and other initiatives.

 

[**Recommendation \#** **3**]{.underline} **  *FDA Should Take Immediate
Action To Update Antibacterial Clinical Susceptibility
Concentrations.**** *

Physicians need accurate information on antibacterial clinical
susceptibility concentrations ("breakpoints") to use antibacterial drugs
wisely. Patients' safety and lives are on the line. Given a new
requirement included in the FDA Amendments Act, it is incumbent upon the
agency to establish workable processes for expeditiously updating
antibacterial breakpoints as well as to publish its methodology for
setting breakpoints.  FDA staff\'s recent inventory of antibacterial
labels has uncovered that out of the more than 100 currently approved
antibacterial labels more than 70 contain breakpoints that are
out-of-date.

Prior to 2006, FDA\'s Center for Devices and Radiological Health (CDRH)
allowed susceptibility test device manufacturers to include both
FDA-established breakpoints listed in package inserts at the time of the
drug's approval as well as the more up-to-date breakpoint recommended by
the Clinical Laboratory Standards Institute (CLSI) (formerly NCCLS).
CLSI, a 501(c)(3) non profit organization, is a recognized standard
setting body comprised of experts in infectious diseases and clinical
microbiology. CLSI is not affiliated with IDSA.  In 2006, FDA began to
require that CLSI submit citizen petitions to the agency when
recommending updated breakpoints. In IDSA's estimation, the new process
has been a failure as FDA has taken limited definitive action on the
five CLSI petitions submitted to date.

The agency should explore several options available to it for updating
breakpoints including:

-   establishing a less-cumbersome process for reviewing and accepting
    CLSI's recommendations;

-   creating FDA's own scientific board of external experts comprised
    of infectious diseases clinicians, microbiologists, pharmacologists,
    and others who understand the clinical impact of changes in the
    interpretations of the MIC.  The board could help the agency update
    breakpoints and/or review and approve breakpoints recommended by
    CLSI or other appropriate entities;

-   contracting out some of the activities needed to update breakpoints
    through organizations such as CLSI.  Infusing some of the agency\'s
    patient safety funding into CLSI\'s effort could help to more
    quickly address out-of-date breakpoints.

Specifically, IDSA urges FDA to:

-   review and update antibacterial drug breakpoints on a regular basis
    as clinical need dictates, but no less frequently than every 5 years

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-   return to purchasing from private vendors the critically needed
    susceptibility data used to update breakpoints;

-   require pharmaceutical sponsors (both pioneer and generic) to
    provide any such additional data as may be needed to update
    breakpoints quickly; and

-   immediately publish its methodology for setting breakpoints, which
    previously has not been made public.  IDSA members have heard
    statements from FDA officials that such methods are \"not written
    down anywhere\".  This is unacceptable and only helps to demonstrate
    the lack of attention and sufficient resources the agency has
    devoted to this critical patient safety responsibility over the last
    several decades.

[**Recommendation \#** **4**]{.underline} **  *FDA, Working With Other
Agencies Represented On The Interagency Task Force On Antimicrobial
Resistance, Should Establish A Public Health Antimicrobial Advisory
Board Of Outside Experts To Advise The Task Force In Its Efforts.***

Antimicrobial resistance is a complex, multi-dimensional problem.
Addressing the problem will require expertise from the infectious
diseases, medical (including hospital and community-based physicians),
veterinary, public health, research, pharmacoeconomic, and international
health communities. The private sector provides incredible expertise in
each of these fields which would be extremely valuable to the
Interagency Task Force on Antimicrobial Resistance in setting and
maintaining priorities and in carryout out its responsibilities. For
this reason, IDSA strongly recommends that FDA, NIH and CDC create an
advisory board to advise the existing Interagency Task Force on
Antimicrobial Resistance. Such an advisory board should meeting with
Task Force members on a regular (biannual) basis. For a list of the
advisory board's potential duties and responsibilities see H.R. 3697/S.
2313, the "Strategies to Address Antimicrobial Resistance Act".

[**Recommendation \#** **5**]{.underline} **  *FDA Should Reevaluate And
Strengthen Regulatory Requirements On Data Collection Of Antibacterial
Use In Humans.*  **

FDA should reevaluate (including by holding a public workshop) the
manner by which it collects antibacterial drug human use data from
pharmaceutical companies to determine if it may be collected in a manner
and format that is reliable and comparable and which best ensures it is
of maximum value to the study of antibacterial resistance development
(e.g., using defined daily doses, collected by calendar year). In
addition, the agency should seek an agreement with IMS Health or another
private vendor to obtain antibacterial drug human use data in a manner
whereby such data may be shared with the Interagency Task Force on
Antimicrobial Resistance as well as with members of the advisory board
proposed in Recommendation #4.  Of course, members of the Task Force and
advisory board will need to sign confidentiality agreements.

[**Recommendation \#** **6**]{.underline} **  *FDA's Center For
Veterinary Medicine Should Move Quickly To Issue Its Long-Delayed Draft
Regulation And Guidance #146 On Collection Of Data On Antibacterial Use
In Animals.***

 

FDA's Center for Veterinary Medicine (CVM) should move forward
immediately to issue for public comment its draft Guidance #146 and
draft regulation developed in 2001 and 2002, which were intended to
redefine the type of antibacterial distribution data that animal drug
manufacturers must provide to the agency on antibacterial drug use in
animals.  The draft regulation and guidance have been held up within the
agency since 2002 for unknown reasons.  It is extremely important that
animal antibacterial drug use data be collected in a manner and format
that is reliable and comparable and which best ensures it is of maximum
value to the study of antibacterial resistance development (e.g.,
collection using \"defined daily doses,\" by species and indication, and
based on a calendar year model as opposed to the anniversary date of the
product's approval).  The collection of such use data will make
information currently collected under the National Antimicrobial
Resistance Monitoring System of greater relevance as it can be used to
show where there may be correlations between antibacterial use and the
development of resistance. This likely will be one of those instances
where the Administration will need to muster substantial political will
to overcome special interests in favor of public health and patient
safety.

 

**[Recommendation \# 7]{.underline}**   ***FDA/CVM Should Update
Guidance #152 To Include Missing Criteria Concerning The Relative
Importance Of Antibacterials In Human Medicine.*** 

 

FDA's CVM should hold a public workshop to bring together experts in
infectious diseases human and veterinary medicine as well as other key
stakeholders to reassess the criteria currently contained in CVM's
Guidance #152 with regard to their potential impact on resistance
patterns in human drugs. Guidance #152 is the framework document used
for the approval of antibacterial drugs for use in animals. In
particular, the agency should reconsider the criteria used to categorize
antibacterial drugs as "critically important" and "highly important" to
human health and whether the scope of such criteria should be broadened
beyond enteric pathogens. Additionally, the agency immediately
should change the classification of cefepime to "critically important\"
to be consistent with the World Health Organization's classification of
this drug. Cefepime is the only 4^th^ generation cephalosporin in use in
the United States in humans, and IDSA and other expert organizations
have emphasized the threat posed both to cefepime and to 3^rd^
generation cephalosporins by the prospect of 4^th^ generation
cephalosporin use in livestock.

 

[**Recommendation \#** **8**]{.underline}  ***FDA Should Move Forward
Immediately To Implement Its Own Recommendations On Antimicrobial
Resistance.***

 

In December 2000, FDA's Task Force on Antimicrobial Resistance issued a
report
(<http://www.fda.gov/oc/antimicrobial/taskforce2000.html>) containing
priority recommendations the agency was to implement to address the
antimicrobial resistance and pipeline problems. Few of these
recommendations have been implemented to date. Such inaction can only be
interpreted as demonstrating the Agency's past lack of commitment to a
brewing crisis that Infectious Diseases physicians believe should be a
significant priority of the U.S. Government. IDSA hopes that along with
the Agency's desire to hold today's Part 15 hearing, we are witnessing a
turning point in the Agency's thinking and a demonstration of it's
desire to tackle these critical patient safety and public health
problems. To confirm this, the Agency should act immediately to dedicate
the necessary resources necessary to implement its own Task Force's
recommendations as well as the additional recommendations that IDSA is
proposing today.

**[Recommendation # 9]{.underline}** **  *FDA Should Require That
Antibacterial Impact Statements And Management Plans Intended To Predict
And Limit Resistance Development Be Included In Human Drug
Applications.***

FDA should require antibacterial drug sponsors (both pioneer and
generic) to submit as part of their drug applications a resistance
impact statement that attempts to predict how approval and use of such
antibacterial drug may impact upon the development of resistance. 
Pioneer and generic sponsors of human drugs also should be required to
submit antibacterial use management plans intended to be used to limit
the development of resistance associated with the drug's use. Such
impact statements and management plans should be made public so that
researchers may use each to study and strengthen our understanding of
the science of predicting resistance development as well as how to
prevent and control its development.  Neither the impact statement nor
management plan should be used for enforcement purposes.  

[**Recommendation** **#10**]{.underline}   ***FDA Should Commission A
Study Through The Tufts Center On The Study Of Drug Development (Or
Another Appropriate Entity) To Obtain Expert Recommendations As To Which
Incentives Are Necessary To Strengthen The Antibacterial Drug, And
Relevant Diagnostics And Vaccine Pipelines.*  ** 

 

New products (antibacterial drugs, vaccines, diagnostic tests) are
critically needed to treat and prevent serious and life-threatening
antibacterial resistant infections as well as to rapidly detect the
organism causing that infection. New rapid diagnostic tests will be
particularly useful in helping to reduce the numbers of
patients needed to demonstrate the safety and effectiveness of
antibacterial drugs in clinical trials. 

Tax credits for R&D, extensions on periods of market exclusivity,
strengthening of intellectual property rights, priority FDA review
vouchers, grants, prizes and other incentives have all been offered as
potential incentives. IDSA does not have all of the answers as to which
combination of incentives will ultimately be successful.

Within the federal Interagency Task Force's Action Plan to Combat
Antimicrobial Resistance issued to 2001, FDA was designated to take the
lead on implementing two of the thirteen "Top Priority Action Items."
These include:

 

***"Top Priority Action Item** --- Create an Interagency AR Product
Development Working Group to identify and publicize priority public
health needs in human and animal medicine for new AR products (e.g.,
innovative drugs, targeted spectrum antibiotics, point-of-care
diagnostics, vaccines and other biologics, anti-infective medical
devices, and disinfectants)."*

 

***"Top Priority Action Item** --- Identify ways (e.g., financial and/or
other incentives or investments) to promote the development and/or
appropriate use of priority AR products, such as novel compounds and
approaches, for human and veterinary medicine for which market
incentives are inadequate."*

 

To date, FDA has done nothing to address either Top Priority Action
Item.

 

Arguably, neither FDA nor any federal agency is well-placed to examine
and make recommendations about the type of incentives that will promote
antibacterial drug development. However, the Tufts Center for the Study
of Drug Development commonly studies pharmaceutical pipelines and the
pharmacoeconomic and non-economic factors that spur drug development.
For this reason, IDSA strongly urges FDA to commission a study through
the Tufts Center (or some other similar entity, if one exists) seeking a
report on strengths and weaknesses in the antibacterial and related
diagnostics and vaccine R&D pipelines with a particular emphasis on
products needed to treat, detect, and prevent serious and
life-threatening infections.  The study also should provide
recommendations as to what combination of incentives, considering each
phase of product development, will work to spur greater R&D of such
products among the biotechnology, pharmaceutical, vaccine, and
diagnostics industries as well as within academic settings.   

 **[Recommendation #11]{.underline}  *FDA Should Immediately Clarify Its
Policies Under The Orphan Drug Act Relating To Serious and
Life-Threatening Infectious Diseases Associated With Antibacterial
Resistant Organism.*** 

FDA should immediately clarify how it calculates prevalence of cases
under the Orphan Drug Act related to serious and life-threatening
infectious diseases associated with antibacterial resistant organisms. 
Agency officials have provided contradictory messages on this point,
which has had a negative impact on IDSA\'s ability to advocate for the
adoption of new statutory incentives to spur R&D on products that will
protect patient safety and public health.  

**[Recommendation #12]{.underline}  *FDA Should Effectively Communicate
Its Professional Judgment As To The Funding It Needs To Sufficiently
Address The Antimicrobial Resistance Problem.***

The Department of Health and Human Services (HHS), including FDA, NIH,
and CDC need to effectively communicate the resources the department and
agencies need to address antimicrobial resistance. Last year, two
members of Congress \[Reps. Jim Matheson (D-UT) and James McGovern
(D-MA)\] asked Secretary Leavitt during an HHS' budget hearing for
FDA's, NIH's, and CDC's professional judgments concerning the amount of
funding each agency needs to implement their respective responsibilities
under the federal Action Plan to Combat Antimicrobial Resistance.  It is
unclear whether FDA ever submitted its professional judgment request to
HHS. However, it is clear that HHS did not submit any professional
judgments to the Congressmen.