US: FDA Won?t Act Against Ag Antibiotic Use

[Gert van der Hoek]

News: FDA Won’t Act Against Ag Antibiotic Use

By Maryn McKenna December 23, 2011

With no notice other than a holiday-eve posting in the Federal Register, the US Food and Drug Administration has reneged on its long-stated intention to compel large-scale agriculture to curb over-use of agricultural antibiotics, which it had planned to do by reversing its approval for putting penicillin and tetracyclines in feed.

How long-stated? The FDA first announced its intention to withdraw those approvals in 1977.

From the official posting:

The Food and Drug Administration (FDA or the Agency) is withdrawing two 1977 notices of opportunity for a hearing (NOOH), which proposed to withdraw certain approved uses of penicillin and tetracyclines intended for use in feeds for food-producing animals based in part on microbial food safety concerns.1 … (1FDA’s approval to withdraw the approved uses of the drugs was based on three statutory grounds: (1) The drugs are not shown to be safe (21 U.S.C. 360b(e)(1)(B)); (2) lack of substantial evidence of effectiveness (21 U.S.C. 360b(e)(1)(C)); and (3) failure to submit required reports (21 U.S.C. 360b(e)(2)(A)).)

There is a lot of background to this, but here is the takeaway: For 34 years, the FDA has been contending that administering small doses of antibiotics to healthy animals is an inappropriate use of increasingly scarce drugs — a position in which it is supported by organizations as mainstream as the American Medical Association. With this withdrawal, it backs away from the actions it took to support that assertion — and may indicate there will be no further government action on the issue until after the 2012 election.

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