Despite the desperate need for new antibiotics, only one new systemic antibiotic has been approved since IDSA launched its 10 x ’20 initiative in 2010, according to a recent policy update.
Published in Clinical Infectious Diseases earlier this month, the IDSA report identified only seven new drugs in clinical development for the treatment of infections caused by multidrug-resistant Gram-negative bacilli (GNB) and none that address the entire spectrum of clinically relevant GNB resistance. The report’s authors also found a dwindling number of pharmaceutical companies investing in antibiotic research and development (R&D), signaling an urgent need for action to address the problem as rates of multi-drug resistant pathogens continue to rise.
"We're on the precipice of returning to the dark days before antibiotics enabled safer surgery, chemotherapy and the care of premature infants,” IDSA Board Member Helen Boucher, MD, FIDSA, lead author of the report and a member of the Society’s Antimicrobial Resistance Committee, told Yahoo! News. “We’re all at risk."
IDSA’s report also outlines actions needed: new economic incentives to encourage antibiotic R&D, clarification of the Food and Drug Administration’s (FDA) requirements for antibiotic approval, increased research funding, improved infection prevention, and new public health efforts, such as better data collection and surveillance of drug resistance and use of antibiotics. Antibiotic stewardship efforts to preserve the effectiveness of current antibiotics are also needed.
“In the past, the 10 x ‘20 goal would have been considered modest, but today the barriers to approval of nine additional antibiotics by 2020 seem insurmountable,” said Henry Chambers, MD, FIDSA, chair of the Antimicrobial Resistance Committee, in a Society press release. IDSA’s 10 x ’20 initiative calls for the development of 10 new systemic antibiotics by 2020. “Some progress has been made in the development of new antibiotics, but it’s not nearly enough, and we absolutely must accelerate our efforts.”
Momentum continues to build for the Limited Population Antibacterial Drug (LPAD) approval pathway, proposed by IDSA in 2012 to speed the approval of drugs needed to treat the most life-threatening infections for limited groups of patients, and IDSA continues to explore additional solutions, including R&D tax credits and new reimbursement models, with other stakeholders. U.S. Senators Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) recently sent a letter to FDA Commissioner Margaret Hamburg supporting the LPAD concept. In March, Republican leaders in the U.S. House of Representatives also announced their intent to make fixing the antibiotic R&D pipeline a priority for the 113th Congress.
IDSA’s new Member Advocacy Program (MAP) provides a great way for members to make their voices heard on this issue and other critical ID-related public policy priorities (member login required). You can also contact your congressional representatives directly using the Society’s Take Action webpage. (Scroll down to “Urge Congress to Pass Legislation to Spur Antibiotic Discovery,” under More Alerts.)
For more information
IDSA policy report in CID
IDSA’s 10 x ’20 initiative
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