Bad Bugs, No Drugs
As Antibiotic Discovery Stagnates  . . . A Public Health Crisis Brews

Download white paper (PDF, 37 pgs) 7/2004
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Read the Executive Summary
Learn about IDSA's concerns about the lack of new antibiotics to fight drug-resistant infections and proposed novel measures to avert this looming crisis.

Bad Bugs, No Drugs Patient Stories
Stories of patients and families who have been affected by infections such as MRSA.

State-Specific Information on Antibiotic Resistance
Working with State Epidemiologists, IDSA has summarized information of the antibacterial drug resistance problem in all 50 U.S. states.

IDSA Staff Contacts

Media and the Public:
John Heys (703) 299-0412
Diana Olson (703) 299-0201
Federal Policymakers:
Robert J. Guidos, JD (703) 299-0200
Michael Ochs (703) 740-4790

(Download a PDF of these charts)

IDSA Statements

• IDSA’s 10 X ’20 INITIATIVE: ID Experts Call for 10 Novel Antibacterial Drugs by 2020 11/20/2009
  In its letter to President Obama and Swedish Prime Minister Reinfeldt, the Society asks for a Global Commitment to Develop New Antibacterial Drugs. IDSA seeks the creation of an Antibacterial Drug Development Work Group as a component the a new Transatlantic Task Force on antimicrobial resistance established by Obama/Reinfeldt.

• IDSA Outlines Priorities for FDA's Incoming Leaders 06/26/2009 In a letter to Commissioner Peggy Hamburg, IDSA requests a meeting with top agency officials to discuss issues and strategies related to novel H1N1 influenza, impediments to antibacterial drug development, strategies to better address antimicrobial resistance and the use of antimicrobials in animals.  

• Bad Bugs, No Drugs, No ESKAPE: An Update by IDSA (the state of the antibiotic pipeline); Boucher et al 01/01/2009
• IDSA Testimony on Antimicrobial Resistance at FDA Part 15 Hearing 04/28/2008 IDSA testifies at FDA hearing on antimicrobial resistance and makes twelve recommendations on appropriate FDA actions to help lead federal efforts to combat this growing problem.
• IDSA Urges Congressional Action on Antibiotic R&D Incentives Before 2007 Ends 12/17/07 Congress has the opportunity to enact an incentive to encourage new research on "older" antibiotics, and IDSA is urging them to act.
• The Epidemic of Antimicrobial Resistant Infections: A Call to Action for the Medical Community from the Infectious Diseases Society of America January 15, 2008 12/12/07 Published in Clinical Infectious Diseases [CID 2008:46 (15 January)].
• IDSA Endorses 50% Tax Credit for ID Product Research & Development 11/16/2007
  New legislation, S. 2351, introduced by Senator Charles Schumer (D-NY), if enacted, will help to spur the development of new antibiotics, antiviral drugs, vaccines, diagnostics, and biological products to address MRSA, gram-negative bacterial infections, XDR-TB, and other dangerous drug-resistant and other infectious pathogens.
• "Breaking News": Congress Passes Legislation Intended to Strengthen Antibiotic Pipeline, etc.
  New antibiotic provisions, many of which IDSA prompted and promoted, were included in the FDA bill.  President Bush is expected to sign the bill into law.
• IDSA Applauds Inclusion of Antimicrobial Resistance Provisions in New FDA Law
  The Society expressed disappointed, in a letter to congressional leaders, that one important antibiotic development incentive was dropped from the legislation just prior to passage and asked Congress to include it in other pending legislation this year.
• IDSA letter to Drs. Anthony Fauci, NIAID and Julie Gerberding, CDC, Requesting a Strengthened Federal Response to Antimicrobial Resistance. 06/19/07
  IDSA is calling for the creation of an NIH/CDC joint antimicrobial resistance strategic research plan as well as the joint establishment of an Antimicrobial Resistance Clinical Research and Public Health Network as proposed in the Strategies to Address Antimicrobial Resistance Act.
• IDSA Raises Alarm about FDA's Delay in Issuing Anti-Infective Drug Guidelines 09/28/06
  Lack of agency guidelines for industry is having a chilling effect on anti-infective research, development and approvals while patients and physicians are left waiting and wanting.
• IDSA Applauds Senate Leaders for their efforts on S. 3678, the “Pandemic and All Hazards Preparedness Act” (PDF) 08/02/2006
  But endorses independent expert commission and new federal Biomedical Advanced Research and Development Authority to study and stimulate much needed anti-infective drug and vaccine R&D.
• Bad Bugs Need Drugs: An Update on the Development Pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America (PDF, 288.44KB), Talbot et al 03/01/2006
• IDSA/Others Support Resources for FDA Critical Path Plan 01/12/06
  Path's goal is to streamline translation of discoveries into new and better treatments.
• Project Bioshield Reathorization (PDF) 04/06/06
  Statement from Martin J. Blaser, MD, IDSA's President
• IDSA Opposes Stifling Small Business Admin. Action Affecting Biotech and Device R&D 11/08/05
  Building on its "Bad Bugs, No Drugs" effort, IDSA works with coalition to support legislative fix.
• IDSA Supports Provisions to Encourage the Development of New Classes of Antibiotics and Anti-infective Products 10/24/05
  IDSA supports market exclusivity for antibiotics that treat serious and life-threatening infections. Society responds to important legislation moving in Senate.
• IDSA letter to Senator Burr who is finalizing Bioshield II incentives 10/04/05
  As the next version of key legislation is being negotiated, the Society reiterates our belief that novel incentives are the solution to antibiotics future development.
• IDSA endorses the Infectious Disease Research and Development Act of 2005 07/05/2005
  IDSA has endorsed H.R. 3154, The Infectious Diseases Research and Development Act of 2005, a bill sponsored by Congresswoman Barbara Cubin (D-WY). The bill, if enacted, will provide incentives for pharmaceutical and biotechnology companies to invest in research and development with respect to antibiotic drugs, antivirals, diagnostic tests, and vaccines that may be used to identify, treat, or prevent a “qualified infectious disease product.”
• IDSA supports unique patent solution to promote antibiotic R&D 6/24/05
  A letter to Senator Richard Burr, Chair Subcommittee on Bioterrorism and Public Health Preparedness, U.S. Senate Committee on Health, Education, Labor, and Pensions
• IDSA Statement on Senate Bioshield II Bill 4/28/05
• IDSA Statement before HHS Task Force on Stimulating Medical Innovations 11/18/04
  IDSA urges initiative to stimulate innovation in medical technologies, specifically new drugs, vaccines, and diagnostics to treat, prevent, and detect infectious diseases agents, and for antibiotics to treat resistant bacterial infections as well as new rapid diagnostics to detect them.

Press Releases

• 10 X ‘20: ID EXPERTS CALL FOR 10 NEW ANTIBIOTICS BY 2020 11/23/2009
  Infectious Diseases Society of America urges development of new antibiotics to address global drug resistance crisis.
• Infectious Disease Doctors Need New Drugs to Treat Gonorrhea 4/12/2007
• Bad Bugs Need Drugs teleconference 3/1/2006
  Agenda and replay information for the teleconference.

Background

• New US/EU Transatlantic Task Force on Antimicrobial Resistance and IDSA’s “10 X ’20 Initiative: Two’s Path Forward" 12/04/2009
  Robert Guidos, JD, IDSA VP, Public Policy & Government Relations, outlines IDSA’s position in an invited guest column of the Center for Global Development’s newsletter. 
• Hospital and Societal Costs of Antimicrobial-Resistant Infections in a Chicago Teaching Hospital: Implications for Antibiotic Stewardship 10/15/2009 Roberts et al; Published in Clinical Infectious Diseases [CID 2009:49 (15 October)].
• Antibiotic Resistance: Who Will Pay the Bills? 10/15/2009 Zaoutis, Theoklis; Published in Clinical Infectious Diseases [CID 2009:49 (15 October)].
• The bacterial challenge – time to react 09/17/2009
  The technical report on the lack of new antibacterials from European Medicines Agency (EMEA)-European Centre for Disease Prevention and Control (ECDC) in collaboration with ReAct.
• IDSA, American Thoracic Society, American College of Chest Physicians, Society for Critical Care Medicine, and the U.S. Food and Drug Administration Co-Sponsor a March 31 – April 1, 2009 Public Workshop on Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia
• A Review of Recent Federal Actions that Impact Antimicrobial Drug Research, Development and Use, and the Infectious Diseases Society of America’s (IDSA) Recent Efforts and Successes (PPT) 03/05/2009 Presentation by Robert J. Guidos, JD, IDSA Director Public Policy & Government Relations at the 6th Anti-infectives Partnering and Deal-Making Summit
• Bad Bugs, No Drugs/Strategies to Address Antimicrobial Resistance Act: Our Advocacy Campaign  (PPT) 10/24/08
  Presentation by Robert J. Guidos, JD, IDSA Director Public Policy & Government Relations before the Society of Infectious Diseases Pharmacists
• IDSA/FDA CAP Workshop Transcript Now Online, http://www.fda.gov/Drugs/NewsEvents/ucm180241.htm, 03/20/2008 From January 17-18, 2008 Workshop on CAP Clinical Trial Designs 
• IDSA and the U.S. Food and Drug Administration Sponsor January 17-18, 2008 Public Workshop on Clinical Trial Design for Community-Acquired Pneumonia (PDF) 01/17/2008
   See Federal Register Notice (PDF) and Workshop Program (PDF).
• "Fighting Superbugs" CQ Researcher Supplement, Reprinted with permission from CQ Press 9/7/07
• Senate Accepts Hatch Provision to Expand Antibiotic Research 5/8/07
  Press release and transcript of the floor speech by Senator Orrin Hatch on the inclusion of provision in the FDA Revitalization Act which would expand antibiotic research.
• Facts about Antibiotic Resistance
• Facts About the Antibiotic R&D Pipeline: Why Antibiotics Require Special Treatment
• Animation of Antimicrobial Resistance
  Produced by the Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM)
• Healthy Body, Healthy Mind; "Antibiotic Resistance: Stopping Superbugs"
  Information Television Network program

Relevance of the FDA's Orphan Drug Act to Antibacterial R & D

• IDSA Requests FDA to Clarify Its Orphan Drug Act and Resistant Infections Policy 07/18/2008
  The Society's letter seeks clarification on inconsistent statements made by agency officials about the relevance of the Orphan Drug Act to resistant infections and asks whether a parallel regulatory framework with incentives similar to, but not the same as, the Orphan Drug program could stimulate antibacterial drug, and related diagnostic and vaccine, research and development.
• 2nd IDSA Letter to FDA Concerning the Orphan Drug Act 08/28/2008
  Continuing its dialogue with FDA on the relevance of the Orphan Drug Act to serious infections caused by resistant organisms, IDSA met with FDA officials on August 25th.  This letter summarizes key points raised during that meeting and seeks FDA's confirmation of these points.
• FDA's Response to IDSA's Letters of July 18 and August 28, 2008 10/15/2008

Images

• Bad Bugs Need Drugs: Image Gallery (PDF)
  Electron micrograph images of the six bugs from the Hit List

Articles Published in Clinical Infectious Diseases

• Antimicrobial Agents for Complicated Skin and Skin-Structure Infections: Justification of Noninferiority Margins in the Absence of Placebo-Controlled Trials, Spellberg et al 8/1/2009 (See also Accompanying Editorial by Dennis Stevens)
• Bad Bugs, No Drugs, No ESKAPE: An Update by IDSA (the state of the antibiotic pipeline); Boucher et al 1/1/2009
• Position Paper: Recommended Design Features of Future Clinical Trials of Antibacterial Agents for Community-Acquired Pneumonia, IDSA 12/01/08
• IDSA-FDA Community-Acquired Pneumonia Workshop Supplement, Table of Contents 12/01/08
• The Epidemic of Antimicrobial Resistant Infections: A Call to Action for the Medical Community from the Infectious Diseases Society of America January 15, 2008, Spellberg et al 1/15/2008
• Bad Bugs Need Drugs: An Update on the Development Pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America (PDF), Talbot et al 3/1/2006
  This article contains the Bad Bugs "Hit List".
• Changes in the Epidemiology of Methicillin-Resistant Staphylococcus aureus in Intensive Care Units in US Hospitals, 1992–2003 (PDF) 2/1/2006
  R. Monina Klevens, Jonathan R. Edwards, Fred C. Tenover, L. Clifford McDonald, Teresa Horan, Robert Gaynes, and the National Nosocomial Infections Surveillance System
• Prevalence of Staphylococcus aureus Nasal Colonization in the United States, 2001–2002 (PDF) 1/15/2006
  Matthew J. Kuehnert, Deanna Kruszon-Moran, Holly A. Hill, Geraldine McQuillan, Sigrid K. McAllister, Gregory Fosheim, Linda K. McDougal, Jasmine Chaitram, Bette Jensen, Scott K. Fridkin, George Killgore, and Fred C. Tenover
• Trends in Antimicrobial Drug Development: Implications for the Future 3/7/2004
  Brad Spellberg, John H. Powers, Eric P. Brass, Loren G. Miller, and John E. Edwards, Jr.