Jun 3, 2004 (CIDRAP News) The General Accounting Office (GAO) has urged federal agencies to step up their efforts to determine if the use of certain antibiotics in animals endangers human health by making bacteria resistant to those antibiotics. However, the GAO said, the approved drugs reviewed so far are not the ones the FDA considers critically important to human health, and the reviews have taken at least 2 years to complete. “Therefore it may be some time before FDA completes its reviews of critically important drugs in order to determine if enforcement action to protect human health is warranted,” the report says. The agency recommends that the FDA accelerate its reviews of antibiotics that are used in animals and are important for human health. GAO report “Antibiotic Resistance: Federal Agencies Need to Better Focus Efforts to Address Risk to Humans from Antibiotic Use in Animals”http://www.gao.gov/new.items/d04490.pdf The report also notes that the FDA has moved to bar the use of the fluoroquinoline antibiotic enrofloxacin in poultry because of evidence that fluoroquinoline use in animals has caused the transfer of resistant pathogens to humans. However, the drug has remained on the market the past 3 years because the manufacturer has challenged the FDA move. Concerning the need for data, the GAO says federal agencies have expanded their research on antibiotic resistance related to antibiotic use in animals, but it is too early to judge the effectiveness of their efforts to reduce the risk to human health. The FDA, CDC, and USDA have increased their surveillance and research on antibiotic resistance in animals and humans in recent years. The GAO, Congress’s investigative arm, spent a year preparing the report. It was requested by three senatorsOlympia J. Snowe, R-Me.; Tom Harkin, D-Iowa; and Edward M. Kennedy, D-Mass. In addition, the GAO said research on the human health risk is crippled by a lack of data on the types and amounts of antibiotics used in animals. The agency recommended that the US Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) work together to collect the needed information. The USDA and HHS, on reviewing a draft of the GAO report, generally agreed with it, the GAO says. HHS officials said that pharmaceutical companies have the most useful data on antibiotic use in animals. Current regulations would have to be revised to put the data that companies have to report to the FDA in a more useful format for research on antibiotic resistance, the officials said. Mar 18, 2004, CIDRAP News story, “FDA closer to banning enrofloxacin use in poultry” In a report released last week, the GAO said the Food and Drug Administration (FDA) should speed up its risk assessments to determine whether it should restrict the use in animals of antibiotics considered critically important to human health. “Although they have made some progress in monitoring antibiotic resistance, federal agencies do not collect the critical data on antibiotic use in animals that they need to support research on the human health risk,” the report states. In Denmark, collection of detailed data on antibiotics given to animals has enabled scientists to trace the effects on resistant bacteria in humans and to devise strategies to minimize the health risks, the GAO says. The agency recommends that the FDA and USDA together develop and implement a plan to collect the needed data. The report acknowledges that this will cost money but says it should not be excessively expensive, because existing FDA and USDA programs can provide a framework that can be expanded to begin gathering the information. However, the FDA “is not collecting data on antibiotic use in animals, and USDA’s data collection activities are limited to a few swine farms,” the report says. It suggests that the agencies gather information on the types and quantities of antibiotics sold for animals, the purpose of their use (disease treatment or growth promotion), and the species in which they are used. Many studies suggest that the use of antibiotics in animals poses risks to human health, but a few studies indicate that the health risks are minimal, the report says. The document notes that the FDA has laid out a “risk assessment framework” determining the human health risks. The agency is using the framework in reviewing both currently approved animal antibiotics and manufacturers’ applications for approval of new ones. See also: The United States differs from some of its key trading partners in the use of antibiotics in food animals, the report notes. While the United States and Canada allow some drugs that are important in human medicine to be used for growth promotion, the European Union and New Zealand have banned this practice. In addition, the EU plans to ban the use of any antibiotic for growth promotion by 2006. These policy differences have not significantly affected US meat exports so far, but that could change, the report says. The agency concluded that antibiotic-resistant bacteria have been transferred from animals to humans and that this transfer appears to pose significant risks to human health. Some studies have produced evidence of links between changes in antibiotic use in animals and bacterial resistance to antibiotics in humans. Further, genetic studies of bacteria have established that antibiotic-resistant Campylobacter and Salmonella are transferred from animals to humans, the report says.
APPBI Jakarta chapter chairwoman Ellen Hidayat previously said 60 malls in the capital would reopen for business on June 5 and four others would reopen on June 8, in line with the Jakarta gubernatorial regulation on PSBB extension, which will end on June 4.Despite saying businesses should wait for the evaluation, Anies stated that he had prepared a “new normal” guideline if the city administration decided not to extend the PSBB. He went on to say that he had also collaborated with several epidemiologists in developing the “new normal” guideline for Jakartans.“The coverage will range from economic, religious, social and cultural activities so we can live our lives while preventing the spread of the virus,” he said, adding that he would announce the guideline on the same day as the PSBB evaluation results.National Development Planning Agency (Bappenas) chairman Suharso Monoarfa previously stated that Jakarta had the potential to become a model for the “new normal”, saying Jakarta had met the requirements.Suharso said there were three criteria for regions to become a model, namely, their basic reproduction number (R0) of COVID-19 should fall below 1.0 for two consecutive weeks, a bigger maximum capacity of hospital beds for COVID-19 treatment than the number of new cases that require hospital care and a swab test capacity of at least 3,500 per 1 million population.As part of the plan to gradually loosen the PSBB, police and military personnel will be deployed to monitor the situation starting on Tuesday in Jakarta, West Java, West Sumatra and Gorontalo provinces. Read also: Concerns mount over reopening of offices, malls as Indonesia steps into ‘new normal’Up to 340,000 officers will be posted at 1,800 public spaces to enforce the limitation of large gatherings and ensure modes of public transportation and commercial areas operate at only 50 percent capacity, according to Indonesian Military (TNI) commander Air Chief Marshal Hadi Tjahjanto.A shopping mall that can accommodate 1,000 people, for instance, will only be allowed to hold 500 people.Topics : “No regulation has been issued that says the PSBB [in Jakarta] has ended.”Anies added that the reopening date of malls in Jakarta would depend on the results of the third phase of Jakarta’s PSBB evaluation, which would be conducted on Friday. He expected the results to come out early next week.”It could be extended, it could also end. It would neither depend on the government nor experts but the behavior of all of us. If people can control themselves and the virus reproduction level drops to below 1, then the PSBB could end on June 4,” he explained.Read also: ‘I don’t think we can wait’: Business groups ready for ‘new normal’ despite risks Jakarta Governor Anies Baswedan has refuted the Jakarta Indonesian Shopping Center Association’s (APPBI) claim that shopping malls will reopen in early June, citing the potential to extend the capital’s large-scale social restrictions (PSBB).Anies said the third phase of restriction implementation in Jakarta, which will run until June 4, could be extended if deemed necessary. “So if anyone says the malls will open on June 5, that’s made up, it’s fiction,” Anies told the press on Tuesday night.