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Strategies to Address AntiMicrobial Resistance (STAAR) ACT

Floor Speech

Location: Washington, DC

STRATEGIES TO ADDRESS ANTIMICROBIAL RESISTANCE (STAAR) ACT -- (Extensions of Remarks - September 27, 2007)

* Mr. MATHESON. Madam Speaker, I rise to introduce the ``Strategies to Address Antimicrobial Resistance (STAAR) Act,'' which I believe has the potential to save many thousands of lives by strengthening the United States' response to infectious pathogens that are becoming increasingly resistant to existing antibiotics. I am proud to introduce this legislation with my colleague, Rep. Mike Ferguson, as a concrete step towards addressing antibiotic resistance.

* Media reports about the threat of resistant infections now occur on almost a daily basis. Earlier this year, media attention regarding extensively-drug resistant tuberculosis (XDR-TB) made this topic common conversation in our homes and offices. Suddenly we were forced to think about how quickly an infection can spread, especially in the age of international air travel, and the disastrous result if the cause was a strain of bacteria that failed to respond to our current antibiotics.

* Another resistant infection drastically on the rise is community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). Historically, this infection was acquired during a hospital stay, but now is affecting young, healthy people and spreading in our communities. We've heard stories of high school, college and professional athletes losing their lives or careers as a result of these infections. Sadly, this infection has become far too common, difficult to treat and has few options to fight it. It can leave individuals disfigured, if they survive. In my own state of Utah, the number of children with MRSA infections at the Primary Children's Medical Center in Salt Lake City has increased by almost 20 fold since 1989.

* There are still more infections to worry about. We have numerous reports of our soldiers coming home from Iraq with Acinetobactor--a resistant infection that is especially difficult to treat and the only option is a very toxic antibiotic.

* Other examples of concern include vancomycin-resistant Staphylococcus aureus (VRSA), an alarming development because vancomycin is the drug of last resort for treating several serious infections, and Escherichia coli (E. coli), which has caused outbreaks due to contamination of spinach, peanut butter, and other foods we regularly consume.

* We have taken antibiotic development for granted. Few of us remember medicine before the discovery of antibiotics. Antibiotics have allowed many medical advances, including routine invasive surgeries, organ transplants, and other procedures that otherwise would be impossible due to resulting infections. But we are falling behind in our ability to protect ourselves against infections, and we have a lot of catching up to do.

* In addition, there are problems of significant and inappropriate use of antibiotics; a lack of adequate research to address the many facets of resistance, including basic, clinical, interventional, and epidemiologic research as well as research to support the development of new diagnostics, biologics, devices and, of course, antibiotics; a fractured and underfunded resistance surveillance system; and insufficient coordination of the federal response, which is critically needed as the solutions to addressing antibiotic resistance involve multiple agencies and departments.

* I am not the first person in the United States Congress to take on this issue. I feel certain, however, that the STAAR Act is the most comprehensive legislation introduced to date to address this serious and life-threatening patient safety and public health problem. There is no doubt that we must act now to begin to reverse the alarming trend, and infectious disease experts tell me that the multi-pronged approach contained in the STAAR Act provides our best chance to address the multiple problems that face us.

* I commend my many colleagues who have demonstrated leadership on this issue over the years, especially Chairman Dingell. He recognized this issue nearly 15 years ago and asked the Congressional Office of Technology Assessment (OTA) to examine the problem of antimicrobial resistance. In 1995, OTA reported to Congress that ``The impacts of antibiotic-resistant bacteria can be reduced by preserving the effectiveness of current antibiotics through infection control, vaccination and prudent use of antibiotics, and by developing new antibiotics specifically to treat infections caused by antibiotic resistant bacteria.''

* Also, I would like to recognize the leadership of my colleague from Michigan, Mr. Stupak. In the 106th Congress, he and our former colleague, Mr. Burr, introduced the ``Public Health Threats and Emergencies Act.'' Parts of this bill became law and provide the basis of the legislation I introduce today. Specifically, that bill, which is expressed in Section 319E, ``Combating Antimicrobial Resistance'' of the Public Health Service Act, directed the Secretary to establish an Antimicrobial Resistance Task Force to coordinate Federal programs relating to antimicrobial resistance. Also, the bill required research and development of new antimicrobial drugs and diagnostics; educational programs for medical and health personnel in the use of antibiotics; and grants to establish demonstration programs promoting the judicious use of antimicrobial drugs and the detection and control of the spread of antimicrobial-resistant pathogens. Authorization for these programs expired September 30, 2006. The STAAR Act reauthorizes these programs and builds on the Federal efforts that have been highlighted in the Public Health Service Action Plan to Combat Antimicrobial Resistance, published in 2001 by the Task Force.

* The Action Plan identified thirteen key elements (out of 84 elements) as top priority action items that are critically necessary to address the growing resistance crisis. Only months after the release of the Action Plan, our former colleague Mr. Brown and many of my colleagues on the Energy and Commerce Committee, including Chairmen Dingell and Pallone, and Mr. Waxman, Mr. Towns, Mr. Green, and Ms. DeGette, introduced the``Antibiotic Resistance Prevention Act of 2001.''

This legislation sought to provide additional funding specifically for the top priority action items in the Action Plan. My colleagues recognized the urgency of this situation and explained that ``The Institute of Medicine, the American Society for Microbiology, the World Health Organization, the Congressional Office of Technology Assessment, and the General Accounting Office each have found that the Nation should improve surveillance for mounting antimicrobial resistance problems; prolong the useful life of antimicrobial drugs; develop new drugs; and utilize other measures, such as improved vaccines, diagnostics, and infection control measures to prevent and control antimicrobial resistance.''

* Although Congress has taken steps in the past to address the problem, antimicrobial resistance continues to grow. In 2004, the Infectious Diseases Society of America (IDSA) published, ``Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates a Public Health Crisis Brews'' to highlight the lack of research and development for new antibiotics. Antibiotics are not profitable compared to those that treat chronic (long-term) conditions and lifestyle issues. In addition, when a new antibiotic comes on the market, it is discouraged from use to avoid the development of resistance. Also, antibiotics are taken for short periods of time--unlike those for chronic disease which may be taken daily.

* Earlier this year, Mr. Baird, Ms. Cubin and I introduced legislation to provide tax credits and other incentives for antibiotic research and development, as well as to encourage that antibiotics, vaccines, and diagnostics become more commonly manufactured in the United States.

* Last week, Congress sent the FDA Amendments Act to the President for signature. This legislation included antibiotic provisions I supported and offered as an amendment during committee consideration. Specifically, the FDA Amendments Act promotes education regarding what incentives may be available through the Orphan Drug program for antibiotics and improves information laboratories and clinicians have about antibiotic resistance.

* The ``Strategies to Address Antimicrobial Resistance (STAAR) Act'' compliments these past legislative efforts. The STAAR Act is comprehensive legislation that advances the thirteen key elements identified in the Action Plan and authorizes adequate funding for these strategies.

* My bill strengthens existing efforts by establishing an Office of Antimicrobial Resistance (OAR) within the HHS Office of the Assistant Secretary of Health. The Director of OAR would serve as the director of the existing interagency task force. Also, to encourage input from experts outside the federal government, my bill would establish a Public Health Antimicrobial Advisory Board (PHAAB) to provide much needed advice about antimicrobial resistance and strategies to address it. The STAAR Act will strengthen existing surveillance, data collection, and research activities as a means to reduce the inappropriate use of antimicrobials, develop and test new interventions to limit the spread of resistant organisms, and create new tools to detect, prevent and treat these ``bad bugs'' for which there are no drugs. Infectious diseases experts, including the IDSA, have said it strongly supports this multi-faceted, strategic approach.

* I appreciate the interest and leadership many of my colleagues have demonstrated on this issue in the past. This legislation has been a long time coming. I appreciate the effort of my colleague, Mr. FERGUSON, who joins me to introduce this bipartisan legislation. Finally, I urge my colleagues to work with me to give our federal agencies the tools they need to ensure that combating antimicrobial resistance becomes a priority.


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