The Pew Charitable Trusts held a one-day conference, “A New Pathway for Antibiotic Innovation: Exploring Drug Development for Limited Populations” on Thursday, January 31, 2013.
As 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. Leaders representing the drug industry, health care providers, government regulators and payors came together to advance this concept and explore its feasibility from a business and public health perspective.
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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after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.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 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 infoNearly nine in 10 Americans recognize that antibiotics are effective treatments for fighting bacterial infections like strep throat, but more than a third mistakenly believe the drugs are also appropriate treatments for viral infections such as the common cold. Test your antibiotics IQ and take the quiz.
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"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.
More infoSince Operations Iraqi Freedom and Enduring Freedom began, many American servicemen and women have been infected with antibiotic-resistant bacteria. While our men and women in uniform increasingly survive severe wounds sustained in combat, their injuries leave them susceptible to life-threatening, hard-to-treat infections. Marine Lance Corporal Jonathan Gadsden’s story reflects the growing need for new antibiotics that can treat these dangerous diseases, against which most drugs are useless.
More infoBacteria have become increasingly resistant to the drugs we've come to rely on. Only a concerted effort can avert a public health crisis.
More infoPassed by Congress on June 26 and signed by President Obama on July 9, the FDA Safety and Innovation Act will increase inspections of foreign manufacturers that supply 80 percent of the ingredients in our pharmaceuticals, putting American companies on the same footing as their foreign competitors. In addition, it requires drug makers to hold their suppliers to high standards.
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