IDSA News - April 2010 (Plain Text Version)
In this issue:
From the President: Working with our Federal Partners to Address Antibiotic Resistance
IDSA supports a broad strategic framework to address antibiotic resistance—one that encompasses drug development, surveillance, prevention and control, research, appropriate antibiotic use in food animals, and effective antimicrobial stewardship programs for human patients.
IDSA supports a broad strategic framework to address antibiotic resistance. In addition to our new 10 x ’20 initiative, calling for the development of 10 new antibiotics by 2020, IDSA also supports:
We have expanded significantly our outreach to Congress to highlight the problem and potential solutions. (For more about this outreach, see the April issue of IDSA’s Antibiotic Resistance Policy Update.)
As these initiatives more forward, the Society increasingly is teaming up with leading federal agencies that are critical to addressing antibiotic resistance, including the National Institute of Allergy and Infectious Diseases (NIAID), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). Patients, ID physicians, scientists, and public health officials rely on these agencies every day. Each has shown a willingness to work with IDSA on important issues that affect members, patients, and public health.
For example, NIAID is considering IDSA’s concerns about regulatory burdens slowing needed research, which the Society highlighted in a 2009 policy statement and in a letter to NIAID Director Anthony S. Fauci, MD (see related IDSA News article). Officials are examining as well the possibility of expanding the purview of NIAID’s clinical trials networks, a proposal IDSA supported in another letter to the agency (see related IDSA News article.)
In addition, NIAID has begun to offer valuable services for conducting basic and clinical research, including genetic sequencing and genotyping, and preclinical services that will be valuable to industry and academe in the development of new treatments for infectious diseases. (For more information about available resources, visit NIAID’s website and IDSA’s website.)
NIAID, FDA, and IDSA are currently in the process of planning a public workshop focusing on four important research topics:
The goal is to bring together key researchers, regulators, scientists, clinicians, and government officials to discuss how to advance research in these critical areas. IDSA and FDA have also co-sponsored successful workshops focused on clinical trial designs for antibiotics to treat community-acquired pneumonia (CAP), in 2008, and hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), in 2009 (see related IDSA News article). FDA is now working on guidance documents in these and other areas to provide pharmaceutical companies with a viable pathway to drug approval.
IDSA has been a strong advocate for funding research on antibacterial resistance, and it is encouraging that NIAID is again offering funding this year for targeted clinical trials to reduce the risk of resistance and preserve the effectiveness of existing antimicrobial drugs. The agency is currently seeking proposals for studies related to pneumonia, bacteremia, tuberculosis (TB), and non-TB mycobacterial lung infections in non-HIV-infected people. For more information about these funding opportunities (proposals are due July 30), visit NIAID’s website.
In congressional testimony submitted earlier this month, IDSA called on Congress to substantially increase NIAID’s funding for antibacterial resistance and drug discovery and development research, to a total of $500 million in fiscal year (FY) 2011 (see IDSA’s testimony).
IDSA also asked lawmakers to provide at least a $36.25 million boost in FDA’s budget for the agency’s antimicrobial resistance and antibacterial drug review programs, part of a recommended overall increase of $495 million for the agency (see IDSA’s testimony). The increase would include additional funding for FDA’s new regulatory science initiative and for the National Resistance Monitoring System, a national public health surveillance system—both important parts of a comprehensive approach to addressing resistance.
Of course, IDSA also values our collaborative efforts with CDC in the areas of infection control and antimicrobial stewardship, which we have reported on in the past and plan to highlight again in the near future. IDSA has requested that Congress increase CDC’s antibiotic resistance funding to $40 million. IDSA looks forward to further strengthening our partnerships with NIAID, FDA, and CDC and other stakeholders to address the complex, multi-cause antibiotic resistance problem. Working together, we can preserve the lifesaving gift of antibiotics for future generations.