Antibiotic approval signals 10 x '20 Initiative progress
The Infectious Diseases Society of America (IDSA) is pleased to announce progress in the 10 x '20 Initiative as two novel antibiotics, dalbavancin and tedizolid phosphate, have recently been approved by the FDA. IDSA launched the 10 x '20 Initiative in 2010, calling for the development of 10 new systemic antibacterial drugs by 2020. Since that launch, three antibiotics have been approved and pharmaceutical manufacturer Roche has announced plans to invest in the research and development of new antibiotics. While this news is encouraging, we still have a great deal more work to do to combat antibiotic resistance and ensure we have the tools necessary to help the patients who need it the most.
IDSA has long advocated for government action to spur the development of new antibiotics. The Generating Antibiotics Incentives Now (GAIN) Act was an important first step to help reduce the economic barriers to antibiotic R&D and has been an important part of the progress we are able to report today. However, stakeholders agree that further economic incentives are needed. IDSA is promoting the creation of tax credits to spur antibiotic and diagnostic research and development. We also advocate for increased funding for the National Institute for Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) - important sources of funding for antibiotic research.
Significant regulatory challenges exist as well - some of the most dangerous pathogens currently occur in relatively small numbers of patients, which makes it challenging to conduct large-scale clinical trials - and legislation is needed to address these concerns. Specifically, IDSA is calling for action on the bipartisan Antibiotic Development to Advance Patient Treatment (ADAPT) Act, which would allow companies to study new antibacterial drugs to treat serious or life-threatening infections for which there is an unmet medical need. These drugs would be studied in smaller clinical trials and thus receive approval for use of the drug in a limited population.
Addressing the pipeline is only one part of a multi-pronged approach to combating antibiotic resistance. A coordinated federal response, enhanced surveillance and data collection, strengthened research and infection prevention efforts are all needed. IDSA supports stronger funding for the Centers for Disease Control and Prevention (CDC) to lead many of these efforts. In addition, IDSA recommends that antimicrobial stewardship programs led by infectious diseases physicians be implemented at all hospitals and healthcare facilities across the country.