FDA Takes Significant Steps to Address Antimicrobial Resistance; Industry Responses

December 17, 2013 — 

The U.S. Food and Drug Administration is implementing a plan, Guidance for Industry 213, to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.

In the final guidance, the FDA lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications. The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight. 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 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.

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 also has issued a proposed rule to update the existing regulations relating to Veterinary Feed Directive (VFD) drugs. The use of VFD drugs requires specific authorization by a licensed veterinarian using a process outlined in the agency’s 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.

The guidance for animal pharmaceutical companies (GFI 213) is now in final form, and the proposed VFD rule is open for public comment for 90 days starting on Dec. 12, 2013. To electronically submit comments on the proposed VFD rule, go to http://www.regulations.gov and insert docket FDA-2010-N-0155. Send written comments to the Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.

Zoetis issued a statement supporting the FDA’s efforts to voluntarily phase-out growth promotion indications for medically important antibiotics in food producing animals. According to the statement, Zoetis plans to implement Guidances #209 and #213 and has already taken action.

The Animal Health Institute (AHI), which represents animal drug manufacturers, also responded to the announcement. In a published statement, AHI indicated that their member companies have supported this policy since it was announced in 2012 and will continue to work with FDA on its implementation. The statement went on to say that the policy fulfills the request by a number of public health advocacy groups in a July, 2009 letter to the White House.

The American Veterinary Medical Association also released a press statement applauding the actions by the FDA. The association offered to assist USDA and FDA in educating veterinarians, producers and feed suppliers as they transition to comply with the new guidance over the next three years.