[Pharmwaste] answer from FDA Fwd: CVM: No Inconsistency on Food Animal Antibiotics

[Stevan Gressitt]

   *CVM: No Inconsistency on Food Animal Antibiotics* 01/11/2012

Notwithstanding published
criticism<http://www.fdaweb.com/login.php?sa=v&aid=D5120460&searchWords=penicillin&cate=S&stid=%241%24se5.F0..%24oOqV8vsSusJCELnlYRlyd.>that
it is using inconsistent policy in dealing separately with therapeutic
cephalosporin and subtherapeutic penicillin/tetracycline use in food
animals, CVM is dealing with both in a consistent, deliberate way, deputy
director for science policy *Bill Flynn *told *FDA Webview* 1/11. Both
cephalosporin and the two older drugs are of concern because of their
importance to human health and their risk for producing resistant organisms
in food products, he said.

Confusion about CVM’s bifurcated approach arose from “less than ideal”
timing of *(1)* a *Federal Register* notice withdrawing a 34-year-old
notice<http://www.fdaweb.com/login.php?sa=v&aid=D5120350&searchWords=penicillin&cate=S&stid=%241%24se5.F0..%24oOqV8vsSusJCELnlYRlyd.>of
opportunity for a hearing on FDA proposals to ban subtherapeutic uses
of
penicillin and tetracycline, and 12 days later, *(2)* issuance of an
order<http://www.fdaweb.com/login.php?sa=v&aid=D5120410&searchWords=cephalosporin&cate=S&stid=%241%243g0.OR..%24OFv37umBroETTJ8fZC9yT1>banning
certain off-label therapeutic uses of cephalosporin.

Contrary to some assumptions, Flynn told us that CVM is working to produce,
”in the coming months,” a new program to bring subtherapeutic uses of
penicillin and tetracycline in food animals into compliance with the
Center’s 6/28/10 draft
guidance<http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf>,
*The Judicious Use of Medically Important Antimicrobial Drugs in
Food-Producing Animals. *This document says: “The use of medically
important antimicrobial drugs in food-producing animals should be limited
to those uses that are considered necessary for assuring animal health” and
that “The use of medically important antimicrobial drugs in food-producing
animals should be limited to those uses that include veterinary oversight
or consultation.”

The main difference between the 1977 strategy and the current one would
seem to be a switch from mandatory to voluntary compliance. Flynn said the
premises on which the proposed ban were based have since become “outdated.”

FDA’s action against off-label uses of cephalosporin is “an additional
step,” Flynn told *FDA Webview* and draws its authority from 21 CFR
530<http://www.nrsp-7.org/Legislation/AMDUCA.pdf>,
the same authority CVM used 15 years ago to curb misuse of
fluoroquinolones<http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm127904.htm>in
food animals.

An agency statement says: “The cephalosporin class of drugs is important in
treating human diseases, such as pneumonia, skin and tissue infections,
pelvic inflammatory disease, and other conditions. It is critical to
preserve the effectiveness of these drugs.

“FDA is concerned that certain extralabel uses of cephalosporins in cattle,
swine, chickens and turkeys are likely to contribute to
cephalosporin-resistant strains of certain bacterial pathogens. If
cephalosporins are not effective in treating human diseases from these
pathogens, doctors may have to use drugs that are not as effective or that
have greater side effects.

“The agency is particularly concerned about the extralabel use of
cephalosporin drugs that are not approved for use in cattle, swine,
chickens and turkeys because little is known about their microbiological or
toxicological effects when used in these food-producing anim




-- 
Stevan Gressitt, M.D.
Faculty Associate, University of Maine Center on Aging
Academic Member, Athens Institute for Education and Research
Athens, Greece
Founding Director, International Institute for Pharmaceutical Safety
University of New England, College of Pharmacy
Department of Pharmaceutical Sciences
Associate Professor of Clinical Psychiatry
University of New England, College of Osteopathic Medicine
314 Clark Road
Unity, Maine, 04988
gressitt at gmail.com
Cell: 207-441-0291
www.benzos.une.edu
www.safemeddisposal.com
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