[Congressional Record Volume 153, Number 171 (Tuesday, November 6, 2007)]
[Senate]
[Pages S13996-S13998]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BROWN (for himself and Mr. Hatch):
  S. 2313. A bill to amend the Public Health Service Act to enhance 
efforts to address antimicrobial resistance; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. BROWN. Mr. President, today, I am introducing the Strategies to 
Address Antimicrobial Resistance Act. This bill, also known as the 
STAAR Act, is meant to reinvigorate efforts to combat antimicrobial 
resistance--efforts that accelerated in the late 90s but then stalled.
  I want to thank Senator Hatch for his leadership on this issue and 
for introducing this bill with me. I look forward to working with him 
to ensure it passage.
  Antibiotics are the cornerstone of modern medicine, relied on to 
treat countless diseases and responsible for some of the great advances 
in public health in the 20th century. But over time, bacteria, viruses, 
and other pathogens have mutated to develop resistance to antibiotic 
drugs. This is a dangerous setback for modern medicine. Infections 
caused by drug-resistant bacteria can cause serious, prolonged, and 
debilitating illnesses, and even death.
  Methicillin-resistant Staphylococcus aureus, MRSA, is a drug 
resistant infection that can be contracted not only in hospitals but in 
community settings such as gyms and playgrounds. A study that was 
published in the Journal of the American Medical Association last month 
projected that the number of deaths from MRSA exceeded the number from 
AIDS in 2005. That statistic alone should be a wake-up call for 
America. We need to respond quickly to this problem, because it will 
only grow worse with time.
  We are creating these deadly infections. We create them by using 
antibiotics when we do not need to and by not following through on the 
full regimen of antibiotic therapies as prescribed. More consistent and 
thorough hand washing in health care settings can also make a huge 
difference.
  Several of our Government agencies are involved in efforts to address 
antimicrobial resistance. However, we need more coordination among all 
the federal agencies involved. This bill seeks to facilitate that 
coordination by establishing an Office of Antimicrobial Resistance at 
the Department of Health and Human Services. The bill also reauthorizes 
an interagency task force that has already done significant legwork on 
this issue so that, spearheaded by the coordinating office, Federal 
agencies can turn that legwork into action. The STAAR Act calls for a 
comprehensive research plan that would identify knowledge gaps and 
recommend strategies for filling those gaps. It would significantly 
improve surveillance by establishing a multi-site surveillance network 
and working to ensure uniformity in State collection of antimicrobial 
resistance data.
  Drug-resistant infections set back the clock on medical progress. 
They cost money and more importantly, they take lives. We need to take 
antimicrobial resistance seriously and fight it with as much passion as 
we fight any potential killer.
  Mr. HATCH. Mr. President, as recent events in neighboring Virginia 
have made all too clear, this country faces a number of troubling 
questions about whether we are prepared to address the growing problem 
of drug-resistant, bacterial infections. Indeed, while recent media 
reports have raised the visibility of this issue, infectious disease 
doctors have been sounding the alarm for years.
  Now, Senator Brown and I are sounding the alarm as well.
  Data from the Centers for Disease Control and Prevention show that 
resistant strains of infections have spread rapidly. This alarming 
trend continues to grow and treatment options are sorely lacking.
  Senator Brown and I have collaborated to develop legislation that 
takes a science-based approach to this problem. This legislation, the 
Strategies to Address Antimicrobial Resistance Act or STAAR Act S. 
2313, should be seen as a measure to catalyze a greater Government 
focus on a frightening, growing, public health problem which should be 
of concern to each and every one of us in this Nation.

[[Page S13997]]

  One of the things that Senator Brown and I have found in our 
considerable study of this issue is that there is not adequate 
infrastructure developed within the Government to collect the data, to 
coordinate the research, and to conduct the surveillance necessary to 
stop drug-resistant infections in their tracks.
  We believe that jump-starting a greater, stronger, organizational 
focus at the Department of Health and Human Services will help our 
Government and our scientists develop an infrastructure that can grow 
as science develops.
  At the same time, we make perfectly clear that our bill is not the 
sole answer to the complex, vexing problem of antibiotic resistance. At 
a minimum we need better testing, better hospital controls, better 
medications, and better funding to support these efforts, particularly 
the work of the Centers for Disease Control and Prevention.
  The Infectious Diseases Society of America, the Institute of 
Medicine, the Resources for the Future, the Centers for Disease 
Control, and many others have been sounding the alarm about the growing 
threat from resistant microorganisms.
  Congress must listen.
  In fact, it its seminal report, ``Bad Bugs, No Drugs'', the 
Infectious Diseases Society, IDSA, said:

       Drug-resistant bacterial infections kill tens of thousands 
     of Americans every year and a growing number of individuals 
     are succumbing to community-acquired infections. An epidemic 
     may harm millions. Unless Congress and the Administration 
     move with urgency to address these infections now, there is a 
     very good chance that U.S. patients will suffer greatly in 
     the future.

  Indeed, the seminal IDSA report points out a number of compelling 
facts.
  As the report notes, infections caused by resistant bacteria can 
strike anyone, young and old, rich or poor, healthy or ill. However, 
the problem of antibiotic resistance is especially acute for patients 
with compromised immune systems, such as persons living with HIV/AIDS.
  The scope of the problem is equally of note. As IDSA has calculated, 
about 2 million people acquire bacterial infections in U.S. hospitals 
each year and as many as 90,000 die as a result. More and more, public 
health experts are finding infections developed in the home or 
community as well. Infections in both settings are increasing, and the 
resultant drug resistance shows no sign of lessening.
  This is a costly problem, costly for patients, for society, and 
potentially threatening to our global security.
  And, in fact, health care providers are running out of treatments as 
the resistance problem grows.
  Nobel Laureate Joshua Lederberg said it well: ``We are running out of 
bullets for dealing with a number of bacterial, infections. Patients 
are dying because we no longer in many cases have antibiotics that 
work.''
  Indeed, last week, noted Utah infectious disease expert Dr. Andy 
Pavia told me about a 14-year-old boy he had treated who had bone, 
muscle and lung infections from MRSA, an aggressive, difficult to 
treat, form of staph that has spread rapidly within communities. Half 
of the children he sees with severe MRSA infections acquired their 
infection at home.

  This young man, Dr. Pavia relates, was forced to undergo multiple 
surgeries and 6 weeks of intravenous antibiotics. MRSA infections are 
steadily increasing in Utah, as well as across all other States.
  Fortunately, that young man is on the road to recovery. But the 
statistics indicate it is just as likely that he would not be.
  We are not only talking about MRSA. Dr. Pavia also cites the real 
crisis growing with resistant gram-negative bacteria, which he calls 
the ``Rodney Dangerfield of the infectious disease world''--in other 
words, ``it don't get no respect.''
  We are also seeing increases in extensively drug-resistant, XDR, 
tuberculosis. There are numerous reports of soldiers returning home 
from Iraq with Acinetobactor--a resistant infection that is especially 
difficult to treat, and the only option is a very toxic antibiotic.
  Senator Brown and I have worked on this issue for many months, 
starting with our collaboration on provisions in the Food and Drug Act 
Amendments recently signed into law by the President. We are also 
working with our colleagues in the House, foremost among them Utah 
Congressman Jim Matheson, author of the House STAAR Act.
  Our conclusion is that the solutions to this problem are manifold, 
but they must start with a stronger Government effort. That is the 
genesis of the STAAR Act.
  Let me review briefly what our legislation does.
  The bill makes a series of congressional findings which layout the 
problem and the need to address it.
  In particular, we note that while the advent of the antibiotic era 
has saved millions of lives and allowed for incredible medical 
progress, the increased use and overuse of antimicrobial drugs have 
correlated with an increase in the rates of antimicrobial resistance.
  An important component to this problem is the fact that scientific 
evidence suggests the source of antimicrobial resistance in people is 
not only the overuse of human drugs, but also it may be from food-
producing animals, which are exposed to antimicrobial drugs.
  As scientists have found, nearly 70 percent of hospital-acquired 
bacterial infections in the U.S. are resistant to at least one drug; in 
some cases, the rate is much higher. In fact, each year nearly 2 
million people contract bacterial infections in the hospital, and it is 
estimated that 90,000 of them die from the infections.
  There seem to be no recent data on the costs associated with this 
problem, but a 1995 report by the Office of Technology Assessment found 
that six different antimicrobial-resistant strains of bacteria 
accounted for $1.3 billion in nationwide hospital costs--almost $1.9 
billion in 2006 dollars!
  Here is how our bill attempts to address the problems I have just 
laid out.
  First, the bill establishes a new Office of Antimicrobial Resistance 
in the Department of Health and Human Services. That Office will work 
with the Task Force to issue biennial updates to the Public Health 
Action Plan to Combat Antimicrobial Resistance, including enhanced 
plans for addressing the problem here and abroad. As appropriate, the 
Office's Director will establish benchmarks for achieving the plan's 
goals, assess patterns of antimicrobial resistance emergence and their 
impact on clinical outcomes, determine how antimicrobial products are 
being used in humans, animals and plants, and recommend where 
additional federally-supported studies may be beneficial.
  Second, we renew the Antimicrobial Resistance Task Force authorized 
in section 319E of the Public Health Service Act. The Task Force, whose 
authorization lapsed last year, is comprised of representatives from 
the following Federal agencies and offices, plus any others the 
Secretary deems necessary: the new Office of Antimicrobial Resistance 
established in the bill; the Assistant Secretary of Preparedness and 
Response; the Centers for Disease Control; the Food and Drug 
Administration; the National Institutes of Health; the Agency for 
Healthcare Research and Quality; the Centers for Medicare & Medicaid 
Services; the Health Resources and Services Administration; the 
Environmental Protection Agency; and the Departments of Agriculture, 
Education, Defense, Veterans Affairs, Homeland Security, and State.
  It is important to note that Senator Brown and I gave careful 
consideration to the location of this new Office.
  We considered locating it at the CDC, the Office of the Assistant 
Secretary for Health (OASH), and in the Office of the Secretary, OS. 
There are benefits and drawbacks to each. Indeed, had OASH its previous 
organizational structure, that is, line authority over the Public 
Health Service agencies, that decision would have been easy. But since 
a change was made many years ago to devolve most of the OASH functions 
to the separate PHS agencies, OASH was not the natural locus for the 
new Office, we decided. Our final conclusion was that it was most 
appropriate to locate the new office in OS, both for reasons of 
prominence and flexibility.
  Third, S. 2313 establishes a Public Health Antimicrobial Advisory 
Board, a panel of outside experts who will advise the Secretary on ways 
to encourage an adequate supply of antimicrobial products that are both 
safe

[[Page S13998]]

and effective; help determine what research priorities should be, what 
data and surveillance are necessary to be collected, and assess how the 
action plan can be updated and strengthened.
  It is very important to Senator Brown, if I may speak for him, and to 
me that our measure be seen as a collaborative effort that draws on the 
strengths of existing organizations and catalyzes their efforts for 
greater good.
  So, fourth, our bill requires the Secretary--working through the new 
Office, the CDC and the NIH, in consultation with other appropriate 
agencies--to develop a antimicrobial resistance strategic research plan 
that strengthens existing epidemiological, interventional, clinical, 
behavioral, translational and basic research efforts to advance our 
understanding of the emergence of resistance and how best to address 
it.
  Fifth, the bill authorizes establishment of at least 10 Antimicrobial 
Resistance Clinical Research and Public Health Network sites, 
geographically dispersed across the U.S. The sites will monitor the 
emergence of resistant pathogens in individuals, study the epidemiology 
of such pathogens and evaluate the efficacy of interventions, and study 
problems associated with antimicrobial use. In addition, we are asking 
the network to assess the feasibility, cost-effectiveness, and 
appropriateness of surveillance and screening programs in differing 
health care and institutional settings, such as schools, and evaluate 
current treatment protocols and make appropriate recommendations on 
best practices for treating drug resistant infections. It is my hope 
the network will be able to take into account successful models for 
surveillance and screening such as inpatient programs of the Veterans 
Health Administration, work done in States such as Illinois, New York 
and the Utah Aware program, and experience overseas in countries such 
as the Netherlands, Denmark and Finland. Our bill authorizes $45 
million for these networks in fiscal year 2008, $65 million next year, 
and $120 million in fiscal year 2010.
  Finally, I would like to speak about data collection activities in S. 
2313.
  It has become obvious to me that there is a pressing need for better 
surveillance of antibiotic resistance and better data collection that 
is shared both within States and across States. From my long work on 
public health issues, it is equally clear to me that there is a need 
for the government to give guidance--guidance, not a mandate--on 
uniform ways in which those data should be collected so that all of the 
agencies are talking the same talk, so speak.
  Our bill asks the Office of Antimicrobial Research to work with the 
Task Force and member agencies to develop those uniform standards for 
data collection. In drafting S. 2313, Senator Brown and I were very 
sensitive to the jurisdictional needs of other Committees. At the same 
time, it is clear that any serious effort to address antimicrobial 
resistance must be spread across the many agencies of Government, each 
of which has a role to play in our collaborative effort. It is for that 
reason that our bill asks the Office and Task Force to work with the 
other agencies, some of which do not fall within the jurisdiction of 
the HELP Committee. If this language needs to be strengthened as 
consideration of S. 2313 progresses, it is our hope to work with the 
other committees which have an interest in the bill.
  A second issue related to data collection is the fact that there is a 
pressing need for epidemiologists and other public health experts to 
begin to see data showing how many antibiotics are being distributed 
and used by patients so that they can evaluate the amount of resistance 
that is emerging. In writing our bill, we were sensitive to the need to 
provide scientists with these data, while at the same time working to 
make any new reporting provisions the least burdensome possible, while 
protecting both the national security and propriety aspects of those 
data. For that reason, our bill builds on current reporting to the FDA 
of pharmaceutical distribution data. Those data are currently submitted 
by manufacturers on the anniversary date of the product's approval. Our 
bill would move that reporting date to 60 days after the beginning of 
each calendar year, thus allowing epidemiologists to compare data from 
year to year. Our second concern, that of potentially harmful release 
of data, was addressed in the following way. Our bill precludes the 
release of data which are proprietary in nature and whose release could 
have the perverse result of providing a disincentive to antibiotic 
development. This strong section, section 7 of the bill, also precludes 
release of data which could be harmful to our national defense.
  In closing, I wish to commend S. 2313 to my colleagues and ask for 
their serious consideration of this measure. For those who doubt the 
need for this legislation, if there are any doubters among us, I ask 
the following questions:
  Where do we begin to get serious to address this concern?
  Where do we begin to recognize that it will take literally years to 
develop an effective response?
  What are we doing to develop the collaboration across agencies to 
assure the American public we are developing an action plan to combat 
the problem?
  It is our hope that STAAR Act will begin to catalyze that response.
  That is the motive behind our introduction of this legislation.
  We look forward to working with our colleagues on the Health, 
Education, Labor and Pensions Committee as consideration of this 
legislation begins and we remain available to our colleagues to answer 
any questions or concerns they may have about this legislation.
                                 ______