Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 78

DECLARATION of Amy A. Barcelo in Support re: 63 MOTION for Summary Judgment on Plaintiffs' First Supplemental Complaint.. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F)(Barcelo, Amy) (Additional attachment(s) added on 5/2/2012: # 6 Exhibit 6) (jfe).

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AHI Statement on FDA Guidance Documents and Draft Codified Language on Antibiotics Page 2 of 5 ◦ Industry News ◦ News & Publications AHI Statement on FDA Guidance Documents and Draft Codified Language on Antibiotics Share: Facebook | Twitter by admin • April 11, 2012 • Industry News, Press Releases and Statements AHI Statement FDA Guidance Documents and Draft Codified Language on Antibiotics April 11, 2012 The U.S. Food and Drug Administration (FDA) released three documents impacting certain uses of medically important antibiotics in animal agriculture. The animal health industry supports the process designed to protect the health of animals and ultimately public health, while preserving animal care tools for veterinarians and producers. AHI and its member companies have supported the stakeholder approach used by FDA to reach this point and we will continue to work collaboratively to implement the policy goals articulated in these documents. The veterinarian is critically important in animal care decisions and, ultimately, in protecting food safety and human health. We strongly support responsible use of antibiotic medicines and the involvement of a veterinarian whenever antibiotics are administered to food producing animals. Implementation of this policy means all medically-important antibiotics used in animal agriculture will be used only for therapeutic purposes – disease treatment, control and prevention — under the supervision of a licensed veterinarian. This policy will assure these medically important medicines are used in animal health in much the same way they are used in human health — under the supervision of a licensed professional and only to address disease challenges at various stages. While we agree with this direction and the collaborative, stakeholder process, there are details that must be addressed to make this approach practical and workable. We will continue to work with FDA through the comment process to address these details. The responsible use of antibiotics to keep food animals healthy is important to public health because healthy animals are the first link in the food safety chain. Other links in this chain include the reduction of foodborne bacteria at critical steps in processing, and good food hygiene through the safe handling and cooking of meat and poultry. Responsible use of antibiotics by farmers and veterinarians to keep food animals healthy at the beginning of the food safety chain helps the entire chain produce a safer food product. http://www.ahi.org/archives/2012/04/ahi-statement-on-fda-guidance-documents-and-draft-... 4/14/2012 AHI Statement on FDA Guidance Documents and Draft Codified Language on Antibiotics Page 3 of 5 It is important to note that this guidance and policy by FDA also fulfills the requests by a number of public health advocacy groups in a July, 2009 letter to the Senior Economic Policy Advisor at the White House. AHI represents the companies that manufacture animal health products – the pharmaceuticals, vaccines and feed additives used in modern food production, and the medicines that keep pets healthy. Share: Facebook | Twitter Speak Your Mind Name * Email * Website   Post Comment Recent News Headlines AHI Statement on FDA Guidance Documents and Draft Codified Language on Antibiotics Kansas Bioscience Authority approves $1.6 million for animal health researchers (via AgriMarketing) This Season’s Ticking Bomb (via Wall Street Journal) Rural veterinarians face changing roles (via PorkNetwork) Stay in touch with AHI! Sign up to receive the latest news and innovations in animal medicine. • Enter your email address* • http://www.ahi.org/archives/2012/04/ahi-statement-on-fda-guidance-documents-and-draft-... 4/14/2012

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