Antibiotic Development: The 10 x '20 Initiative

IDSA Refutes PASTEUR Myths

Letter covers antibiotics clinical trial issues, including superiority data, enrollment and policies to ensure clinically meaningful novel antibiotics.

IDSA leads over 200 organizations in support of PASTEUR Act

Diverse coalition of organizations representing clinicians, patients, scientists, public health and industry urge Congress to enact PASTEUR as part of the Pandemic and All Hazards Preparedness Act reauthorization.

IDSA leads over 160 groups in support of PASTEUR Act

Diverse coalition of organizations representing clinicians, public health, patients, advocates and industry urge Congress to enact PASTEUR.

IDSA Urged PASTEUR Enactment this Year

IDSA led a letter signed by over 90 organizations urging HHS Secretary Becerra to call on congressional leaders to pass PASTEUR this year.

IDSA Urges PASTEUR Enactment this Year

IDSA led a letter signed by over 90 organizations urging HHS Secretary Becerra to call on congressional leaders to pass PASTEUR this year.

Cures 2.0 Thank You Letter to Sponsors

IDSA thanks Cures 2.0 Sponsors for Including PASTEUR: IDSA led 40+ organizations in thanking Reps. DeGette (D-CO) and Upton (R-MI) for including AMR legislation—the PASTEUR Act—in the broader Cures 2.0 legislative package.

IDSA Co-leads Push for AMR Congressional Hearing

IDSA, The Pew Charitable Trusts, and more than 50 organizations urge a congressional hearing on AMR and the PASTEUR Act.

Local IDSA Members Urge Rep. Eshoo (D-CA) to Hold AMR Congressional Hearing

Over 45 IDSA members in northern CA requested that the House Health Subcommittee Chair Hold a Hearing on AMR and the PASTEUR Act.

IDSA Comments on Cures 2.0 Draft Bill

IDSA provides feedback on draft bill including pandemic preparedness, antimicrobial resistance, immunizations, telehealth, research and more.

IDSA leads letter urging advancement of PASTEUR Act

IDSA led a letter signed by 50 organizations urging the Senate Health Committee to include the PASTEUR Act in broader pandemic preparedness legislation.

IDSA Letter to Senator Todd Young RE DISARM Act

IDSA urges Senator Todd Young (R-IN) to become a lead cosponsor of the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, S. 1712.

IDSA and Others Support the DISARM Act (PDF)

IDSA joined groups representing health care providers, scientists, patients, public health, advocates, and industry, wrote to offer support for the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act (S.1719).

IDSA Support Letter Re DISARM Act (PDF)

IDSA supports the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act.

IDSA and Others Urge Congress to Enact Package of Incentives to Reinvigorate Antibiotic Pipeline (PDF)

IDSA and other organizations signed onto a letter urging Congress to enact a package of incentives to reinvigorate the antibiotic pipeline while ensuring patient access and appropriate stewardship.

IDSA Applauds Introduction of the Re-Valuing Anti-Microbial Products Act (PDF)

IDSA applauds the introduction of the Re-Valuing Anti-Microbial Products (REVAMP) Act, which would provide an important economic incentive for the research and development of urgently needed new antibiotics.

IDSA Comments to Senate HELP on PAHPAI Discussion Draft (PDF)

IDSA comments to Senate HELP Committee leaders on the draft Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPAI), which reauthorizes and strengthens the Pandemic and All-Hazards Preparedness Act.

IDSA Leads Support for READI Act (PDF)

IDSA and over forty other organizations representing healthcare providers, hospitals, pharmacists, scientists and microbiologists, industry, public health experts, patients and advocates expressed support for the Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act.

IDSA Shares New Drug Shortages Survey Data on Anti-Infective Drugs with Congressional Leaders (PDF)

IDSA shared new data from a 2016 Emerging Infections Network (EIN) survey on anti-infective drug shortages with leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House of Representatives' Energy and Commerce Committee.

IDSA Urges Congress to Approve Antibiotic and Workforce Provisions in Cures Act (PDF)

As the House prepared to vote on a new version of the 21st Century Cures Act, IDSA wrote in support and highlighted the provisions addressing antibiotic R&D, the future research workforce, and the opioid epidemic as essential.

IDSA Engages House Subcommittee Ahead of Hearing on Antibiotic Resistance (PDF)

In advance of a hearing on federal efforts to address antibiotic resistance, IDSA wrote to leaders of the Subcommittee to urge support for implementation of the National Action Plan for Combating Antibiotic-Resistance Bacteria. The letter placed particular emphasis on antibiotic stewardship, incentives to spur R&D, ID workforce challenges, and the need for increased funding for federal AR programs.

IDSA Leads Health Groups in Supporting Defense Bill Amendment on Antibiotic R&D (PDF)

Forty groups joined an IDSA letter urging senators to vote in favor of a defense bill amendment that would approve a limited population antibacterial drug (LPAD) pathway.

IDSA Endorses House Bill Aimed at Preventing Antibiotic-Resistant Infections (PDF)

Representative Ted Lieu (D-CA) introduced the Preventing Superbugs and Protecting Patients Act, clarifying which reusable medical devices must include validated cleaning instructions as part of a pre-market submission to the FDA. IDSA wrote in support of the bill as one of several steps needed to help prevent the spread of antibiotic-resistant bacteria.

IDSA Engages Senate Health Committee Ahead of Key Biomedical Innovations Mark-Up (PDF)

As the Senate’s health committee prepared to begin considering bills included in their biomedical innovations package, IDSA wrote to leaders in support of those that promote the research workforce and slow the spread of infectious diseases. IDSA urged the committee to also include legislation to provide a limited population antibacterial drug approval pathway, as advanced in the House-passed 21st Century Cures Bill.

IDSA Leads Stakeholders in Support of R&D Tax Credit for Antibiotics and Rapid Diagnostics (PDF)

Forty groups representing providers, patients, public health, and industry joined a letter circulated by IDSA supporting the Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act, HR 3539. The READI Act provides an R&D tax credit for antibiotics and antifungals that treat a serious or life-threatening infection where there exists an unmet medical need as well as for rapid infectious diseases diagnostics.

Stakeholder Groups Urge Senate Committee to Include Antibiotic R&D Proposal in Medical Innovations Bill (PDF)

IDSA led a letter of support, which included 36 groups, that urged the Senate committee that oversees health policy to include a limited population antibacterial development (LPAD) pathway in a medical innovations bill that is currently under development. The LPAD provision was included in the House's 21st Century Cures Act that passed with an overwhelming margin in July, 2015.

IDSA Urges Members of Congress to Support 21st Century Cures Bill (PDF)

Ahead of a vote of the full House, IDSA President Dr. Stephen Calderwood wrote to representatives asking that they support the 21st Century Cures bill. Among its many provisions, the legislation establishes a $10 billion NIH Innovation Fund, increases the NIH loan repayment maximum to $50,000, and establishes a new FDA approval pathway for antibiotics to treat serious and life-threatening infections where there is an unmet medical need.

IDSA Responds to Senate Report on Medical Innovation (PDF)

As the 114th Congress got underway, Senators Richard Burr (R-NC) and Lamar Alexander (R-TN) released a report on policy changes necessary to accelerate medical innovation. IDSA praised the effort and detailed proposals that would spur R&D for new antibiotics and rapid diagnostics.

IDSA Provides Input on Initial 21st Century Cures Draft Bill (PDF)

Upon release of draft legislation from the House 21st Century Cures Initiative, IDSA provided detailed input on a variety of issues from R&D for new antibiotics, diagnostics, and vaccines to access to care and workforce training.

IDSA Endorses Legislation to Incentivize R&D for New Antimicrobials (PDF)

IDSA wrote in support of the reintroduction of the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, which incentivizes research and development for the most urgently needed new antimicrobial drugs through increased Medicare reimbursement.

IDSA Joined by Stakeholder Groups in Support of Senate Antibiotic Pathways Bill (PDF)

IDSA and 38 other groups joined in a letter supporting the Promise for Antibiotics and Therapeutics for Health (PATH) Act, which would establish a new limited population antibacterial drug approval pathway for antibiotics to treat serious or life-threatening infections for which there exists an unmet medical need. The legislation was introduced by Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO).

IDSA Endorses Senate Bill Establishing New Antibiotic Approval Pathway (PDF)

On December 10th, Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced a bill to establish a limited population approval pathway for antibiotics to treat serious and life-threatening infections where there is an unmet medical need. IDSA endorsed the bill, which is a companion to the Antibiotic Development to Advance Patient Treatment (ADAPT) Act that is being considering in the House.

IDSA Responds to House Inquiry on Patient Perspectives on Lack of Treatments (PDF)

As part of its 21st Century Cures initiative launched in May 2014, the House Energy and Commerce Committee requested input on how a lack of treatments is impacting patients and steps that can be taken to speed related R&D. IDSA responded to the inquiry and stressed the need to advance proposals aimed at repairing the pipeline for new antibiotics.

IDSA Responds to House Request for Input on Innovation in Drug R&D (PDF)

IDSA provided input on how proposals in the 2012 President's Council of Advisors on Science and Technology (PCAST) Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation can contribute to new cures. The House Energy & Commerce Committee request for input is a part of their 21st Century Cures initiative.

Stakeholder Groups Call for Action on ADAPT Act through 21st Century Cures Initiative (PDF)

In a letter to the House Energy & Commerce Committee, which as jurisdiction over health issues, 22 organizations called for swift consideration of the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, which establishes a limited population antibacterial drug (LPAD) approval mechanism. The letter asks that ADAPT be moved immediately as part of the Committee's new 21st Century Cures initiative.

IDSA Members Call on Congress to Advance LPAD Pathway

131 IDSA members joined in a letter to the House Energy & Commerce Committee urging prompt consideration of the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, which establishes a limited population antibacterial drug (LPAD) approval mechanism. The letter responds to a request from the Committee seeking input on proposals to spur drug R&D.

IDSA Engages House 21st Century Cures Initiative (PDF)

In May, the House of Representatives launched its 21st Century Cures Initiative aimed at engaging stakeholders to develop policies that will help bring new drugs to market. In response to a request for input, IDSA highlighted the need for new incentives and regulatory changes to spur R&D for new antibiotics and rapid diagnostics as well as public health interventions to slow the rise of resistance.

IDSA Letter on Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act (PDF)

IDSA supports the DISARM Act and requests a modification to the bill to better track use of antimicrobial drugs - the Medicare New Technology Add-on Payment (NTAP) program would provide a new supplemental payment for certain antimicrobial drugs to help incentivize antimicrobial R&D.

IDSA and Others Applaud Introduction of ADAPT Act (PDF)

IDSA and over thirty organizations representing healthcare providers, hospitals, pharmacists, clinical laboratory scientists and medical microbiologists, public health experts, patients and advocates applaud the introduction of the Antibiotic Development to Advance Patient Treatment (ADAPT) Act. The ADAPT Act would speed patient access to new drugs that treat serious, life-threatening infections where an unmet medical need exists.

IDSA Calls on President Obama to Fulfill SOTU Pledge on Antibiotic Resistance (PDF)

IDSA applauds President Obama for highlighting the need to address resistance during his State of the Union address and urges him to take specific actions, including incentivizing development of new antibiotics and diagnostics, strengthening stewardship, improving surveillance, and investing in research.

IDSA Presents at FDA UTI Antimicrobial Drugs Workshop

IDSA AMR Committee Vice Chair Neil Clancy, MD, focuses on UTI studies as path to development of drugs for unmet needs, clinically relevant endpoints, role of stewardship and economic incentives.

IDSA Advocates for ID Inclusion in Cancer Moonshot Initiative

IDSA wrote to NCI Director on the need for ID experts, new antibiotics and stewardship to reduce cancer deaths.

IDSA Leads Letter to HHS Urging G7 Prioritization of AMR

IDSA, BIO and The Pew Charitable Trusts co-led a letter signed by over 40 organizations urging the US to help prioritize AMR with the G7 to build upon global gains and incentivize antibiotic R&D.

IDSA Letter to Assistant Secretary for Preparedness and Response RE Antibiotic Pipeline (PDF)

IDSA letter to Assistant Secretary for Preparedness and Response (ASPR) on the dire state of the antibiotic pipeline and the growing crisis of antimicrobial resistance (AMR).

IDSA Letter to FDA RE Antibiotic Pipeline (PDF)

IDSA letter to the US Food and Drug Administration (FDA) on the dire state of the antibiotic pipeline and the growing crisis of antimicrobial resistance (AMR).

IDSA Comments to NIAID Re Strategic Framework for AR R&D

IDSA submitted recommendations to NIAID on their Strategic Framework for Antibacterial Resistance research and development.

IDSA Comments to UN IACG on AMR on Draft Recommendations

IDSA comments to the United Nations Interagency Coordination Group on Antimicrobial Resistance draft recommendations. IDSA supports the IACG draft recommendations and offers perspectives to help emphasize the importance of specific recommendations and ideas to further strengthen and operationalize the recommendations.

IDSA Comments to PACCARB on CARB National Action Plan (PDF)

IDSA submitted recommendations to the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) regarding priorities to include in the next phase of the CARB National Action Plan.

IDSA Comments to HHS Re Antimicrobial Resistance and the National Biodefense Strategy (PDF)

IDSA supports the National Biodefense Strategy, particulary the goals and objectives related to AMR domestically and internationally, and shared policy recommendations to combat AMR.

S-FAR Sign On Letter in Support of AMR Goals and Objectives in National Biodefense Strategy (PDF)

IDSA and 47 other organizations representing health provider and scientific societies, patient groups, public health associations, hospitals and academic institutions, policy expert groups, pharmaceutical and diagnostic companies, and individual centers and programs, applaud the inclusion of antimicrobial resistance in the National Biodefense Strategy and support its AMR goals and objectives.

IDSA Comments to FDA Re Development of New Antibacterial Drugs Active Against MDR Bacteria (PDF)

IDSA submitted comments to help FDA develop a list of regulatory science initiatives for antimicrobial products to strengthen the antibiotic pipeline and bring urgently needed new antibiotics to market.

IDSA Comments to WHO IACG on AMR Discussion Papers and Questions for Input

IDSA comments to the World Health Organization (WHO) Interagency Coordination Group (IACG) on Antimicrobial Resistance to help inform its efforts to optimize use of antimicrobials, effectively communicate AMR messages, and other areas for collaborative work towards global AMR solutions.

IDSA Comments to FDA Re Draft Guidance on LPAD (PDF)

IDSA comments to FDA on the draft guidance Limited Population Pathway for Antibacterial and Antifungal Drugs.

IDSA Comments to FDA and CMS on Antibiotic R&D and Stewardship (PDF)

IDSA comments to FDA and CMS on the urgent need to provide incentives for the research, development, and judicious use of antibiotics to address the threat of antimicrobial resistance.

IDSA Comments to UN Interagency Coordination Group on AMR (PDF)

IDSA comments to the United Nations Interagency Coordination Group (IACG) on Antimicrobial Resistance (AMR) to help inform its efforts to advance comprehensive solutions to AMR, including stimulation research and development for urgently needed new antibiotics and diagnostics, implementing infection prevention and stewardship programs, and strengthening surveillance.

IDSA Introduction to HHS Secretary Azar on ID Priorities (PDF)

IDSA congratulates new HHS Secretary Alex Azar on his appointment and highlights key issues facing patients and public health, including antimicrobial resistance, ID implications of the opioid epidemic, global health security, public health infrastructure and immunizations, research investments, and the ID physician workforce.

IDSA Comments RE HHS FY2018 - 2022 Strategic Plan (PDF)

IDSA comments on the Department of Health and Human Services (HHS) FY2018 - 2022 Strategic Plan.

IDSA Letter of Introduction to ASPR Robert Kadlec (PDF)

IDSA letter of introduction to new Assistant Secretary for Preparedness and Response (ASPR) Dr. Robert Kadlec outlining IDSA priorities.

IDSA Comments to UN Interagency Coordination Group on Antimicrobial Resistance (PDF)

IDSA submitted comments to the Interagency Coordination Group (ICG) on Antimicrobial Resistance (AMR) established by the UN Secretary-General supporting the objectives set forth by the ICG's proposed work plan, and offering suggestions that would strengthen its efforts.

IDSA Introduction to FDA Commissioner Gottlieb (PDF)

IDSA wrote an introductory letter to recently confirmed US Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb offering its support and highlighting the need for new antibiotic research and development and infectious disease diagnostics.

IDSA Highlights Pressing ID Policy Issues for New HHS Secretary (PDF)

IDSA outlines a number of pressing ID policy priorities for new HHS Secretary Dr. Tom Price, including antimicrobial resistance, domestic and global public health programs, infrastructure, and preparedness, biomedical research and innovation, and ID physician workforce issues.

IDSA Recommendations to PACCARB on Antibiotic Resistance Issues (PDF)

IDSA provided recommendations to the Presidential Advisory Council for Combating Antibiotic Resistant Bacteria (PACCARB) on the issues of antibiotic stewardship, infection control, and data collection.

IDSA Recommendations to HHS on Antibiotic and Diagnostic Incentives (PDF)

IDSA submitted recommendations to HHS Secretary Burwell on incentivizing the development of new antibiotics and rapid diagnostics to combat antibiotic resistance.

IDSA Comments on FDA Industry Guidance for Hospital-Acquired and Ventilator-Acquired Bacterial Pneumonia (PDF)

IDSA comments to FDA on the agency's recent final guidance for industry on hospital-acquired and ventilator-acquired bacterial pneumonia (HABP/VABP) clinical trials. IDSA welcomes the agency's progress making clinical trials more feasible and offers recommendations to improve the guidance.

IDSA Comments on FDA Industry Guidance for Community-Acquired Bacterial Pneumonia (PDF)

IDSA comments to FDA on the agency's recent guidance for industry on community-acquired bacterial pneumonia (CABP) clinical trials. IDSA applauds the agency's efforts to make clinical trials more feasible and offers recommendations to improve the guidance.

IDSA Fact Sheet on Antimicrobial Resistance (PDF)

General information on the threat antimicrobial resistance poses to the United States.

IDSA Fact Sheet on the Need for Antibiotic Incentives (PDF)

General information on the need for incentives to develop much needed antibiotics.

IDSA Member Dr. Danny Benjamin Participates in Congressional Briefing (PDF)

Dr. Danny Benjamin, MD, MPH, PhD, of IDSA's Antimicrobial Resistance Committee (ARC) participated in a congressional briefing titled "2014 Antimicrobial Marketplace Conference." The briefing included speakers from medicine, industry, FDA, and Congressional representatives and DISARM Act sponsors Peter Roskam (R-IL) (represented by staff), Danny Davis (D-IL), and ADAPT Act sponsors Phil Gingrey (R-GA) and Gene Green (D-TX). IDSA cosponsored the briefing with the Antimicrobial Innovation Alliance, a coalition of pharmaceutical companies. Dr. Benjamin's presentation focused on the patient perspective and outlined IDSA's policy priorities for combating antibiotic resistance.

033114 IDSA Presentation at AIDAC.pdf

Presentation by Amanda Jezek, IDSA Vice President of Public Policy & Government Relations at a meeting of the U.S. Food and Drug Administration Anti-Infective Drugs Advisory Committee on the need for new antibiotics.

IDSA President Addresses Policymakers (PDF)

IDSA President David Relman, MD, FIDSA, spoke at a CDC/IDSA/Pew Charitable Trusts congressional briefing on antibiotic resistance and the need for new antibiotics.

Bad Bugs Need Drugs: Why Antibiotics Deserve Congress' Attention and Immediate Action (PDF)

IDSA Treasurer Dr. Cynthia Sears speaks to congressional staff about the need for federal government action to address the public health crisis of antibiotic resistance and the dry antibiotics pipeline.

Limited Population Antibacterial Drug (LPAD) One-Page Summary (PDF)

Limited Population Antibacterial Drug (LPAD) Frequently Asked Questions (PDF)

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.

Reviving the Pipeline of Life-Saving Antibiotics: Exploring Solutions to Spur Innovation (PDF)

Proceedings from the joint Pew-IDSA-PhRMA conference on the growing public health threat of antibiotic-resistant infections.