March 04, 2007

The FDA Burden of Proof Shifts

by PG

As part of a general trend in the Bush administration against regulation, the Food and Drug Administration now claims that it must approve antibiotics for use in animals, even ones that are highly controversial for such use due to their "last defense" status for humans, under a guidance document that states on its second page "This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public." Quite possible this seeming contradiction is just due to bad reporting or writing by the Washington Post. Staff writer Rick Weiss states, "[Approval of cefquinome, a fourth-generation cephalosporin] is all but required, officials said, by a recently implemented 'guidance document' that codifies how to weigh the threats to human health posed by proposed new animal drugs."

I can't tell whether Weiss actually read Guidance #152. He quotes public health experts as saying "that the guidance makes it almost impossible to say no to a new animal drug unless it is likely to threaten the effectiveness of an antibiotic that is a critical player against food-borne illnesses ... although it is a highly important drug in human medicine generally -- and although the Infectious Diseases Society of America even recommends it against some food-borne bacteria -- that risk does not count under the terms of Guidance #152." Yet while whether a proposed animal medication includes antimicrobial drugs used to treat enteric pathogens that cause food-borne disease is indeed ranked the most important criterion, following immediately after it is whether the proposed animal medication is the sole therapy or one of few alternatives to treat serious human disease, or the drug is an essential component among many antimicrobials in treatment of human disease. If it's not just my general paranoia about superbugs (exacerbated by a close relative and cancer patient's difficult-to-defeat urinary tract infections) making me hopeful that approval will be derailed, that sounds like language that would keep cefquinome for humans only.

If the FDA is approving cefquinome for cattle because officials sincerely believe that Guidance #152 requires them to do so, then by all means, let us criticize the FDA for its very poor reading skills/ excessive enthusiasm for approving antibiotics for animal use. Guidance #152 in itself, however, seems fairly unexceptionable, which makes the headline "FDA Rules Override Warnings About Drug" unfair to the rules and too kind to the fools interpreting them. Guidance #152 attempts to lay down criteria by which drugmakers will know how to present their case to the agency, but it does not appear to force the FDA to approve any drug that does not clearly raise the first-ranked issue. Perhaps there has been a revision of Guidance #152 that is as catastrophically stupid as the Post article implies it to be, but the version currently posted is not. If the FDA really had said that the burden of proof for safety had shifted such that the agency now must approve any drug whose opponents have not proven it unsafe, that might be a conservative dream come true, one that surely would have raised a bit more furor before now.

March 4, 2007 03:02 AM | TrackBack

This article, to my knowledge, never appeared in the LA newspapers. My mother had to call me from Pittsburgh, PA to tell me what our wonderful gov was up to. I'd swear they're trying to get rid of us all,over a shorter and shorter period of time.

Posted by: M at March 5, 2007 02:19 AM
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