Infectious Diseases Society of America - Antimicrobial Resistance (10 X '20)

Antimicrobial Resistance (10 X '20)

The World Health Organization has identified antimicrobial resistance as 1 of the 3 greatest threats to human health. IDSA has identified antimicrobial resistance as a priority for the organization.

In 2010, IDSA launched the 10 x ’20 Initiative, which seeks a global commitment to create an antibiotic research and development enterprise powerful enough to produce 10 new systemic antibiotics by the year 2020. The initiative was launched as a response to the growing problem of antibiotic resistance and the lack of development of new antibiotics.

According to IDSA, new antibiotic development has slowed to a standstill due to market failure and regulatory disincentives. Antibiotics aren’t as profitable as other drugs (e.g., drugs to treat chronic conditions like diabetes or asthma, which patients take for years). Also, the US Food and Drug Administration has long delayed publishing workable guidance describing how companies should design antibiotic clinical trials. Moreover, once a new antibiotic makes it to market, physicians hold it in reserve for only the worst cases rather than rushing to use it on all their patients due to fear of drug resistance. These economic and regulatory disincentives have made it far too difficult for companies to continue developing new antibiotics. It is estimated that the cost to the U.S. health care system of antibiotic resistant infections is $21 billion to $34 billion each year and more than 8 million additional hospital days.

On May 1, 2011, IDSA published a policy paper titled “Combating Antimicrobial Resistance: Policy Recommendations to Save Lives” in Clinical Infectious Diseases. The paper detailed the organization’s recommendations for specific public policy strategies and research activities needed to promote the best interests of patients and health care professionals. Specifically, the paper urged creation of incentives to support antibiotic research and development; new rapid diagnostic tests to more quickly diagnose patients; greater coordination of government agencies to support surveillance, data collection, research, and prevention and control; and aggressive promotion of the judicious use of currently available antibiotics. IDSA’s policy paper also proposed the creation of an Antimicrobial Innovation and Conservation (AIC) Fee that would help pay for antibiotic R&D and stewardship efforts necessary to make progress against antibiotic resistance.

Throughout 2012, IDSA garnered support of several medical organizations and pharmaceutical companies for a new FDA approval pathway, called the Limited Population Antibacterial Drug mechanism, to address an unmet medical need by speeding up development of antibiotics to treat patients who have serious infections for which therapeutic options are insufficient. The LPAD mechanism would allow for testing a drug’s safety and effectiveness in smaller, shorter, and less expensive clinical trials, similar to the Orphan Drug Program.

In addition to the 10 x ’20 Initiative, IDSA supports legislative and administrative efforts to strengthen the U.S. response to antimicrobial resistance, such as enhanced coordination and leadership, surveillance, prevention and control, and research efforts. IDSA also promotes the establishment of antimicrobial stewardship programs and integration of good stewardship practices in every health care facility across the United States and is working to eliminate inappropriate uses of antibiotics in food, animals and other aspects of agriculture.