<br><br>
<div>
<div><font face="Arial">
<table cellspacing="1" cellpadding="2" width="99%" align="center" border="0">
<tbody>
<tr>
<td nowrap align="middle"><font color="#065a9a"><b>CVM:
No Inconsistency on Food Animal Antibiotics</b></font></td></tr>
<tr>
<td nowrap align="middle"><font color="red">01/11/2012</font></td></tr>
<tr>
<td> </td></tr>
<tr>
<td><font face="Verdana"><font face="Verdana"><font face="Verdana"><font face="Verdana"><font face="Verdana">
<blockquote dir="ltr" style="MARGIN-RIGHT:0px">
<div style="MARGIN:0in 0in 0pt">Notwithstanding <a href="http://www.fdaweb.com/login.php?sa=v&aid=D5120460&searchWords=penicillin&cate=S&stid=%241%24se5.F0..%24oOqV8vsSusJCELnlYRlyd." target="_blank">published
criticism</a> 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
<b>Bill Flynn </b>told <b><i>FDA Webview</i></b>
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.</div>
<div style="MARGIN:0in 0in 0pt"> </div>
<div style="MARGIN:0in 0in 0pt">Confusion about CVM’s bifurcated
approach arose from “less than ideal” timing of <b>(1)</b> a
<i>Federal Register</i> notice <a href="http://www.fdaweb.com/login.php?sa=v&aid=D5120350&searchWords=penicillin&cate=S&stid=%241%24se5.F0..%24oOqV8vsSusJCELnlYRlyd." target="_blank">withdrawing
a 34-year-old notice</a> of opportunity for a hearing on FDA proposals
to ban subtherapeutic uses of penicillin and tetracycline, and 12 days
later, <b>(2)</b> <a href="http://www.fdaweb.com/login.php?sa=v&aid=D5120410&searchWords=cephalosporin&cate=S&stid=%241%243g0.OR..%24OFv37umBroETTJ8fZC9yT1" target="_blank">issuance
of an order</a> banning certain off-label therapeutic uses of
cephalosporin.</div>
<div style="MARGIN:0in 0in 0pt"> </div>
<div style="MARGIN:0in 0in 0pt">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 <a href="http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf" target="_blank">6/28/10
draft guidance</a>, <i>The Judicious Use of Medically Important
Antimicrobial Drugs in Food-Producing Animals. </i>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.”</div>
<div style="MARGIN:0in 0in 0pt"> </div>
<div style="MARGIN:0in 0in 0pt">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.”</div>
<div style="MARGIN:0in 0in 0pt"> </div>
<div style="MARGIN:0in 0in 0pt">FDA’s action against off-label uses of
cephalosporin is “an additional step,” Flynn told <b><i>FDA
Webview</i></b> and draws its authority from <a href="http://www.nrsp-7.org/Legislation/AMDUCA.pdf" target="_blank">21 CFR 530</a>, the
same authority CVM used 15 years ago to <a href="http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm127904.htm" target="_blank">curb
misuse of fluoroquinolones</a> in food animals.</div>
<div style="MARGIN:0in 0in 0pt"> </div>
<div style="MARGIN:0in 0in 0pt">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.</div>
<div style="MARGIN:0in 0in 0pt"> </div>
<div style="MARGIN:0in 0in 0pt">“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.</div>
<div style="MARGIN:0in 0in 0pt"> </div>
<div style="MARGIN:0in 0in 0pt">“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</div></blockquote></font></font></font></font></font></td></tr></tbody></table></font></div></div>
<br><br clear="all"><br>-- <br>Stevan Gressitt, M.D.<br>Faculty Associate, University of Maine Center on Aging<br>Academic Member, Athens Institute for Education and Research<br>Athens, Greece<br>Founding Director, International Institute for Pharmaceutical Safety<br>
University of New England, College of Pharmacy<br>Department of Pharmaceutical Sciences<br>Associate Professor of Clinical Psychiatry<br>University of New England, College of Osteopathic Medicine<br>314 Clark Road<br>Unity, Maine, 04988<br>
<a href="mailto:gressitt@gmail.com" target="_blank">gressitt@gmail.com</a> <br>Cell: 207-441-0291<br><a href="http://www.benzos.une.edu" target="_blank">www.benzos.une.edu</a><br><a href="http://www.safemeddisposal.com" target="_blank">www.safemeddisposal.com</a><br>