Mike the Mad Biologist

Ok, so after complaining about how no one reads my posts on antibiotic resistance, one reader read this post about the FDA overriding an expert panel that advised against using cefquinome in agriculture, and then went and read the recently released minutes of the hearing (all eight gajillion pages). Here’s what the director of the Center for Veterinary Medicine of the FDA said (p. 211; italics mine):

And so from the FDA standpoint, what we did was we said to the company after vetting it through the VMAC, that you will be judged — the microbial safety of your product will be judged based on your ability to satisfy the requirements of Guidance for Industry #152.

And so just listening to the conversation, we may be presented with the dilemma that the companies did what they were asked to do, but the decision was still that it wasn’t safe. And then we were going to have to come back and say what is it that we can do in addition to demonstrate safety. And so, I think this is, although it has been a very, again, enlightening conversation, there is going to be some difficult decisions, I think, that may result as a result of that.

Leaving aside the butchering of the English language (even my grammar doesn’t suck that badly), this sounds like the fix is in. The FDA shouldn’t be asking, “what is it that we can do in addition to demonstrate safety”, it should be protecting the public.

Comments

  1. #1 writerdd
    November 24, 2006

    For whatever it’s worth, I read most of your posts on antibiotic resistance.

  2. #2 gordo
    November 24, 2006

    I actually prefer the earlier version of this post.

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