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IDSA, U.S. Health Officials Describe Ways To Respond To Global Threat Of Antimicrobial Resistance

To coincide with World Health Day on Thursday, the Infectious Diseases Society of America (IDSA) released a policy paper with nine recommendations for how to control the “ever-growing threat of antimicrobial resistance,” CIDRAP News reports (Roos, 4/7).

“The way we’ve managed our antibiotics for the past 70 years has failed. Antibiotics are a precious resource, like energy, and we have a moral obligation to ensure they are available for future generations,” IDSA President James Hughes said, according to an IDSA press release. “IDSA has a comprehensive, multifaceted plan to address this crisis, but time is running out. If such measures are not implemented now by Congress, federal agencies and health care providers across the country, an increasing number of lives will be devastated and lost,” he added.

Such recommendations by the group include: creating incentives for antibiotic R&D, supporting R&D for rapid diagnostic tests to quickly identify the source of infections, and creating an “Antimicrobial Innovation and Conservation (AIC) Fee to help pay for drug development and stewardship,” the press release states.

During a press conference to mark the release of the paper, IDSA endorsed two pieces of legislation: the Strategies to Address Antimicrobial Resistance (STAAR) Act, which CIDRAP News writes, “addresses challenges that companies face with the FDA,” and the Generating Antibiotic Incentives Now (GAIN), which “would promote better coordination of federal efforts against drug resistance” (4/7).

FDA, CDC Officials Discuss Role Of Agencies In Preventing, Fighting Antimicrobial Resistance

Also Thursday, U.S. FDA Commissioner Margaret Hamburg acknowledged the role regulators can play in speeding up the drug approval process for antibiotics, Reuters reports (Mogato/Dey, 4/7).

“We need better, more advanced strategies for evaluating the effectiveness of new antimicrobials once they’re in development,” Hamburg said, according to CIDRAP News. “This includes new clinical trial designs that are realistic about constraints. … We also need to modernize our regulatory pathways so we can expeditiously review new antibiotics, diagnostics, and vaccines as they come before us,” she said.

According to the news service, “Hamburg said the FDA is trying to streamline the antibiotic approval process in two ways: early engagement of the review team with the drug sponsor to identify and address important questions, and seeking to apply the ‘the best possible science to the review process,’ which requires a broad partnership with industry, academic, and government scientist” (4/7).

Reuters describes several projects the FDA is working on in the area of antibiotic research and development. According to the news service, “Scientists at the U.S. FDA are studying specific areas such as complicated urinary tract infections and serious bacterial infections to advise the drug industry on how to approach new drug research, Hamburg said. The agency expects to complete that work by early 2012” (4/7).

“People assume that antibiotics will always be there to fight the worst infections, but antimicrobial resistance is robbing us of that certainty and new drug-resistant pathogens are emerging,” CDC Director Thomas Frieden said in a statement released on World Health Day. “It’s not enough to hope that we’ll have effective drugs to combat these infections. We must all act now to safeguard this important resource,” he said.

The statement describes how the CDC, together with the FDA and NIH last month released “a public health action plan [.pdf] laying out 11 key goals to combat antimicrobial resistance in the areas of surveillance, prevention and control, research and product development” (4/7).

A Reuters factbox provides a breakdown of facts about drug resistance (4/7).

Indian Health Officials Dismiss Reports Of NDM-1 In Water Supply 

In related news, TIME’s “Healthland” blog reports that the Indian Health Ministry has “dismissed” the results of a study published in Lancet Infectious Diseases Thursday that found bacteria containing the NDM-1 gene were found in water supplies in New Dehli.

“The environmental presence of NDM-1 gene carrying bacteria is not a significant finding since there is no clinical or epidemiological linkage of this finding in the study area,” V.M. Katoch, director of the Indian Council of Medical Research, said, according to TIME. “Targeting a specific geographical region is totally unscientific as such bacteria is present all over the world,” Katoch added (Melnick, 4/7).

“Bacteria with NDM-1 have caused fatal infections in people hospitalized in India, Pakistan and Bangladesh and in a few foreigners who visited those countries for surgery, but this is the first time they have been found in the environment,” the New York Times adds. “Their presence in water has not caused any known outbreaks of untreatable disease, but experts fear it could, especially in the rainy season” (McNeil, 4/7).

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