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.