The
World Health Organization has identified
antimicrobial resistance as one of the three 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 are not as profitable as other drugs (e.g., drugs to treat chronic conditions such as diabetes or asthma, which patients take for years). Also, the U.S.
Food and Drug Administration (FDA) 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. In a followed up policy report released on April 17, 2013, titled "10 X '20 Progress – Development of New Drugs Active Against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America", IDSA expressed grave concern over the weak pipeline of antibiotics to combat the growing ability of bacteria, especially the
Gram-negative bacilli (GNB), to develop resistance to antibiotics. Since 2009, only 2 new antibiotics were approved in United States, and the number of new antibiotics annually approved for marketing continues to decline. The report could identify only seven antibiotics currently in
phase 2 or phase 3 clinical trials to treat the GNB which includes
E. coli,
Salmonella,
Shigella and the
Enterobacteriaceae bacteria, and these drugs do not address the entire spectrum of the resistance developed by those bacteria. Some of these seven new antibiotics are combination of existent antibiotics. There are positive signs that the governments and health authorities in US and Europe have recognized the urgency of the situation. Collaborations are formed between the regulatory bodies and pharmaceutical industry with funding and added incentives. The IDSA's prognosis for sustainable R&D infrastructure for antibiotics development will depend upon clarification of FDA regulatory clinical trial guidance which would facilitate the speedy approval of new drugs, and the appropriate economic incentives for the pharmaceuticals companies to invest in this endeavor. == Lyme disease treatment guidelines ==