CVM Update. For the Federation of Animal Science Societies Food Safety Symposium, April 28 th 2008, Washington, D.C.

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1 CVM Update Comments by Bernadette Dunham, D.V.M., Ph.D. Director, Center for Veterinary Medicine For the Federation of Animal Science Societies Food Safety Symposium, April 28 th 2008, Washington, D.C.

2 Overview CVM Organization Update Animal Cloning Minor Use and Minor Species (MUMS) President s s Budget FY2009 for CVM Animal Drug User Fee Act (ADUFA) Food Safety FDA Amendments Act Animal Feed Safety System (AFSS) Bovine Spongiform Encephalopathy (BSE) Biotechnology Critical Path Initiative National Antimicrobial Resistance Monitoring System (NARMS) White Oak Campus

3 Leadership Change at CVM On January 7 th, 2008 after ~ 14 years as Director of CVM, Dr. Stephen Sundlof was appointed Director of the Center for Food Safety and Applied Nutrition (CFSAN). We expect even stronger ties and collaboration between CFSAN and CVM. There have been a number of other leadership changes within CVM

4 CVM Organizational Chart Office of of the Center Director Bernadette Dunham, D.V.M., Ph.D. Associate Director for Policy and Executive Programs Catherine P. P. Beck Office of of Management Director David E. E. Wardrop, Jr. Jr. Deputy Director Barbara E. E. Leach Deputy Director Gary Gary Claywell Office of of New New Animal Drug Drug Evaluation Office of of Surveillance Office of of Research Director and and Compliance Office of of Minor Uses Uses Director Steven D. D. Vaughn, D.V.M. Director M. and and Minor Species Marleen M. Wekell, Daniel G. G. McChesney, Ph.D. Ph.D. M.S., Ph.D. Animal Drug Drug Development M.S., Ph.D. Deputy Director for for Administration Deputy Director Acting Deputy Director Acting Director David Newkirk, Ph.D. Martine Hartogensis, D.V.M. Michael Thomas Margaret Oeller, D.V.M.

5 CVM Mission CVM is responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. We are developing policies and programs to make safe, effective drugs available. We are using latest science to protect public health.

6

7 CVM and Animal Cloning In 2001, when it became apparent that animal cloning may become a commercial venture to help improve the quality of herds, FDA requested livestock producers and researchers to keep food from animal clones or their offspring out of the food supply. Since then, FDA has conducted an intensive evaluation that included examining the safety of food from these animals and the risk to animal health. Based on a final risk assessment, a report written by FDA scientists and issued in January 2008, FDA has concluded that meat and milk from cow, pig, and goat clones and the offspring of any animal clones are as safe as food we eat every day.

8 CVM and Animal Cloning The agency is not requiring labeling or any other additional measures for food from cattle, swine, and goat clones, or their offspring because food derived from these sources is no different from food derived from conventionally bred animals. Should a producer express a desire for voluntary labeling (e.g., "this product is clone-free"), it will be considered on a case-by by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading. All of our decisions were based on science, using extensive amounts of data.

9 Minor Use and Minor Species Animal Health Act of 2004 We continue to make progress implementing the MUMS Act. OMUMS has granted 53 designations to date. On February 19, 2008 CVM accepted first Index application. On March 18, 2008, we published a proposed rule on small numbers for the major species. The conditional approval proposed rule is under development.

10 OMUMS Personnel Dr. Meg Oeller is the Acting MUMS Office Director. Dr. Andy Beaulieu continues his involvement. Dr. Joan Gotthardt joined in February 2008 as Director of the Indexing Program. For more MUMS information, go to fda.gov/minortoc.htm Dr. Beaulieu and Dr. Oeller Dr. Gotthardt

11 President s s 2009 Budget General Overview: The President s FY 2009 budget request for CVM totals $ million. Includes $ million in budget authority and $ million in user fees. Program Resource Changes: Ensuring a Strong FDA: +$1,043,000 This initiative will support cost of living pay increases to maintain a professional workforce at the rate of inflation.

12 Budget Food Safety Protecting America s s Food Supply: +$3,043,000 and +9 FTEs This increase is to supply funding to two areas: Prevention: Risk Assessment: +$2,286,000 and 6 FTEs Animal Feed Safety System Processing/Ingredient Standards and Definitions for Animal Feed Feed Labeling Standards Response: Strengthen Emergency Response Infrastructure: $538,000 and 2 FTEs Core Cadre of Scientists to Strengthen Feed Safety Program Risk Communications: +$219,000 and 1 FTE

13 ADUFA Update Animal Drug User Fee Act of 2003 (ADUFA) has been a success. CVM has increased staff to administer the pre-market animal drug evaluation process. We developed new guidances,, policies, and procedures. We have augmented management practices. We have shortened review times (from 295 to 180 days). The public has seen earlier access to safe and effective drugs; industry has seen predictable review times.

14 ADUFA Reauthorization Current program expires September 30, Proposed reauthorization plan: would enhance revenue; would create end-review amendment process ; contains foreign pre-approval inspection provisions; calls for public workshops; and contains plans to develop an electronic submission tool.

15 Additional Performance Goals We will discuss applicable use of pharmacokinetic/pharmacodynamic pharmacodynamic data. We will explore opportunities for early exchange of information about characteristics of a new drug. We will explore shorter review timeframes for the above. We will enhance 2-way 2 way communication to ensure high submission quality.

16 ADUFA Comments FDA sponsored a public meeting about the proposals on March 11, Proposals and process for submitting comments ware explained in February 21, 2008, Federal Register notice. More information is available at: ADUFA proposed language was submitted to the Hill on April 23, 2008 as a must pass piece of legislation.

17 Keeping Food for People and Animals Safe

18 Melamine-Contaminated Pet Food Recall of 2007 Incident brought home importance of safe feed and safe pet food. It had the broadest impact of any food recall in U.S. 19,000 calls to FDA complaint coordinators. FDA had 6.1 million Web site hits. CVM had 1.3 million Web site hits.

19 Big Impact Two suppliers in China shipped melamine contaminated products. Result: the recall hit more than 1,000 products and 60 million servings of pet food recalled. FDA response went beyond pet food to include hog, poultry, and fish feed.

20 Scientific Capabilities We must increasingly rely on our scientific capabilities to uncover problems. Experts used insight, experience to find the cause of disease and death in cats and dogs. Melamine is not known to be toxic. Melamine, combined with cyanuric acid, created crystals that resulted in renal pathology.

21 Crystal Formation Resulted in Renal Pathology Combining melamine, cyanuric acid in laboratory. Crystals form instantly. Melamine cyanurate

22 Importance of Partners FDA relied on its partners during crisis. Companies shared valuable information with us. Groups got information to consumers and other pet food companies. Press helped us get the word out. Partnerships undoubtedly saved many cats and dogs.

23 Food Protection Plan Plan covers products life cycles. The core elements are Prevention Intervention Response

24 Food for People and Animals Food Protection Plan and the Import Safety Action Plan applies to food for people and animals. Center for Veterinary Medicine has responsibility for feed safety. Initiatives underway to address intent of food protection and import safety programs.

25 Feed and Pet Food Industries Increasingly complex, international, and fast-paced industry. Variety of ingredients. Fast product distribution.

26 FDA Amendments Act of 2007 FDAAA legislation (Title X) calls for regulations to establish: ingredient standards and definitions (Sec. 1002); processing standards (Sec. 1002); labeling standards (nutritional and ingredient information) (Sec. 1002(a)(3)). Public meeting planned for May 13 th, Docket is open for FDA to accept comments from individuals, companies, and organizations both domestic and international.

27 Additional Requirements Establish an early warning surveillance and notification system (Sec. 1002(b)) to: identify adulteration and outbreaks of illness; notify veterinarians and stakeholders. Develop and place on the FDA web site a searchable database listing all recalled pet foods. Establish a reportable animal food registry (Sec. 1005). CVM is working closely with CFSAN.

28 Animal Feed Safety System Risk-based prioritization for inspection decisions for deciding what sectors require oversight Extends to ingredients Incorporates counterterrorism concerns

29 Animal Feed Safety System The strengthened AFSS will cover all aspects of feed, including ingredients. It will cover manufacturers, transporters, and distributors. AFSS Team will hold 5 th public meeting on May 14 th, Team will use the meeting to explain more on risk-based approach.

30 Food Safety = Feed Safety Food safety means feed safety: CVM is implementing pet food ingredient safety regulations; CVM is developing a comprehensive feed safety program. Partnerships are key to the success of the Food Protection and Import Safety Action Plans. Applying science and modern technologies will enable us to integrate these plans and keep pace with today s s fast moving food industry.

31 Bovine Spongiform Encephalopathy (BSE) Feed Ban Rule FDA published the final BSE rule on April 25, 2008 in the Federal Register [Vol. 73, No.81 Pg ] 22758] Substances Prohibited From Use in Animal Feed or Food Finalizes the proposed rule issued The final rule becomes effective one year from now on April 27, 2009.

32 BSE Final Rule, cont d The new rule strengthens existing safeguards by prohibiting the use of certain cattle materials in all animal feed, including pet food. The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE.

33 BSE Final Rule, cont d Cattle Material Prohibited in Animal Feed (CMPAF) is material defined as: Brains and spinal cords from cattle 30 mths.. age and older; Entire carcass of cattle not inspected and passed for human consumption unless the cattle are less than 30 mths.. of age, or the brains and spinal cords have been removed; Entire carcass of BSE-positive cattle; Tallow derived from BSE-positive positive cattle or tallow derived from any CMPAF material; and, Mechanically separated beef derived from CMPAF.

34 Cloning Genetic engineering Biotechnology

35 Genetic Engineering Must have government regulation. Consumer concerns, international trade. CVM to facilitate safe, responsible product development. Guidance Document is under development. Regulation of Genetically Engineered (GE) Animals Containing Heritable ndna Constructs. Transgenic cows resistant to mastitis

36 Biopharming Producing medicines, industrial substances CVM responsible for food safety, animal safety

37 PCR ANALYSIS OF TEST FEED Another example of the advances of biotechnology and its application to real time issues. Percent Bovine MBM* in Dairy Feed 2% 1% 0.5% 0.25% 0.1% 0.05% 0.025% Control MBM - Meat and Bone Meal PCR Polymerase Chain Reaction

38 Using Science to Protect Public Health

39 Critical Path Initiative The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, veterinary drug, biological product, food, or medical device is transformed from a discovery or "proof of concept" into a medical product. For all product areas, the basic idea is to reduce uncertainty about product performance throughout the product life cycle through scientific research. It addresses the lack of regulatory science needed to predict and evaluate product performance. (http:// /initiatives/criticalpath/)

40 CVM Critical Path Projects In 2008 CVM will be involved in: Interrogating Salmonella diversity using microarray technology. Quality by Design for predicting drug release of roller compacted formulations. Characterization of functional analysis of bronchial antimicrobial peptides. Effects of mutation in the multidrug resistance gene 1 (MDR-1) that encodes for P-glycoprotein P in dogs.

41 CVM Critical Path Projects CVM scientists using pharmacogenomics to determine drug safety. They are studying effects of mutation (4 base pair deletion) in the multidrug resistance gene 1 (MDR-1) that encodes for P-glycoprotein P in dogs. Out Membrane In = ATP binding sites Slide Courtesy of Katrina Mealey Out Membrane In P-glycoprotein MDR1 gene = Substrate binding sites P-glycoprotein Mutation

42 MDR-1 1 Gene Mutation Dogs homozygous recessive for this deletion exhibit toxicity (neurotoxicity) to the avermectin class of drugs. Most common in herding dogs. CVM requests, prior to approval, new avermectin products for dogs be tested in ivermectin-sensitive Collies. An understanding of the potential consequences of the MDR-1 1 genetic defect on drug pharmacokinetics should improve the ability of veterinary medicine to predict potential safety and effectiveness concerns in dogs carrying this mutation.

43 Reducing or Eliminating E. coli O157:H7 CVM is working with a number of animal health groups and government partners to identify therapeutic interventions. FDA/CVM is in a position to facilitate evaluation and approval of therapeutic interventions.

44 Challenges Determining how to measure safety and efficacy utilizing critical path tools while still acceptable under our authorizing statutes. Currently working on establishing standards for product effectiveness along with the NCBA, AHI and USDA/APHIS veterinary biologics.

45 National Antimicrobial Resistance Monitoring System Collaborative agreement with USDA, CDC, FDA Test for resistance in these bacteria Salmonella Campylobacter E. coli Enterococcus

46 NARMS The Three Arms FDA/USDA Animal Arm (Clinical & slaughterhealthy animals isolates) FDA/CDC Human Arm (54 participating public health departments submit isolates) FDA/CVM Retail Meat Arm CDC/FoodNet sites

47 Bacteria Tested Human - CDC Non-Typhi Salmonella E. coli 0157:H7 Enterococcus Campylobacter S. Typhi Shigella Listeria Vibrio Animal - USDA Non-Typhi Salmonella E. coli O157:H7 when available Enterococcus Campylobacter Retail meats FDA/CVM Non-Typhi Salmonella E. coli Enterococcus Campylobacter

48 NARMS Program Total number of Salmonella isolates tested, by year and by source. (*2005 and 2006 data are preliminary.) Source * 2006* Humans Chicken Breasts Ground Turkey Ground Beef Pork Chops Chickens Turkeys Cattle Swine Total

49 NARMS Data Available More details and data, including links to CDC and USDA at fda.gov/cvm/narms_pg.html

50 Antimicrobial Resistance Protecting human health through food safety Protecting animal health giving veterinarians the tools they need

51 International Antimicrobial Resistance Work Codex Antimicrobial Resistance Task Force met in Korea in October, It will develop risk analysis guidance to be used in assessing human health risks from resistance. Three working groups established: Risk assessment; Risk profiling (chaired by U.S. government); and Risk management. Next meeting - Brussels the week of May 26, 2008.

52 FDA Campus at White Oak CBER and CVM to join in 2012

53 CVM has had a change in leadership. but we have not changed our openness and willingness to listen to your thoughts and comments. Thank You!

54 CVM Mission - Protecting both Animal Health and Public Health

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