Antibiotic Development: The 10 x '20 Initiative

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) including through the 10x'20 Initiative. The initiative's goal is to build a sustainable antibiotic R&D infrastructure and, in the short-term, to produce 10 new systemic antibiotics by 2020. To this end, 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. >>Read more

4/7/2011

The 10 x ’20 Initiative Inaugural Statement

IDSA and other organizations call for a global commitment to develop 10 new systemic antibiotics by 2020.

2/22/2011

Preserving the Lifesaving Power of Antimicrobial Agents

A commentary in JAMA by IDSA President James Hughes, MD, FIDSA (subscription required).

6/9/2010

IDSA Testimony on Antibiotic Resistance, delivered before the House Energy and Commerce Health Subcommittee (PDF)

Brad Spellberg, MD, FIDSA, presented IDSA's statement at a hearing on “Promoting the Development of Antibiotics and Ensuring Judicious Use in Humans.”

9/29/2010

IDSA Testimony on Medical Countermeasures Enterprise Review (PDF)

Dr. Andy Pavia testified on behalf of IDSA at a September 29, 2010 hearing of the Senate Labor-Health and Human Services-Education Appropriations Subcommittee examining the Public Health Emergency Medical Countermeasures Enterprise review completed by the Department of Health and Human Services in August 2010.

More Statements

12/21/2011

IDSA Comments on FDA Development of Multiplexed Diagnostics (PDF)

FDA sought comments on options being considered for the performance validation of highly multiplexed microbiology/medical countermeasure (MCM) diagnostic devices. In responding to the FDA concept paper, IDSA addressed the clinical and public health need for better infectious diseases diagnostic devices, clinical considerations for device design, and key issues for device validation.

10/26/2011

IDSA/Others Say FDA Must Have Access to Knowledgeable Subject Matter Experts (PDF)

IDSA joined over 75 provider and patient advocacy organizations in urging Senate leaders to eliminate over-the-top conflict of interest requirements that apply only to Food and Drug Administration advisory committees. These requirements tie FDA's hands preventing the agency from hearing opinions from the most knowledgeable experts prior to approving new drugs, vaccines, diagnostics, etc.

10/17/2011

IDSA asks FDA to seek IOM's Help to Address Antimicrobial/Influenza Antiviral Regulatory Issues (PDF)

The Society would like FDA to engage the Institute of Medicine to develop a process for reviewing FDA's current approaches to anti-infective clinical trial designs for both antibacterial and influenza antiviral drugs as the current approach has produced infeasible instructions for industry and continues to stymie new drug development in these critical areas.

5/21/2009

IDSA Comments on FDA Draft Guidance to Industry on Antivirals for Treatment or Prophylaxis of Influenza (PDF)

In its comments, IDSA raised concerns about FDA's proposal to approve new antivirals for influenza based on superiority or dose-ranging trials vs. non-inferiority trials. IDSA also is concerned about FDA's adherence to Pediatric Research Equity Act requirements, which may act as an impediment to drug development in this critical area.

More FDA-Related Efforts

11/22/2011

IDSA Letter to Sponsors of the Generating Antibiotic Incentives Now (GAIN) Act (PDF)

IDSA applauds GAIN sponsors' leadership and encourages new provisions to provide additional exclusivity incentives to spur antibiotic R&D, provide federal leadership to explore options for public private partnerships to focus on early antibiotic discovery research, and ensure appropriate use of antibiotics.

6/15/2011

IDSA Comments on New Legislation, H.R. 2182, the Generating Antibiotic Incentives Now (GAIN) Act (PDF)

The GAIN Act, introduced in the U.S. House of Representatives, provides an excellent starting point for discussing the right combination of incentives necessary to jumpstart novel antibiotic (and related diagnostic) research and development.

11/20/2009

IDSA's Initial Comments on the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) (PDF)

In a letter to President Obama and Swedish Prime Minister Reinfeldt, IDSA supports the new TATFAR, but seeks the creation of an Antibacterial Drug Development Work Group housed at the White House to oversee the development of incentives to spur antibiotic development.

12/17/2007

IDSA Urges Congressional Action on Antibiotic R&D Incentives Before 2007 Ends (PDF)

Congress has the opportunity to enact an incentive to encourage new research on "older" antibiotics, and IDSA is urging them to act.

More Legislative Efforts

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.

8/5/2011

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.

5/22/2011

Stoking the Antibiotic Pipeline (PDF)

Morel and Mossialos; British Medical Journal [BMJ 2010:340 (22 May)]

4/15/2011

New Drugs to Tackle Antimicrobial Resistance

Sharma and Towse, Office of Health Economics

More Background