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Antibiotic Development: The 10 x '20 Initiative

Background

Pharmaceutical companies are withdrawing from antibiotic development due to antibiotic resistance and antibiotics’ low return on investment. IDSA is working on multiple fronts to counter the decline of antibiotic research and development (R&D). We provide input to the Food and Drug Administration (FDA) to bring regulatory clarity to the antibiotic approval pathway and advocate to Congress to advance the adoption of statutorily-defined incentives with sufficient power to encourage manufacturers to (re)engage in antibiotic and related diagnostic R&D.

In 2010, IDSA launched "the 10 x ’20 Initiative" to bring together the diverse stakeholders needed to create a sustainable antibiotic R&D infrastructure—and 10 new, safe and effective, systemic antibiotics—by 2020. Without immediate action by FDA and Congress, our children and grandchildren will be less likely to have access to life-saving antibiotics.
Watch Theresa Drew speak on World Health Day, 2011 about her son, Ricky Lannetti's death from MRSA.

Antibiotic-resistant bacterial infections kill tens of thousands of Americans each year. If you or a loved one has been harmed and you would like to support IDSA’s advocacy efforts by sharing your story, please contact John Heys.

See elsewhere:

	Additional Patient Stories Learn about other patients and families who have been harmed by antibiotic-resistant bacterial infections.
	10 x '20 Endorsing Organizations 33 medical societies and 14 other organizations have endorsed the 10 x '20 Initiative to date.
	IDSA’s Other Antimicrobial Resistance Policy Efforts View other IDSA policy work specific to antimicrobial resistance public health and research as well as the judicious use of antimicrobials in human medicine and in agriculture.

Additional background documents

12/21/2011
Bad Bugs no Drugs: Why Antibiotics Deserve Congress' Attention and Immediate Action (PDF)
IDSA presentation to the U.S. Senate antibiotic legislation working group by Robert Guidos, JD, IDSA VP, Public Policy & Government Relations.
12/19/2011
CDC Fact Sheet on Drug-Resistant Gonorrhea (PDF)
CDC highlights increasing cases of drug-resistant gonorrhea, which pose serious health and economic consequences.
08/05/2011
IDSA One-Pager Proposing the Establishment of an Infectious Disease (ID) Clinical Specimen Repository (PDF)
IDSA has proposed the establishment of an ID clinical specimen repository, which would strengthen ID research and critically needed diagnostics development by reducing redundancies, assuring quality specimens are collected, and saving valuable time and resources.
05/22/2011
Stoking the Antibiotic Pipeline (PDF)
Morel and Mossialos, British Medical Journal vol. 340 no. 1186 May 22, 2010 1115-1118.
04/15/2011
New Drugs to Tackle Antimicrobial Resistance: An Analysis of EU Policy Options
Sharma and Towse, Office of Health Economics April 2011.
Outlines a model that assess the push, pull and hybrid approaches that could be applied to encourage innovation of antimicrobials and suggests the size of various incentives needed to make antibiotic R&D as attractive to developers as are other therapeutic drug classes.
04/07/2011
Download a fact sheet about antibiotic resistance (PDF)
04/07/2011
IDSA's World Health Day 2011 Background Materials
10/19/2009
Antibiotic-Resistant Infections Cost the U.S. Healthcare System in Excess of $20 billion Annually
PR Newswire October 19, 2009.
Extrapolating the 2009 Roberts study [CID vol. 49 no. 8 October 15, 2009 1175-1184.) see below] nation-wide, the authors concluded antibiotic-resistant infections cost the U.S. health care system in excess of $20 billion annually as well as more than $35 billion in societal costs and more than 8 million additional days spent in the hospital.
10/15/2009
Antibiotic Resistance: Who Will Pay the Bills? (PDF)
Zaoutis, Clinical Infectioius Diseases vol. 49 no. 8 October 15, 2009 1185-1186.
10/15/2009
Hospital and Societal Costs of Antimicrobial-Resistant Infections in a Chicago Teaching Hospital: Implications for Antibiotic Stewardship (PDF)
Roberts et al., Clinical Infectious Diseases vol. 49 no. 8 October 15, 2009 1175-1184.
A recent analysis of antibiotic-resistant infection data from Chicago Cook County Hospital showed that the direct and indirect economic costs of antibiotic resistance are enormously high in terms of dollars and length of hospital stays.
09/17/2009
Policies and Incentives for Promoting Innovation in Antibiotic Research
Mossialos et al., London School of Economics & Political Science September 17, 2009.
Professor Elias Mossialos, with LSE Health, presented a report commissioned by the Swedish government on the challenges concerning antibiotic resistance.
09/17/2009
The Bacterial Challenge--Time to React (PDF)
ECDC/EMEA Joint Technical Report, September 17, 2009.
The technical report on the lack of new antibacterials from the European Medicines Agency (EM)-European Centre for Disease Prevention and Control (ECDC) in collaboration with ReAct.
02/01/2006
Changes in the Epidemiologoy of Methicillin-Resistant Staphylococcus aureus in Intensive Care Units in U.S. Hospitals, 1992-2003 (PDF)
Klevens et al., Clinical Infectious Diseases vol. 42 no. 3 February 1, 2006 389-391.

01/15/2006
Prevalence of Staphylococcus aureus Nasal Colonization in the United States, 2001-2002 (PDF)
Kuehnert et al., Journal of Infectious Diseases vol. 193 no. 2 January 15, 2006 172-179.
05/01/2004
Trends in Antimicrobial Drug Development: Implications for the Future
Spellberg et al., Clinical Infectious Diseases vol. 38 no. 9 May 1, 2004 1279-1286.
Bad Bugs Need Drugs: Image Gallery (PDF)
Electron micrograph images of the six antibiotic-resistant bacteria.
Organizations Endorsing IDSA's 10 x '20 Initiative

TAKE ACTION!

What can you do to help? Urge Congress to pass legislation to spur research and development of new antibiotics, as part of the Prescription Drug User Fee Act (PDUFA) reauthorization bill. Send an email to your congressional representatives today.

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Antibiotic Development: The 10 x '20 Initiative

Background

TAKE ACTION!

Infectious Diseases Society of America