December 13, 2013
The plan announced focuses on antibiotics that are considered medically important (such as those important for treating human infection) that are approved for use in feed and water of food animals. Certain antibiotics have historically been used in feed or drinking water of cattle, poultry, hogs, and other food animals for production purposes, such as using less feed to gain weight. Some of these antibiotics are important drugs used to treat human infection, prompting concerns about the contribution of this practice in increasing the ability of bacteria and other microbes to resist the effects of a drug.
The FDA is asking animal pharmaceutical companies to notify the agency of their intent to sign on to the strategy within the next three months. These companies would then have a three-year transition process.
"Implementing this strategy is an important step forward in addressing antibiotic resistance. The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal," said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor. "Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort."
In order to help phase in veterinary oversight of those drugs covered by the guidance that are intended for medically appropriate uses in feed, the FDA has also issued a proposed rule to update the existing regulations relating to VFD drugs. The use of VFD drugs requires specific authorisation by a licensed veterinarian using a process outlined in the agency's Veterinary Feed Directive (VFD) regulations. The VFD proposed rule is intended to update the existing VFD process and facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements for the distribution and use of VFD drugs. Such updates to the VFD process will assist in the transition of OTC products to their new VFD status.
"This action promotes the judicious use of important antibiotics to protect public health while ensuring that sick and at-risk animals receive the therapy they need," said Bernadette Dunham, director of the FDA's Centre for Veterinary Medicine.
The guidance for animal pharmaceutical companies is now in final form, and the proposed VFD rule is open for public comment for 90 days that started on December 12, 2013.
