IDSA : Antibiotic Development: The 10 x '20 Initiative

Statements and Reports (15): 04/17/2013
10 × '20 Progress—Development of New Drugs Active Against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America
The current report updates the status of development and approval of systemic antibiotics for Gram negative bacteria in the United States, as part of The 10 x ’20 Initiative.
03/01/2013
IDSA Statement on Limited Population Antibacterial Drug (LPAD) Approval Mechanism (PDF)
The Society submits comments to the Food and Drug Administration (FDA) on LPAD in response to the Agency's Part 15 hearing.
03/08/2012
IDSA Congressional Testimony on Antibiotic R&D and 2012 PDUFA Legislation (PDF)
In testimony to Congress, IDSA proposed a new approval pathway for anti-infective therapies for serious resistant infections where few treatments are available.
12/13/2011
IDSA Statement for Senate Committee Hearing on Drug Shortages (PDF)
IDSA provided a statement for the record for the Senate Health, Education, Labor and Pensions Committee hearing on drug shortages. IDSA highlighted the serious anti-infective shortages and their impact on patient care and public health, and offered strategies to address this problem.
04/07/2011
Combating Antimicrobial Resistance: Policy Recommendations to Save Lives
Infectious Diseases Society of America, Clinical Infectious Diseases vol. 52 supp. 5 7 April 2011 397-428.
More Statements and Reports
FDA-Related Efforts (30): 03/14/2013
IDSA Comments on Drug Shortages Task Force and Strategic Plan (PDF)
IDSA, with endorsement from the Pediatric Infectious Diseases Society (PIDS), submitted comments to FDA calling for stronger communication between FDA, CDC, the pharmaceutical industry, and health care practitioners to identify actions that can be taken to prevent drug shortages that impact patient care and public health.
12/21/2012
IDSA Comments on FDA Draft Guidance on Developing Drugs for Complicated Intra-Abdominal Infections (cIAI) (PDF)
IDSA praised FDA for several elements of the guidance, including the acceptability of a single adequate and well controlled study with supportive data as evidence of effectiveness, the use of clinical and microbiological endpoints, the noninferiority margin, and the willingness to accept a greater degree of risk where there is a serious unmet need. IDSA asked FDA to reconsider areas of concern, including allowance of a switch to oral administration of drugs and allowance of 48 hours of prior non-trial antibiotics.
12/18/2012
IDSA Comments on Developing a List of Qualifying Pathogens (PDF)
IDSA submitted comments to the FDA regarding the establishment of a list of pathogens that would qualify for new antibiotic and antifungal incentives, including an additional 5 years of exclusivity.
10/15/2012
Recommendations on the Conduct of Superiority and Organism-Specific Clinical Trials of Antibacterial Agents for the Treatment of Infections Caused by Drug-Resistant Bacterial Pathogens
IDSA white paper on the critical need for new pathways to develop antibacterial agents to treat life-threatening infections caused by highly resistant bacteria.
10/11/2012
CTTI Antibacterial Drug Development Workshop Summary
Workshop summary of the Clinical Trials Transformation Initiative (CTTI) on the topic of Anti-Bacterial Drug Development: Issues in the Design of Trials in Patients with Unmet Need and in Patients with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia.
More FDA-Related Efforts
Legislative Efforts (23): 09/19/2012
IDSA Letter to HHS on Antimicrobial Resistance and Immunization Policies (PDF)
IDSA urges Secretary Sebelius to act on Senate recommendations regarding antimicrobial resistance, antibiotic research and development, and immunization policies.
09/07/2012
IDSA Summary of Antibiotic Incentives in the FDA Safety and Innovation Act (PDF)
IDSA summary of antibiotic incentives in the FDA Safety and Innovation Act.
06/19/2012
American Medical Association (AMA) Supports IDSA's Limited Population Antibiotic Drug (LPAD) Proposal (PDF)
The AMA House of Delegates voted to adopt a resolution introduced by IDSA in support of the establishment of the LPAD approval mechanism.
05/07/2012
IDSA Supports House Antibiotics Legislation (PDF)
IDSA sent the House Energy and Commerce Committee a letter of support for the antibiotic provisions included in their bill to reauthorize the Food and Drug Administration (FDA) Prescription Drug User Fee Agreement (PDUFA), and urged the Committee to further strengthen the legislation.
04/24/2012
IDSA Supports Senate Antibiotics Legislation (PDF)
IDSA submitted a letter of support for the antibiotic provisions included in the Senate bill to reauthorize the Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA).
More Legislative Efforts
Background (31): 03/05/2013
CDC's Vital Signs on Carbapenem-resistant Enterobacteriaceae (CRE)
CDC reports on untreatable and hard-to-treat infections from CRE bacteria, which are on the rise. CRE bacteria have become resistant to all or nearly all of the antibiotics we have today.
10/25/2012
Superiority and Organism-Specific Clinical Trials of Antibacterial Agents (PDF)
IDSA presentation at a European Medicines Agency (EMA) workshop on the development pathway of new antibacterials targeting specific multi-drug resistant pathogens representting an unmet medical need.
09/10/2012
Scrip Intelligence Roundtable on Antimicrobial Resistance
In this video presentation, Scrip brought together representatives of key stakeholders, including IDSA, to discuss the risks associated with the emergence of antibiotic resistance and to explore how to avoid returning to a world that fears infection.
06/11/2012
Beyond Gonorrhea: Drug-Resistant Bugs Pose Growing Danger
Pomerance, U.S. News & World Report 11 June 2012.
05/07/2012
Squash 'Superbugs' with Fast-Track Antibiotics Approval
A Bloomberg editorial supporting the Generating Antibiotic Incentives Now (GAIN) Act and FDA "fast track" antibiotics approval pathway to combat the danger of antibiotic-resistant "superbugs."
More Background
Related Websites (5): Restructuring the NIAID Clinical Trial Infrastructure
The National Institute of Allergy and Infectious Diseases (NIAID) is building upon the success of its HIV/AIDS clinical trials networks by creating a new network for antibacterial resistance.
Alliance for the Prudent Use of Antibiotics
APUA is dedicated to improving antibiotic access and use and curbing antibiotic resistance.
ReAct: Action on Antimicrobial Resistance
An independent global network for concerted action on antibiotic resistance, based in Sweden.
British Society for Antimicrobial Chemotherapy's Antibiotic Action Advocacy Campaign
Add your name to BSAC's list of supporters!
Biomedical Advanced Research and Development Authority
Sits within the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.

Antibiotic Development: The 10 x '20 Initiative

Bringing New Antibiotics to Patients Who Need Them

Patient Story : Carlos Don

Patient Story : Brock Wade

Patient Story : Addie Rerecich

Patient Story : David Ricci

The Problem: Antibiotic-Resistant Bacteria

Antibiotic Resistance and You

Urge Congress to Support Antibiotic Research & Development

Endorse the 10 x '20 Initiative

Learn How Antibiotic Resistance is Affecting Your State

Share Your Story

10 × '20 Progress—Development of New Drugs Active Against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America

IDSA Statement on Limited Population Antibacterial Drug (LPAD) Approval Mechanism (PDF)

IDSA Congressional Testimony on Antibiotic R&D and 2012 PDUFA Legislation (PDF)

IDSA Statement for Senate Committee Hearing on Drug Shortages (PDF)

Combating Antimicrobial Resistance: Policy Recommendations to Save Lives

IDSA Comments on Drug Shortages Task Force and Strategic Plan (PDF)

IDSA Comments on FDA Draft Guidance on Developing Drugs for Complicated Intra-Abdominal Infections (cIAI) (PDF)

IDSA Comments on Developing a List of Qualifying Pathogens (PDF)

Recommendations on the Conduct of Superiority and Organism-Specific Clinical Trials of Antibacterial Agents for the Treatment of Infections Caused by Drug-Resistant Bacterial Pathogens

CTTI Antibacterial Drug Development Workshop Summary

IDSA Letter to HHS on Antimicrobial Resistance and Immunization Policies (PDF)

IDSA Summary of Antibiotic Incentives in the FDA Safety and Innovation Act (PDF)

American Medical Association (AMA) Supports IDSA's Limited Population Antibiotic Drug (LPAD) Proposal (PDF)

IDSA Supports House Antibiotics Legislation (PDF)

IDSA Supports Senate Antibiotics Legislation (PDF)

CDC's Vital Signs on Carbapenem-resistant Enterobacteriaceae (CRE)

Superiority and Organism-Specific Clinical Trials of Antibacterial Agents (PDF)

Scrip Intelligence Roundtable on Antimicrobial Resistance

Beyond Gonorrhea: Drug-Resistant Bugs Pose Growing Danger

Squash 'Superbugs' with Fast-Track Antibiotics Approval

Restructuring the NIAID Clinical Trial Infrastructure

Alliance for the Prudent Use of Antibiotics

ReAct: Action on Antimicrobial Resistance

British Society for Antimicrobial Chemotherapy's Antibiotic Action Advocacy Campaign

Biomedical Advanced Research and Development Authority

Antibiotics in the News

Contact Us

Infectious Diseases Society of America