The U.S. Food and Drug Administration (FDA) has announced plans to phase out the use of certain antibiotics in food animals as part of its effort to reserve medically important drugs for the treatment of human infection. Noting that voluntary participation “is the fastest, most efficient way to make these changes,” the agency will partner with industry to discontinue the practice of adding these drugs to animal feed and drinking water as a growth promoter. To this end, FDA has issued final guidance that urges animal pharmaceutical companies “to voluntarily revise the FDA-approved conditions on the labels of these products to remove production indications,” in addition to proposing an updated veterinary feed directive (VFD) “to facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements for the distribution and use of VFD drugs.”
“The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight,” states FDA in a December 11, 2013, press release. “Once a manufacturer voluntarily makes these changes, its medically important antimicrobial drugs can no longer be used for production purposes, and their use to treat, control, or prevent disease in animals will require veterinary oversight.”
The agency has asked animal pharmaceutical companies to notify FDA “within the next three months of their intent to voluntarily make the changes recommended in the guidance.” Participants would then have three years to implement these changes. FDA will also accept comments on the VFD proposed rule until March 12, 2013. See Federal Register, December 12, 2013.