FDA Update On Animal Pharmaceutical Industry Response To Guidance #213

On December 11, 2013, the FDA announced the implementation of its plan to help phase out the use of medically important antimicrobials in food animals for food production purposes. As part of this plan, FDA asked the animal pharmaceutical industry to seek withdrawal of animal drug approvals relating to any production uses and transfer the remaining therapeutic uses of these drugs under the oversight of a veterinarian. FDA asked affected sponsors to notify the agency in writing within three months, or by March 12, 2014, of their intent to engage with FDA as defined in Guidance for Industry (GFI) #213. FDA is encouraged by the response thus far and will continue to monitor ongoing participation and provide public updates on a periodic basis. Following is a summary of the responses FDA received from the affected sponsors.

• The number of affected sponsors is 26.
• 25 sponsors confirmed in writing their intent to engage with FDA as defined in Guidance #213 and have given FDA consent to list their names in this update.
• These 25 sponsors hold 99.6 percent of the applications affected by Guidance #213.
• These applications represent 99.95 percent of the total sales of products affected by Guidance #213, based on 2011 data. (Because the majority of sponsors indicated their intent to engage in this process, publicly releasing the total volume of sales of all products affected by GFI #213 would indirectly reveal the sales data of sponsors that did not notify FDA of their intent to engage or did not wish to make their intent public. FDA is legally prohibited from sharing confidential business information, including the sales data of individual sponsors.)

FDA will update its listing of Applications Affected by GFI #213 to indicate what actions have been finalized regarding individual drug applications (e.g., removal of production indications, change to veterinary oversight). Some sponsors may opt to voluntarily withdraw their approved applications for certain products. After an application is voluntarily withdrawn, those product(s) can no longer be marketed or sold in the United States.

As of March 26, the following sponsors have agreed in writing that they intend to engage in the judicious use strategy by seeking withdrawal of approvals relating to any production uses and changing the marketing status of their products from over-the-counter to use by Veterinary Feed Directive or prescription, and have consented to allow FDA to publicly acknowledge their participation:

• ADM Alliance Nutrition, Inc.
• Agri Laboratories, Ltd.
• Bayer Healthcare LLC, Animal Health Division
• Boehringer Ingelheim Vetmedica, Inc.
• Contemporary Products, Inc.
• Cross Vetpharm Group Ltd.
• Elanco Animal Health, A Division of Eli Lilly & Co.
• First Priority, Inc.
• G.C. Hanford Manufacturing Co.
• Huvepharma AD
• Intervet, Inc.
• Med-Pharmex, Inc.
• Merial Ltd.
• Micro Beef Technologies LTD
• Novartis Animal Health US, Inc.
• Pennfield Oil Co.
• Phibro Animal Health Corp.
• Quo Vademus, LLC
• Ridley USA Inc.
• Sparhawk Laboratories, Inc.
• Strategic Veterinary Pharmaceuticals, Inc.
• Veterinary Services, Inc.
• Vetoquinol N.-A., Inc.
• Virbac AH, Inc.
• Zoetis Inc.

On December 11, 2013, FDA identified 27 sponsors holding a total of 287 affected applications, but the agency has revised these numbers based on the following changes:

• After the publication of GFI #213, Provimi North America, Inc. requested voluntary withdrawal of all three of its affected applications. Although this request has not been finalized with publication in the Federal Register, Provimi North America, Inc. has given FDA consent to publicly acknowledge this request. Once these changes are finalized, this company will no longer have any applications affected by GFI #213. These applications no longer appear in the listing of Applications Affected by GFI #213.
• One combination application (140-955) for Coban/Flavomycin was inadvertently included in the list of affected applications. Since neither of the ingredients in this combination (monensin and bambermycin) are important in human medicine, this application has been removed from the current list of affected applications.

The current listing of Applications Affected by GFI #213 reflects these changes. There are currently 26 sponsors holding a total of 283 affected applications. These include new animal drug applications (“pioneer”), abbreviated new animal drug applications (“generic”), and combination new animal drug applications (which can be either pioneer or generic).