FDA Announces Plans to Curtail Antibiotic Use in Farm Animals

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.