On Thursday, the National Pork Producers Council submitted comment on the U.S. Food and Drug Administration's proposed action to revoke the approved method for assessing residues of carbadox, an animal drug used in swine for production and therapeutic purposes.
"Carbadox has been effectively used by most pork producers for decades to support animal health, while adhering to the 42-day withdrawal period. Since carbadox is mainly used in pigs at the nursery stage, the 42-day withdrawal period is likely extended to 60 days or more, resulting in an additional safety buffer against residues. Pork producers prioritize the avoidance of violative residues of all animal health products," NPPC explained.
"The removal of carbadox from the marketplace would inevitably increase the use of other antibiotics and increase the likelihood of difficult-to-control antimicrobial resistance in important bacterial pathogens. We believe this to be in direct conflict with the objectives of FDA's Guidance for Industry 213 and the goals outlined in FDA's 2018 five-year plan, including aligning antimicrobial drug product use with the principles of antimicrobial stewardship and fostering stewardship of antimicrobials in veterinary settings," NPPC wrote.
"If FDA has concerns about the method it uses to test carbadox residue, NPPC believes the agency should work with the sponsor to develop and approve a new regulatory method rather than remove this very effective, non-medically important antibiotic," NPPC added.
Carbadox, sold under the Mecadox trade name by Phibro Animal Health Corp., has been approved and sold in the United States for more than 45 years and is a widely used treatment for controlling bacterial diseases in swine, including Salmonella and swine dysentery.