Hundreds of antimicrobial products will no longer be approved for livestock production uses, such as increased weight gain, by the end of 2016.
The affected drugs will be available only to treat, control, or prevent specific diseases through a prescription or veterinary feed directive, which is similar to a prescription. The change will affect about 280 drug approvals, each of which can include multiple products.
The Food and Drug Administration announced Dec. 11, 2013, that drug companies had three months to provide notice whether they intended to follow an agency plan to, within three years, eliminate production uses of antimicrobials deemed to be important for human medicine and eliminate the over-the-counter availability of those drugs. In late March, the agency announced that 25 of the 26 affected companies had agreed to comply, which will involve withdrawal of drug approvals that allow administration of the antimicrobials to livestock for uses such as improving growth rates.
FDA information indicates drug companies already had consented to withdrawal of more than 30 affected antimicrobial approvals by late April.
The FDA intends to reduce the risk that such antimicrobial uses will select for bacteria resistant to drugs needed to treat people.
The Norway-based Pharmaq AS is the only company listed as affected by the FDA’s plan and not listed as agreeing by the March 12 deadline to comply, according to FDA documents. Morten Kr. Nordstad, CEO of Pharmaq, provided a statement that his company does not claim its antimicrobial products can be used to promote livestock growth, and, for that reason, did not think the FDA’s proposed voluntary program was relevant for Pharmaq products.
“Pharmaq is, however, clearly supporting all initiatives to minimize the use of antibiotics in both livestock and aquaculture,” he said. “We will therefore quickly review the FDA request again and carefully consider joining this valuable initiative from the U.S. authorities.”
The FDA documents indicate Pharmaq owns the drug approval for Romet 30, an ormetoprim and sulfadimethoxine medicated feed product currently available over the counter, with indications for treating furuncolosis in salmonids and enteric septicemia in catfish.
Megan Bensette, an FDA spokeswoman, said the FDA mailed letters to all affected drug sponsors on Dec. 12, 2013, and all companies had responded to the FDA by March 12.
FDA authorities have warned that, while they want voluntary action by drug companies, they will consider regulatory action against any that do not comply.
Dr. Ron DeHaven, AVMA CEO, said in an announcement that the AVMA was pleased to see so many companies listed as participating in the FDA’s voluntary program “for the greater good of animals and people.”
“The AVMA has long advocated that judicious use of antimicrobials and greater veterinary oversight on the farm benefit human and animal health,” Dr. DeHaven said in the announcement. “The FDA’s list serves as confirmation that the voluntary process is one that can produce positive results.”
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