FDA Advisory Committee recommends streamlining approval for tools to fight super bugs

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Yesterday the FDA anti-infective drug advisory committee recommended streamlining approval processes for antibiotics that target super bugs. Decades of overtreatment have escalated bacterial resistance to known drugs – super bugs. CDC estimates that 2 million Americans are infected and 23,000 die of infections by antibiotic-resistant bugs annually. The answers are better hygiene, especially in hospitals and other institutions, better stewardship, using antibiotics carefully and only as necessary, and developing new drugs. The FDA is being extremely cautious and thoughtful, using the best data available, delicately balancing the overwhelming need for new tools to fight resistant bugs with ensuring safety and effectiveness. They offered their thoughts, asked probing questions of the committee, and really listened to the answers. There is a marked difference between how thoughtful, deliberative policy is made at the FDA and my experience of how most health policy is made in CT – by intuition, anecdote and very small groups of people with little information.
Today we’ll be considering a new entry into the antibiotic toolbox.