**EAST HOLMES VETERINARY CLINIC, INC.**

**5503 CR 120 PO BOX 286**

**BERLIN, OH 44610**

**330-893-2057**

**FAX: 330-893-3651**

**Dr. Eric M. Shaver, DVM Dr. Teresa Hoxworth, DVM**

**Dr. Amity Wise, DVM Dr. Aaron Wise, DVM**

8/22/08

Division of Dockets Management

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

Dear FDA:

In response to the proposed FDA ruling banning the extra label use of
the Cephalosporin class of antimicrobials, several questions and
concerns have arisen in our clinics' discussion of this matter:

1)  Is the cephalosporin resistance model based on human or livestock
    enteric pathogen studies?

2)  Given the relative lack of alternative, effective antibiotics
    available for use in the treatment of enteric livestock pathogens
    i.e. E-coli, and Salmonella, will not the prohibition of the use of
    ceftiofur result in increased animal suffering?

3)  Given that Adspec has been withdrawn from the manufacturing
    channels, will not the cephalosporin

> ban result in producers using OTC products in a possible
> indiscriminant manner without the oversight of a veterinarian? We have
> seen, for example, producers starting to mix and administer L-S 50 and
> feed grade antibiotics to dairy cows as well as more and more gentocin
> resurfacing for use in baby calves. These products are coming through
> unpoliced OTC channels, not ethical ones.
>
> With no effective antibiotics available for enteric pathogens through
> ethical channels, producers will attempt to take matters into their
> own hands, possibly leading to more residue violations.

4)  If livestock are not treated for enteric pathogens, will not the
    relative number of organisms shed

> actually increase resulting in relatively more milk and meat
> contamination?

5)  Perhaps, rather than banning the ELDU of the cephalosporin class, we
    should encourage the

> manufacturer, Pfizer, to perform the studies necessary to get the
> product labeled for the enteric pathogens at the appropriate doses.
> Those of us who deal with these cases on a regular, daily basis,
> understand that Naxcel and Excenel are effective against enteric
> pathogens but only at heightened doses and increased frequency and for
> longer duration than the respiratory label. Responsible use of
> appropriate levels should minimize the development of resistant
> pathogens.

6)  We have many options available for the treatment of respiratory
    disease, but when treating enteric

> pathogens, the list of effective products is very narrow; with Adspec
> leaving the market, the ban on the use of ceftiofur products for
> enteric pathogens will leave us basically defenseless in the food
> animal world. The suffering and loss experienced by calves, lambs,
> kids and dairy cows will be enormous.

Please reconsider this potential moratorium and, rather, lets consider
encouraging the development of responsible protocols for the treatment
of enteric pathogens in livestock. Our needs are enormous, especially
for the treatment of Salmonellosis in lactating dairy animals and for
the treatment of both Salmonella and E. Coli in neonatal calves, lambs,
kids, and pigs. We certainly understand the FDA's concerns, but a
responsible protocol in our minds will drastically reduce the
development of the resistance patterns so greatly feared by both
veterinarians and MD's alike.

Thanks for your consideration.

Sincerely,

Dr. Eric M. Shaver, DVM

Dr. Teresa Hoxworth, DVM

Dr. Amity Wise, DVM

Dr. Aaron Wise DVM