Regulatory Brief

 Prohibiting extralabel use of adamantane and neuraminidase inhibitor anti-influenza drugs in poultry


Formal title: Docket Number [2006-N-0106] New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-InfluenzaDrugs; ExtralabelAnimal Drug Use; Order of Prohibition

 

Summary:

On March 22, 2006 the FDA published a final rule prohibiting the extralabel use of adamantane and neuraminidase inhibitor classes of antiviral drugs in chickens, turkeys, and ducks. The FDA approved the drugs for treating or preventing influenza A in humans.

The FDA published the rule in spite of indicating that it is unaware of ongoing extralabel use of these human antiviral drugs by U.S. poultry producers.

Though the AVMA is supportive of preserving drugs of public health importance, including the specified antiviral drugs, the AVMA believes that the FDA final rule is unnecessary because the drug use that is prohibited has no anticipated application in U.S. commercial poultry production.

Background Documents:

View Federal Register document (PDF)

View AVMA's response to FDA (PDF)

Status:

AVMA responded on April 4, 2006. The final rule becomes effective June 20, 2006.