On March 16 the Food and Drug Administration (FDA) issued a draft of an important new regulation to ban the use in poultry of two classes of antiviral drugs. Preserving antivirals for exclusive use in humans will help ensure that when these valuable medicines are needed, as they may be for treating the avian influenza virus, they are more likely to be effective.

UCS and members of the Keep Antibiotics Working coalition played a key role in prompting the FDA to make this decision when they met in January 2006 with Dr. Stephen Sundlof, the head of the FDA's Center for Veterinary Medicine, to urge the agency to take this important step to safeguard public health.

Specifically, the FDA’s order prohibits the extra-label use of anti-influenza drugs adamantane (amantadine and rimantadine) and neuraminidase inhibitor (oseltamivir and zanamivir) in chickens, turkeys, and ducks. Both these classes of drugs are intended for use in humans but prior to this announcement could have been used in animals on an extra-label basis—that is, for uses the FDA did not intend when it approved the drug. Currently many drugs are legally used for extra-label purposes, but overuse of antibiotics and antivirals can cause bacteria and viruses to develop resistance to the drugs. There are no antivirals explicitly approved for treating avian influenza in poultry.

Like antibiotics, antivirals are a powerful therapeutic tool in the fight against disease, but their efficacy can erode when they are used routinely. Public health organizations including the World Health Organization, the Food and Agriculture Organization, and the World Animal Health Organization have stated that extra-label use of antivirals in poultry could encourage the emergence of resistant strains of influenza. In crafting its new regulation, the FDA concluded that the extra-label use of adamantane and neuraminidase inhibitor drugs in poultry presented a risk to public health.

So far, no cases of avian influenza have been reported in the United States. As of March 2006, the disease has killed more than 100 people in Azerbaijan, Cambodia, China, Indonesia, Iraq, Thailand, Turkey, and Vietnam. It has been found in wild and domestic birds throughout Asia, the Middle East, and Africa, and in wild birds in Europe.

The FDA is accepting feedback about its decision through May 22, after which the agency is expected to issue its final regulations. The regulations will go into effect as drafted on June 20, 2006, unless the FDA revokes or modifies the order, or decides to extend the comment period.

UCS applauds the FDA for having the foresight to take action on this urgent public health matter.

You can add your voice to those encouraging the FDA to go forward with this regulation by submitting a comment to the agency. Address your comments to Docket No 2006N-0106 online at http://www.fda.gov/dockets/ecomments, fax it to 301-827-6870, or mail it to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.