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Highlights – What’s New and Innovative?

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2011 Annual Report

What's New and Innovative

 World Veterinary Year


In 1761, the world’s first veterinary school, originally called École Nationale Vétérinaire de Lyon (National Veterinary School of Lyon), opened in Lyon, France. Three years later, École Nationale Vétérinaire d’Alfort (National Veterinary School of Alfort) opened near Paris, France. Both schools were founded by French veterinarian Claude Bourgelat and represent the start of today’s veterinary profession. 

To honor Bourgelat’s legacy and veterinarians worldwide, 2011 was declared “World Veterinary Year” by 19 countries, including the United States. World Veterinary Year, or Vet2011, has been a time to raise public awareness about the veterinary profession. It has provided an opportunity to highlight the dedication of veterinarians to the health and safety of animals and people.
The CVM Communications Staff designed a special page on the CVM Web site, “2011: World Veterinary Year,” on which we published several informative items. The site includes “Thank a Veterinarian” (for kids), a “Center for Veterinary Medicine Timeline,” and a history of veterinary medicine. A feature, “Meet Your CVM Veterinarians,” contains interesting and informative perspectives from some of the 127 veterinarians who work at CVM. Since the founding of the first veterinary school, formal veterinary education has spread to all corners of the globe. To celebrate this international diversity, the CVM Web site showcases some of the world’s veterinary schools. In addition, the Center Director sent letters to the other FDA center directors, introducing Vet2011 and noting the importance of veterinarians in maintaining human and animal health (a number of veterinarians work in FDA centers beside CVM).

CVM had representation on the U.S. Vet2011 National Organizing Committee and on the Event Accreditation Subcommittee, which reviewed and accredited events and activities proposed by member groups; these events and activities included scholarships, writing/essay contests, and traveling tabletop exhibits.

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 The Food Safety Modernization Act  

The Food Safety Modernization Act, signed into law by President Obama on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system. The law applies to pet food and animal feed in addition to human food, and therefore will radically change how CVM regulates pet food and animal feed.

The Food Safety Modernization Act enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention-based and risk-based food safety standards. It also enables the agency to better respond to and contain problems when they do occur. The law further gives FDA important new tools to hold imported foods to the same standards as domestic foods, and directs FDA to build an integrated national food safety system in partnership with state and local authorities.

For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes:

Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan.

Authority to prevent intentional contamination: FDA must issue regulations to protect against the intentional adulteration of food. As part of this, FDA must establish science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.

The Food Safety Modernization Act provides FDA with important new tools for inspection and compliance, including:

Mandated inspection frequency: The Food Safety Modernization Act establishes a mandated inspection frequency for food facilities, based on risk, and requires the frequency of inspection to increase immediately.

Records access: FDA will have access to records, including industry food safety plans and the records that firms will be required to keep documenting implementation of their plans.

Testing by accredited laboratories: FDA is directed to establish a program for laboratory accreditation.

The Food Safety Modernization Act provides FDA with tools to respond effectively when problems emerge, includingmandatory recall, expanded administrative detention, suspension of registration, enhanced product tracing abilities, and additional recordkeeping for high risk foods.

With respect to imported food, the Food Safety Modernization Act gives FDA unprecedented authority including authority for importer accountability, third-party certification, certification for high risk foods, voluntary qualified importer program, and authority to deny entry.

Finally, the Food Safety Modernization Act has provisions for enhanced partnerships, including building state and local capabilities, building foreign capabilities, and relying on inspections by other agencies.

CVM has taken leadership within and outside the agency in the implementation of the Food Safety Modernization Act and the FDA food safety program generally. For example, the Deputy Center Director is serving as Vice-Chair of the FDA Federal/State Integration Team, directing the building of the strategic and operational partnerships with Federal, state, and local food safety agencies necessary to carry out an effective and efficient food safety program. The Director of the Office of Surveillance and Compliance served as the co-chair of the Preventive Controls Team. A number of other CVM staff members are serving as leaders and members of Food Safety Modernization Act teams that include imports, preventive controls, inspection and compliance, reports, Federal/state integration, and user fees. The teams are developing a wide array of deliverables, including plans, new programs, guidances, and regulations.

We provide more detail on the implications of the Food Safety Modernization Act for the regulation of pet food and animal feed, and related accomplishments from FY 2011 in the section of this report titled “Ensuring Food Safety.”

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FDA Foods and Veterinary Medicine Strategic Plan: 2012-2016

 

Carrying out FDA’s food safety, nutrition, and animal health activities becomes more challenging every year because of the impact of globalization, advances in science and technology, foodborne illnesses, and other factors. Congress recognized the unique challenges faced by FDA in the area of food safety in the 21st century through passage of the Food Safety Modernization Act of 2011. With such new mandates and authorities come greater responsibilities, including the obligation to make optimal use of resources to protect and promote public health.
 

Published in September 2011, the Foods and Veterinary Medicine Program Strategic Plan: 2012–2016 charts a direction for the future with the Food Safety Modernization Act in mind. Program personnel have assessed the program’s current capabilities and have developed a new mission and vision for the unified Foods and Veterinary Medicine Program. Program personnel have identified key goals, objectives, and initiatives to advance food safety, nutrition, and animal health in the years to come.


The plan has a cross-cutting goal to improve effectiveness and efficiency across all levels of the Foods and Veterinary Medicine Program. It also includes program goals that apply to the responsibilities of both the Center for Food Safety and Applied Nutrition, and CVM:

  • Foods and Veterinary Medicine Program Goal 1: Establish science-based preventive control standards across the farm-to-table continuum;

  • Foods and Veterinary Medicine Program Goal 3: Strengthen scientific leadership, capacity, and partnership to support public health and animal health decision making; and

  • Foods and Veterinary Medicine Program Goal 6: Improve detection of and response to foodborne outbreaks and contamination incidents.

(NOTE: FVM goals 4 and 5 are not applicable to CVM.)

The plan also has a program goal to advance animal drug safety and effectiveness (Foods and Veterinary Medicine Program Goal 7). There are three objectives within that goal:

 “Increase access to safe and effective animal drugs and reduce risk of harm from unsafe use of marketed animal drugs.” Key initiatives related to this objective include: optimizing new animal drug evaluation functions and ensuring that user fee timeframes, goals, and commitments are met; enhancing the development of drugs for minor use and minor species; and enhancing the capabilities of the Adverse Drug Event pharmacovigilance surveillance system.

“Reduce availability of substandard and illegally marketed animal drugs.” Key initiatives include: developing risk-based frameworks that assure quality and safety for products that are currently being marketed without FDA approval; and developing and implementing an enforcement strategy that addresses the illegal compounding of new animal drugs and removes unsafe, ineffective, or copycat animal drugs from the market.

“Foster the judicious use of medically important antibiotics in food animals to minimize the development of antimicrobial resistance.” Key initiatives include: issuing final guidance on the judicious use of medically important antimicrobial drugs in food-producing animals and simplifying the process for voluntarily phasing out non-judicious uses; conducting outreach and education with external stakeholders to implement the judicious use guidance recommendations; evaluating public health impact and developing strategies to address the extralabel use of drugs in food-producing animals; and evaluating the use of antimicrobials in ethanol production.

CVM was heavily involved in development of the Foods and Veterinary Medicine Program Strategic Plan. The CVM Executive Board reviewed and had extensive input into the plan. Strategic planning experts from the CVM Office of Management helped guide us through the process. In addition, staff members from throughout the Center were involved in 2-day focus group workshops. The overall objective of the workshops was to discuss what the Foods organization needs to look like in order to deliver on our mandate, strategy, and objectives.

The complete text of the program goal to advance animal drug safety and effectiveness is in Appendix G.

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Improving Efficiency and Effectiveness Through Electronic Submissions: Innovation in the Pre-Approval and Post-Approval Spheres

Pre-Approval Submissions Through eSubmitter

In March 2011, CVM released an electronic submission tool, eSubmitter, for use in pre-market submissions—Investigational New Animal Drug files (INADs), New Animal Drug Applications (NADAs), and other filings. Electronic submission eliminates the need for paper, reduces printing and mailing costs for the veterinary drug industry, and allows CVM scientists to review the submissions electronically. eSubmitter provides a structured online system allowing for a more efficient, more effective, and less expensive drug approval process than with paper submissions. Introduction of eSubmitter followed a CVM workshop held in October 2010 to solicit feedback from the regulated industry on the electronic submission tool.
 
The development and release of eSubmitter meets one of the goals of the Animal Drug User Fee Amendments of 2008. The Animal Drug User Fee Act required the creation of a tool for INAD and NADA electronic submissions; however, CVM expanded the development to include all pre-market submission types. Along with the INAD and NADA submissions, the tool will permit the creation and submission of Generic Investigational New Animal Drug files, Abbreviated New Animal Drug Applications (ANADAs), Veterinary Master Files, and General Correspondence files.
 
For additional information or to download and install eSubmitter, please see the FDA’s Web site at the following URL: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm226816.htm. For questions about CVM’s eSubmitter program, please email the CVM eSubmitter team at cvmesubmitter@fda.hhs.gov.
 

Electronic Submission of Adverse Drugs Experience (ADE) Reports

Veterinary drug manufacturers are required to report ADEs and product and manufacturing defects to CVM on a regular basis. This continuous monitoring of approved NADAs and ANADAs is the primary means by which CVM obtains information regarding potential problems with the safety and effectiveness of marketed new animal drugs as well as potential product/manufacturing problems. 

Prior to FY 2011, all ADEs were reported to CVM on paper. This required each report to be manually entered and then individually reviewed and medically coded by a CVM reviewer. The number of ADE reports received annually (now more than 54,000 per year) has for several years exceeded the review capacity of our reviewers, resulting in a paper backlog and a significant time lapse between submission and review. While the utilization of contracted data entry staff greatly assisted in reducing the backlog of paper ADE reports during the previous 2 years, closing the gap in the long term ultimately depends on the ability to receive these reports electronically.

Following several years of development work, we achieved full implementation of electronic reporting in 2011 when the first major drug sponsor began submitting ADE reports electronically. Firms in the animal health industry now have the option of satisfying their ADE reporting requirements electronically either by submitting reports directly through the Electronic Submissions Gateway, or by using the Safety Reporting Portal. The Electronic Submissions Gateway is designed for those drug sponsors who have information technology systems for processing ADE reports electronically, and allows for the submission of batched reports. The Safety Reporting Portal is designed for drug sponsors without existing information technology infrastructures for processing ADE reports, and provides a means for them to submit individual ADE reports electronically to CVM.

Electronic reporting reduces the burden on the drug sponsor of having to create and mail voluminous paper submissions. Electronic reporting also improves efficiency for CVM because all information from the report is immediately available for review and/or trending analysis without any downtime for data entry.

Electronic submissions have been well received by the industry. The percentage of electronic reports CVM receives electronically has increased each month. The average time to review priority reports has decreased substantially, saving valuable time and resources. Additional sponsors have indicated interest in reporting through the Electronic Submissions Gateway,are actively testing and validating their information technology systems, and hope to begin submitting electronic reports within the next fiscal year.

In September 2011, for the first time, the number of ADE reports received electronically during the month exceeded the number of ADE reports the Center received on paper.
 
 
Spurred by the 2007 crisis during which many pets died due to melamine-contaminated pet food, CVM has taken leadership in establishing two complementary programs that greatly facilitate response to similar incidents: the Pet Event Tracking Network (PETNet) and Veterinary Laboratory Response Network (Vet-LRN). These innovative programs anticipated the Food Safety Modernization Act’s goal of responding effectively when problems emerge, and meet the Foods and Veterinary Medicine Strategic Plan goal of strengthening scientific leadership and partnership to support public health and animal health decision making.
 

PETNet

The Partnership for Food Protection and CVM launched the Pet Event Tracking Network (PETNet) in August 2011.

FDA established the Partnership for Food Protection in 2008 to bring together Federal, state, local, territorial, and tribal representatives with expertise in food, feed, epidemiology, laboratory, animal health, environment and public health to develop an Integrated Food Safety System (IFSS). The importance of the work is underscored by the passage of the Food Safety Modernization Act of 2011, which codifies an expectation for an IFSS.

PETNet is a voluntary, secure, Web-based information exchange, surveillance, and alert system that allows FDA and Federal and state agencies to share timely information about pet food-related incidents, such as illness associated with the consumption of pet food or pet food product defects.

The system is accessible only to PETNet members, who are Federal, state, and territorial government officials responsible for the regulation of pet food products and the investigation of disease outbreaks in companion animals. PETNet members can use the data entered into PETNet to track the emergence of illness association with pet food products and pet food product defects, and to evaluate the need for action within individual jurisdictions. PETNet will increase efficiency in communication between Federal and state agencies for identifying and potentially responding to concerns associated with pet food.

PETNet is currently made up of more than 200 representatives from four Federal agencies (the U.S. Department of Agriculture, the U.S. Centers for Disease Control and Prevention, Department of Homeland Security, and FDA), all 50 states, Puerto Rico, and the District of Columbia.
 

Veterinary Laboratory Response Network (Vet-LRN)

During the melamine crisis in 2007, CVM identified a major gap in the ability of FDA to obtain or share information with state and academic veterinary diagnostic laboratories responding to chemical and microbial feed or drug contamination events. In 2010, CVM obtained funding to create what has become Vet-LRN to partner with veterinary diagnostic laboratories nationwide. The goal is to document, investigate, and diagnose animal feed, pet food, and animal drug-related illnesses.

During Vet-LRN’s first year, a program director was recruited, and collaborations with the existing Food Emergency Response Network[1] were established. A developmental meeting in March 2011 provided opportunity for exchange of information between CVM and laboratory directors. Two priority projects were developed: one that focuses on chemical adulterants, and another that focuses on microbial contamination of animal feed. These projects were conducted during FY 2011, during which time the infrastructure of the Vet-LRN program was developed. The activities and accomplishments of Vet-LRN during FY 2011 include the following projects.

Microbiological contamination. In collaboration with the Food Emergency Response Network, Vet-LRN is working with six separate food-testing laboratories and focusing on four different pathogens in animal feed that compromise feed safety -- Salmonella, Listeria, Escherichia coli O157:H7 and generic E.coli. The information gained from this testing will help CVM prioritize the Center’s surveillance efforts, and will increase the capabilities of field laboratories to work with unusual types of substances, such as dried or semi-soft items, encountered in animal feed.

Chemical contamination. In collaboration with the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service, Vet-LRN is working with three chemistry laboratories on detection of melamine and cyanuric acid in pig tissue samples. This effort increases the agencies’ preparedness in case of melamine feed contamination by developing optimized methods for multiple edible tissue types such as ham, pork loin, and kidney.

Proficiency testing. In collaboration with FDA’s Center for Food Science and Applied Nutrition, CVM is working with the Institute for Food Safety and Health, Illinois Institute of Technology Moffett Campus, to provide chemical and bacterial proficiency testing for Vet-LRN labs. Such activities will document the readiness and accuracy of the laboratories in the network to conduct these tests.

Salmonella presence. Vet-LRN entered into its first 11 cooperative agreements with state and university diagnostic laboratories for evaluation of Salmonella prevalence in dog and cat diagnostic samples. This initiative results from reports of human Salmonella outbreaks attributed to pet treats and pet foods. The studies will be directed toward characterizing the occurrence of salmonellosis in dogs and cats; the data will help CVM prioritize our investigations of foodborne diseases that adversely affect both animal and human health.

Identification of contaminants. Vet-LRN awarded a contract to the University of California at Davis Diagnostic Laboratory to determine which food safety contaminants (bacterial and chemical) veterinary diagnostic laboratories have encountered since 2006.

Diagnostic samples. Vet-LRN awarded a contract to the Iowa State Veterinary Diagnostic Laboratory to provide diagnostic samples and coordinate activities between the American Association of Veterinary Diagnostic Laboratories and the Vet-LRN program office, the Institute for Food Safety and Health, Illinois Institute of Technology Moffett Campus, and other Vet-LRN diagnostic laboratories.

Since its inception, Vet-LRN has investigated a number of cases of suspected feed- associated illnesses, and has collaborated with CVM’s Complaint Emergency Recall Team to evaluate which potential cases should receive further testing. Vet-LRN reviewed more than 40 adverse event cases during the fiscal year, and analyzed a number of specimen sample collections resulting from the adverse event reports.

As a result of recruiting and networking efforts, Vet-LRN had 22 member veterinary diagnostic laboratories at the end of the year, with 6 additional memberships pending.
 

 Unapproved New Animal Drugs Initiative


In December 2010, FDA/CVM announced an initiative to address the marketing of unapproved animal drugs. The action is in response to the prevalence of animal drug products marketed in the United States without approval or other legal marketing status. The agency is concerned that the safety and effectiveness of these actively marketed products have not been demonstrated. FDA recognizes that the continued availability of a number of these products is important to meet the health needs of animals.

The agency’s position on unapproved new animal drugs has evolved over the years in consideration of new legislation that makes it easier for firms to obtain legal marketing status, the need for consistent treatment of the regulated industry, and the assurances of safety and effectiveness provided by the new animal drug review process.

To start off the initiative, FDA published a notice in the Federal Register and CVM launched a new Web page. The Federal Register notice requested comments from the public on ways to increase the availability of legally marketed animal drugs.

FDA expects drug companies to legally market animal drugs, in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act. However, FDA is open to new approaches using the agency’s existing authority, and new approachesthat may require additional authority,to make more drugs legally available to veterinarians, animal producers, and pet owners. Such strategies may include alternative pathways to achieving legal marketing status that ensure that animal drug products meet safety and effectiveness standards. Examples offered in the Federal Register notice include monographs and use of publicly available information such as published literature. FDA may exercise enforcement discretion to maintain access to essential unapproved animal drugs while drug companies work to get these drugs on the market legally. However, the agency’s goal is to limit, to the extent possible, its use of enforcement discretion for unapproved new animal drugs.

CVM received approximately 300 comments in response to the Federal Register notice from a wide range of stakeholders including veterinarians, pet owners, pharmacists, industry representatives, and professional organizations. CVM is evaluating the comments as it considers next steps.

The Unapproved Animal Drugs Web Page[1] explains what illegally marketed unapproved animal drugs are, and why FDA is concerned about these drugs. The Web page also explains the difference between an animal drug and an animal device, explains how generic animal drugs are different from unapproved drugs, and provides information for veterinarians to help them determine whether the drugs they are using are approved.

A Center-wide working group is guiding the Center’s unapproved drugs initiative. Within the context of the Center-wide effort, the Office of New Animal Drug Evaluation has the goal of developing an approach to evaluating scientific literature and determining the weight of scientific evidence that could be used to determine safety and/or effectiveness of some marketed unapproved drugs.

Using a weight-of-evidence approach for evaluation of potassium bromide for treating canine seizures due to idiopathic epilepsy, the Office of New Animal Drug Evaluation found a large amount of published literature that could be used to support a literature-based approach for the evaluation of the safety of potassium bromide in dogs. ONADE’s conclusions from this new approach were published in the Journal of the American Veterinary Medical Association. Our experiences with the review of potassium bromide have also resulted in key recommendations for future reviews, related to the process for the weight-of-evidence approach, training of reviewers, and other topics.

The Office of New Animal Drug Evaluation also continues to work with drug sponsors who are pursuing approval of currently marketed unapproved drugs. With every drug approval, FDA succeeds in its mission of protecting animal health by providing the end-users with safe, effective, quality-manufactured, and properly labeled products. Four approvals since the start of the unapproved drugs initiative are particularly significant in that they provided an approved product where previously veterinarians only had access to unapproved products. Two of these approved products, domperidone and deslorelin acetate, were highlighted in the 2010 CVM Annual Report.

The other two products, approved during FY 2011, are phenylpropanolamine and pergolide. The approved phenylpropanolamine product, marketed under the trade name PROIN, is indicated for the control of urinary incontinence due to urethral sphincter hypotonus in dogs. The approved pergolide product, marketed under the trade name PRASCEND, is indicated for the control of clinical signs associated with pituitary pars intermedia dysfunction (equine Cushing’s disease) in horses.
 

CVM’s “Best Practice” Strategic Human Capital Plan 2012-2016


Key to the successful accomplishment of CVM’s operational goals and objectives is the Center’s strategy to effectively recruit, retain, reward, and engage its workforce. Without a carefully thought out tactical approach to the Center’s human capital management, CVM would not be adequately prepared to respond to its scientific and regulatory demands both now and in the future. Given this, CVM’s Office of Management in FY 2011 developed the Center’s first Strategic Human Capital Plan which guides the creation and implementation of CVM’s human capital programs over a 5-year time frame (FYs 2012-2016). The plan is an innovative approach that has received “best practice” recognition from FDA.

Specifically, the Center’s Strategic Human Capital Plan captures distinct activities that comprise an integrated talent management system. This system addresses the entire employee lifecycle and will allow CVM to continue to build an adaptable workforce. The measurable actions outlined in the plan are geared toward attaining four broader human capital goals:
  • Goal 1 – Attract and select talented individuals who have a passion for protecting human and animal health
  • Goal 2 – Cultivate a stimulating and rewarding work environment
  • Goal 3 – Facilitate continuous learning and knowledge management
  • Goal 4 – Champion employee wellness and work/life balance
In addition, the goals were appropriately aligned with the Center’s operational priorities and current working environment as well as with the human capital direction of both the Department of Health and Human Services (HHS) and FDA. This “crosswalk” allowed for a comprehensive plan.

In concert with Center leadership, the Office of Management designed and has begun implementation of the Strategic Human Capital Plan. As part of this strategy, distinct action plans have been developed for the majority of the overarching goals outlined in the plan. The action plans are unambiguous, providing specific guidance on: (1) the action to be taken, (2) the result or outcome expected from the action, (3) key milestones and timelines, and (4) the responsible (accountable) party(ies). On a regular basis, each action will be evaluated to ensure that the responsible party(ies) is meeting desired timelines and that the action is achieving the desired results. Overall, the Strategic Human Capital Plan is designed not only to provide guidance and direction for the Center Executive Board but also to set expectations for all members of the CVM workforce. The Plan clearly demonstrates CVM’s long-term commitment to valuing its workforce as its most significant asset.
 
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