Role of FDA and the Critical Path in the work to eliminate E. coli 0157:H7

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1 Role of FDA and the Critical Path in the work to eliminate E. coli 0157:H7 Tracey Forfa, JD Senior Policy Analyst Office of the Director Center for Veterinary Medicine, FDA

2 The Problem Escherichia coli O157:H7 is a known cause of foodborne illness. An estimated 73,000 cases of infection and 61 deaths occur in the United States each year.

3 NARMS/Retail Meats Overview FoodNet sites CT, GA, MD, MN, TN Jan 2002 OR Sep 2002 NY, CA Jan 2003 CO, NM Jan 2004 Similar sampling scheme Sites visit at least one grocery store per month Each site purchases 10 packages each of chicken breasts, pork chops, ground turkey, and ground beef All ten sites culture the rinse from each meat sample for the presence of Salmonella and Campylobacter. In addition, four sites (GA, MD, OR and TN) culture the rinse for E. coli and Enterococcus

4 NARMS/Retail Meats Overview Isolation of Salmonella, Campylobacter, E. coli and Enterococcus from retail foods Similar standardized methods used by each laboratory Isolation of bacteria is conducted at the state public health laboratories using procedures adapted from the FDA s BAM Isolates are sent to CVM/OR for identification, antimicrobial susceptibility testing and genetic studies E. coli Campylobacter Enterococcus Salmonella

5 FDA Recognizes E. coli 0157:H7 is not pathogenic in cattle and is readily carried in the intestinal tract of healthy cattle. NCBA and other groups have been working on a number of control point interventions to resolve the E. coli 0157:H7 problem.

6 FDA Recognizes The NCBA and other groups are diligently searching for on-farm interventions by funding research to identify therapeutic interventions. No single intervention will eliminate the E. coli 0157:H7 problem.

7 What FDA Can Do FDA and the Center for Veterinary Medicine are in a position to facilitate the evaluation and approval of therapeutic interventions for E. coli 0157:H7. Done through the Critical Path Initiative at FDA.

8 Critical Path FDA s Critical Path Initiative allows the Agency flexibility in mapping out the regulatory path to market for new and innovative therapeutics. The Critical Path is the scientific process through which a potential human or animal drug, biological product or medical device is transformed from discovery or proof concept into a medical product.

9 Critical Path Main components -- Critical path utilizes the newest scientific tests and tools used to predict whether a product candidate will be safe and effective. These tools can predict which product candidates do not hold promise early in the development process. Allows sponsors to direct resources to products likely to meet safety and efficacy requirements.

10 FDA s Role in Critical Path Bring national focus to current product development issues, serving as a hub for problem identification and information exchange. Serve as the catalyst, to initiate projects and collaborations to help to modernize the critical path. Encourage use of critical path tools by accepting the results of the new tools as valid proof in product review (including up-dated sciencebased standards and guidances).

11 Opportunities to Modernize Critical Path Tools Utilization of data mining and computer modeling. Development of new biomarkers. Innovative clinical trial designs. Critical Path calls for joint efforts with industry, academia, and government agencies to identify key problems and develop solutions.

12 FDA s Role in Efforts to Reduce E. coli O157:H7 Products to Address Urgent Public Health Needs is one of the key areas of focus for the Critical Path. FDA is interested as part of this process to work with sponsors to identify and bring to market interventions.

13 E. coli Coalition In 2006 NCBA and CVM joined forces. E. coli Coalition. Members of the coalition to date include (in no order of importance): FDA, NCBA, USDA, AMI, AHI.

14 E. coli Coalition Four frames have been established: Pre-harvest interventions (on the farm). Transport (from the farm to arrival at the slaughter plant). Post-harvest (from the slaughter plant to the finished/packaged product. Environmental Impact.

15 E. coli Coalition CVM is primarily active in the pre-harvest working group. CVM is working with other members to identify therapeutic interventions to reduce or eliminate E. coli O157:H7 in or on cattle presented for slaughter. Farm to fork approach with the frames identified.

16 FDA/USDA Collaboration Currently working on establishing standards for product effectiveness along with the NCBA, AHI and USDA/APHIS veterinary biologics. Standards of effectiveness utilizing critical path tools while still acceptable under our authorizing statutes.

17 Product Review CVM is very interested in working with sponsors of animal drugs to find new therapeutic interventions. We are also interested in learning about research engaged in new technologies to address this problem.

18 Product Review CVM is interested in bringing to market those technologies that have the most chance of becoming therapeutic interventions to eliminate E. coli 0157:H7 prior to slaughter. Products which have human food safety, target animal safety, environmental or resistance concerns will not qualify for the critical path expedited review.

19 Product Review Questions have also been raised whether or not potential products would be reviewed under the provisions of the Minor Use and Minor Species Act. Cattle are not a Minor Species and CVM cannot anticipate a situation where a product would qualify for designation, however, we want to leave all options open.

20 For Further Information Please visit our website Contact Dr. Steve Vaughn, Director, Office of New Animal Drug Evaluation.