Bringing all medically important antimicrobial drugs approved for use in animals under veterinary oversight and promoting proper stewardship of antimicrobials are among the goals of a five-year plan released by the Food and Drug Administration’s Center for Veterinary Medicine on Friday.
The plan was released along with a larger strategy for fighting antimicrobial resistance announced by FDA Commissioner Scott Gottlieb, including, he said, “facilitating product development to ensure a robust pipeline of safe and effective treatments that can combat resistant organisms.”
Gottlieb told an audience at Pew Charitable Trusts, which has produced reports on antimicrobial resistance, that FDA largely has succeeded in ensuring that about 95 percent of the total quantity of medically important antimicrobial drugs approved for use in animals are not used for growth promotion, a development he called “significant public health progress.”
But he said FDA plans to work with industry to bring the remaining 5 percent of drugs, such as certain injectable antimicrobials, under veterinary oversight. FDA plans to release a draft strategy by the end of fiscal year 2019, “likely as a guidance document, to assist industry in making needed changes to their products,” Gottlieb said.
FDA also wants to make sure that medically important antimicrobials carry labels with “appropriately defined durations of use,” the commissioner said.
About 40 percent of approved medically important antimicrobial drugs used in feed and water of food-producing animals “include at least one indication that doesn’t have a defined duration of use,” Gottlieb said. FDA will release a draft strategy – again, likely as a guidance document – by the end of fiscal year 2020 to craft appropriate use durations.
“CVM has already begun to gather information on this issue and intends to develop and implement a specific strategy for ensuring that all medically important antimicrobial drugs used in food-producing animals are labeled with an appropriately targeted duration of use,” according to its five-year plan.
Animal stewardship also is a key part of the CVM strategy. Gottlieb said FDA would be working with producer groups to provide information on stewardship and with veterinary medical associations and academic institutions “to create veterinary curricula with the most up-to-date information available.”
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CVM also plans to do a better job of collecting data on antimicrobial drug use and increasing the exchange of among stakeholders to help monitor antimicrobial drug use practices and resistance.
One area CVM wants to explore is antimicrobial resistance among companion animals, or pets.
In its plan, the center said it would work with stakeholders “to develop and implement a strategy to promote the judicious use of medically important antimicrobials in companion animals to help preserve the effectiveness of medically important antimicrobials for humans and companion animals. This includes a strategy to address potential development of antimicrobial resistant bacteria in companion animals.”
National Pork Producers Council spokesman Dave Warner said it would be reviewing the plan’s details “and look(s) forward to working with FDA to find science-based solutions to issues raised.”
Mae Wu, a senior attorney in the Natural Resource Defense Council’s health program, said that if FDA really wants to prevent antibiotics from being used for growth promotion, it should require the drugs only be used in disease treatment, not prevention.
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