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November 14, 2018

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IDSA Continues to Press Administration on AMR

 

IDSA continues to be deeply concerned about the ongoing exodus of companies from antibiotic research and development and continued news that small antibiotic companies are facing significant financial struggles.  These developments seriously threaten the already fragile antibiotic pipeline and the discovery and availability of urgently needed new antibiotics.  IDSA issued this news release in response to the most recent news that Achaogen must reduce its operating costs by 35-40 percent.

Amid these challenges, IDSA is grateful that HHS Secretary Azar and FDA Commissioner Gottlieb continue expressing an understanding of the need to strengthen the federal government response to AMR and to support antibiotic research and development.  IDSA is utilizing two current opportunities to urge rapid action on this important issue. 

FDA Regulatory Science Initiatives for Antimicrobial Products

IDSA developed this response to this FDA request for information to help FDA develop a list of regulatory science initiatives for antimicrobial products.  This RFI seeks ideas on research areas where regulatory science can support new antibacterial drug development in general, by creating new drug development tools or standards for use by industry or other stakeholders, to meet patient needs.  IDSA recommendations focus on improving antimicrobial clinical trial enrollment, developing composite endpoints, increasing the use of rapid diagnostic tests in antimicrobial clinical trials, improving the use of PK/PD data, and other topics that would strengthen approaches to antimicrobial R&D.

Biodefense Strategy

IDSA sent this letter to Secretary Azar to commend the inclusion of AMR in the new National Biodefense Strategy.  The strategy includes the following AMR goals:

Reduce the Emergence and Spread of Antimicrobial-resistant Pathogens Domestically and Internationally.

    • Strengthen awareness of drug-resistant pathogens and their associated diseases and improve stewardship of medically important drugs.
    • Strengthen understanding of the drivers of drug resistance and improve the development and adoption of effective mitigation measures.
    • Promote the use of preventive and therapeutic options other than antimicrobial drugs.
    • Accelerate basic and applied research and development of new antimicrobials, novel preventatives and therapeutics, vaccines, and diagnostic tests.

 IDSA offered specific recommendations to advance these goals, including Medicare requirements for the implementation of ID physician-led stewardship programs, increased funding for AMR research and surveillance, and new antibiotic R&D incentives that provide a return on investment for the most urgently needed new antibiotics.

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