April 15, 2013

 

 FDA hosting meetings on antimicrobial use

Posted on April 3, 2013






Federal regulators want veterinarians to talk with them about what could happen if the use of some antimicrobials required more veterinarian oversight.

The Food and Drug Administration, with co-sponsorship from the Department of Agriculture, is hosting meetings through June to give livestock owners, veterinarians, and other members of the public opportunities to talk about challenges connected with increasing veterinarian oversight on the use of antimicrobials that are important for human medicine.

The agency wants input as it figures out how to promote judicious antimicrobial use. In its announcement published March 6, the agency indicated that expected changes in antimicrobial availability could cause difficulties among livestock owners who lack access to veterinary services.

“FDA acknowledges that the proposed change in the marketing status of certain antimicrobial drugs to require the involvement of a licensed veterinarian will have practical implications for animal producers and practicing veterinarians,” the announcement states.

In April 2012, the agency published two guidance documents that indicate the agency wants those working with livestock to stop giving their animals feed or water containing antimicrobials important for human medicine, except when those drugs are needed for the animals’ health and a veterinarian issues a prescription or veterinary feed directive. The latter is issued and used in a manner similar to a prescription.

One of the documents published in April 2012 is a draft document that describes goals for withdrawal of approvals for some over-the-counter drug uses and transition of other approvals to prescription or veterinary feed directive uses. The other is a final document aimed at implementing changes in agriculture industries. Both are intended to reduce the risk that antimicrobial use in animals will select for bacteria resistant to those drugs, resistant bacteria will transfer to humans, and the resulting infections will be more difficult to fight.

In the March 2013 announcement, the FDA reiterated that some products currently available over the counter will require prescriptions or veterinary feed directives, and the impact of the change could depend on whether livestock owners have access to veterinary services.

At press time, one meeting was scheduled for April 9 in Bowling Green, Ky. The remaining four meetings are scheduled for April 23 in Olympia, Wash.; May 8 in Fort Collins, Colo.; May 21 in Pierre, S.D.; and June 4 in College Station, Texas. More information is available in a Federal Register notice published March 7 at  www.federalregister.gov under docket number FDA-2012-N-1046.