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Nearly a year after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.
More infoAs multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.
More info"As a nation, we need to exercise greater care with our use of antibiotics, in both humans and animals, so that these medications remain effective in treating serious bacterial infections."
More infoThe Pew Health Group and Medtronic, Inc. file a joint letter to the U.S. Department of Health and Human Services urging implementation of the Physician Payments Sunshine Provision, which will require that manufacturers of drugs, devices,biologics or medical supplies report to the agency payments made to physicians and teaching hospitals.
More info"And a new survey out today from the Pew Charitable Trusts and the U.S. Centers for Disease Control and Prevention (CDC) shows 79% of adults know they can harm their own health by taking unneeded antibiotics."
More infoFollowing the deadly superbug outbreak in 2011, a recent report published by the NIH indicates new antibiotics could help fight antibiotic resistant bacteria. Senior Officer of Pew's Antibiotics and Innovation Project Nicole Mahoney discusses the new report and the need for a comprehensive strategy to prevent superbug outbreaks.
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"One of the most urgent global public health problems is the increasing capability of bacteria to resist antibiotic drugs. The crisis of antimicrobial resistance is particularly acute in hospitals, where superbugs able to resist multiple drugs have spawned. More than 70 percent of the bacteria that cause hospital-related infections are already resistant to at least one type of antibacterial drug."
More info"Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market."
More info"Forty-nine states, including Maine, now operate a prescription monitoring program - or are putting one in place - to track the powerful pain medication dispensed by pharmacies. These databases have already helped in the fight to curtail diversion and abuse of prescribed opioids. But the way they operate - and how the data they collect gets used - varies widely from state to state."
More info"As doctors battled a deadly, drug-resistant superbug last year, they turned to an antibiotic of last resort. But colistin, as it’s called, was discovered in 1949. Between 1945 and 1968, drug companies invented 13 new categories of antibiotics, said Allan Coukell, director of medical programs at the Pew Health Group. Between 1968 and today, just two new categories of antibiotics have arrived."
More info''The menace posed by germs resistant to powerful antibiotics was all too apparent when a deadly, drug-resistant form of pneumonia bacteria struck the Clinical Center of the National Institutes of Health last year. It infected 17 patients and killed 6 of them. This disheartening episode shows again the importance of slowing the development of resistant strains by reducing rampant overuse of antibiotics — and of developing new, more effective antibiotics."
More infoOn August 22, researchers at the National Institute of Health released a scientific paper detailing the use of advanced genetic technology to trace a deadly infection, untreatable by nearly every antibiotic, that spread through the NIH’s Clinical Center last year.
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