Saturday, December 24, 2011

Regulators Are Cowed

Wired:
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 — which may indicate there will be no further government action on the issue until after the 2012 election.

In the Federal Register, the FDA says that it plans instead to “focus its efforts for now on the potential for voluntary reform and the promotion of the judicious use of antimicrobials in the interest of public health.” That’s a reference to a draft guidance that the FDA put forward in the summer of 2010, which proposes that large-scale agriculture voluntarily stop using those “subtherapeutic” small doses, and also stop giving any antibiotic doses to animals unless veterinarians prescribe them.
I'm not sure how folks can cry about the regulatory burden, regulators are routinely cowed from acting in the public interest.  Voluntary reform means no change.  I am surprised that EPA finally issued rules on mercury control, those have only been in the works since the '90s at a minimum.  Human health is taking a backseat to the creature comforts of business, and in the end, it won't work out well.

No comments:

Post a Comment