Animal Drugs and Feeds Selected FY 2006 Accomplishments
Increase Premarket Drug Availability
The following FY 2006 accomplishments support FDA’s strategic goals to (1) increase access to innovative products and technologies to improve health; and (2) improve product quality, safety and availability through better manufacturing and production oversight. CVM demonstrates the following results that ensure new animal drug products are safe and effective for both animals and the public with respect to both companion animals and animals intended for food consumption. In addition, four results demonstrate how CVM ensures faster review time so that more drugs are readily available to the public:
FDA met or exceeded all the ADUFA performance goals for FY 2005 on the applications that were submitted and acted on in FY 2005.
As of September 30, 2006, FDA has met or exceeded all of the performance goals defined under ADUFA for FY 2006 for applications that were submitted and acted on. Additional applications received in FY 2006 remain pending review and action, but are still within ADUFA timeframes.
FDA met its goal of having 50 percent of additional FDA review staff recruited and on-board by the first quarter of FY 2006.
FDA published three policy and procedure documents that were adopted in FY 2006 to improve the efficiency, quality, and predictability of the new animal drug review process.
FDA approved the following noteworthy animal medicines in FY 2006.
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DRUG |
PURPOSE |
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EQUIOXX (Firocoxib) |
Oral Paste for Horses - an NSAID administered for up to 14 days for the control of pain and inflammation associated with osteoarthritis |
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ZILMAX (zilpaterol hydrochloride) |
For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle feed in confinement for slaughter during the last 20-40 days on feed. |
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CYDECTIN (moxidectin) |
Oral Drench for Sheep - for the treatment and control of various internal parasites in sheep. This was a minor species approval |
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AQUAFLOR (florfenicol) |
Type A medicated article – for the control of mortality due to enteric septicemia of catfish. |
In the area of generic animal drugs, CVM met with the generic animal drug sponsors Animal Drug Alliance to explore the possibility of establishing user fees to support the review of abbreviated new animal drug applications.
In the area of antimicrobial resistance, CVM conducted a Veterinary Medicine Advisory Committee meeting on the microbial food safety of a one of its kind drug for bovine respiratory disease in cattle. The meeting was part of the overall pre-approval risk management strategy to lessen or control antimicrobial resistance to this new drug.
CVM demonstrates results in two areas of the Office of Minor Use and Minor Species Animal Drug Development (OMUMS):
By the end of FY 2006, OMUMS initiated the review process on more than 50 requests for designation of drugs intended for minor use or minor species and granted 38 of those requests.
On August 22, 2006, CVM published the proposed indexing regulations which establish formal procedures to implement a major portion of the MUMS act; this is the second of three sets of implementing regulations required to be published by the MUMS legislation.
Regulate Animal Biotechnology Products
In FY 2006 CVM supported FDA’s strategic goal to increase access to innovative products and technologies to improve health by understanding scientific and risk issues in order to develop an appropriate approach to regulating animal biotechnology. With the base resources CVM is able to demonstrate results in five areas:
CVM continued development of a transgenic animal policy by participating in on-going deliberations with USDA Biotechnology Regulatory Services and with other parts of FDA to evaluate the role of genetically engineered animals in the Coordinated Framework for the Regulation of Biotechnology.
Approximately a dozen one-on-one sessions were conducted with prospective and current sponsors of Investigational New Animal Drug Applications and Import Tolerances for animal biotechnology products relating to requirements necessary to receive marketing approval.
CVM completed an update of the draft Risk Assessment on Animal Clones and their Progeny, Proposed Risk Management Plan, and a draft GFI on the use of cloning technology in animal breeding and release of clones and their progeny into the food supply.
CVM completed a peer review of the draft risk assessment, a communications package and a detailed “rollout” plan for the public release of the entire package.
CVM began distributing the draft risk assessment, proposed risk management plan, and draft GFI to other USG agencies for comment and information and conducted detailed briefing sessions on the cloning package to develop a seamless release strategy.
Safeguard against Bovine Spongiform Encephalopathy (BSE)
In FY 2006 CVM supported FDA’s strategic goal to enhance patient and consumer protection and empower them with better information about regulated products by safeguarding human and animal health in the U.S. from BSE. With the base resources CVM is able to demonstrate results in nine areas:
On October 6, 2005, FDA published a Proposed Rule that would ban the use of certain high risk cattle materials in all animal feeds and pet food receiving more than 800 comments including comments relating to the agency’s analysis of the potential economic and environmental impacts of the proposed measures; the measures proposed by this rule add an additional firewall to the protections already provided by the current BSE feed rule.
FDA worked with Federal and State agencies and industry to discuss alternative disposal of bovine-origin material that will be diverted from animal feed use by the new rule.
CVM completed the development of a real-time Polymerase Chain Reaction (PCR) based method capable of detecting cattle, swine, sheep, goats, horses, or deer material along with poultry, goose, and turkey for use in analyzing samples of animal feeds and feed ingredients in support of the animal protein prohibition.
CVM completed the evaluation of a fourth commercially available diagnostic test kit marketed for the detection of ruminant proteins in animal feed.
CVM initiated training and installation of the Harvard BSE Risk Assessment simulations that enables testing of proposed risk management proposals in terms of the effects on the spread, and rate of elimination of BSE.
FDA and CVM conducted training sessions for Federal and State investigators on the BSE compliance program in order to enhance uniformity and quality of domestic inspections, to provide clear detailed instructions for inspections and enforcement follow-up and to provide updates on the science of BSE and animal protein detection methods.
CVM worked with USDA to show that U.S. BSE controls measures meet international BSE-related standards for trade of cattle and bovine origin materials.
CVM provided personnel and expertise on BSE and animal feed issues to the U.S. Department of Agriculture in support of its efforts to reopen foreign markets for U.S. beef.
CVM worked with ORA to evaluate applications from over 30 state feed regulatory agencies for BSE cooperative agreement funding to strengthen the BSE component of their feed programs.
Safeguard against Bovine Spongiform Encephalopathy (BSE) – Field Activities
BSE Cooperative Agreements: Currently, there are 8 BSE Cooperative Agreements in place with state agencies in support of the FDA Ruminant Feed Ban. Specifically, ORA provides the necessary support to: train state personnel dedicated to conduct BSE testing and inspections, provide supplies and laboratory equipment for analysis of feed samples using FDA validated methods, and increase the number of inspections of renderers, protein blenders and feed mills conducted by state personnel.
BSE Finding in Cow in Alabama: FDA and USDA conducted a joint investigation in response to a positive BSE finding in a cow in Alabama in March 2006. The investigation determined that the animal was born prior to FDA’s 1997 feed ban. Therefore, FDA conducted investigations at local feed mills and found that all of those handling prohibited materials were in compliance with the FDA’s feed ban. This compliance demonstrates that FDA’s BSE feed ban is providing a reliable firewall against further transmission of BSE.
Ensure Food Safety
In FY 2006 CVM supported FDA’s strategic goals to enhance patient and consumer protection and empower them with better information about regulated products and improve product quality, safety, and availability through better manufacturing and production oversight by keeping animals intended for food consumption safe for human consumption.
In the area of pandemic influenza, CVM is able to demonstrate results in two areas:
CVM drafted guidance banning the use of high risk avian influenza materials from being used in animal feed.
CVM established a CVM Avian Pandemic Influenza Work Group that develops policies and approaches to feed and animal drug hazards that are consistent with other FDA components and other federal agency actions.
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FDA Prohibits Use of Human Anti-Viral Drugs in Poultry The FDA has issued an order that prohibits the extralabel use in poultry of two classes of approved human anti-influenza drugs to help preserve the effectiveness of these drugs for treating or preventing influenza infections in humans. The order prohibits the extralabel use of anti-influenza adamantine and neuraminidase inhibitor drugs in chickens, turkeys, and ducks. Extralabel use refers to the use of a human or animal drug that is beyond the scope of the approved labeling. The extralabel use of these human antiviral drugs in poultry could lead to the emergence of resistant strains of type A influenza. Avian influenza, including the H5N1 subtype, is identified in other countries as a type A influenza. Extralabel use of human antivirals in poultry could become a concern if highly pathogenic avian influenza emerged in the United States. The Order of Prohibition was issued as a final rule and took effect June 20, 2006. |
With the use of the Animal Feed Safety System, CVM is able to demonstrate results in two areas:
CVM prepared and made available for public review draft documents that provide (1) the health consequence scoring for chemical, biological, and physical contaminants in animal feed, and (2) those contaminants in animal feed FDA will be considering at this time as part of the risk-ranking model.
CVM drafted a standard operating procedure describing the internal procedure for ensuring the development of appropriate analytical feed methods as a component of the regulatory limit-establishing process for animal feed contaminants.
In order to provide safe use of antimicrobials in food animals while ensuring that significant human antimicrobial therapies are not compromised or lost, CVM demonstrates results in five areas related to antimicrobial resistance:
CVM completed development of standardized in vitro susceptibility testing methods for different types of bacteria.
CVM completed and published studies comparing different molecular fingerprinting techniques from animals and retail meat and poultry.
CVM funded a cooperative research agreement to the University of Maryland to study antibiotic resistance bacteria in food animals, abattoir workers, and human referent groups.
The review of the penicillin approvals was completed and CVM is considering what further action may be needed.
FDA developed a regulatory strategy for managing the potential risks associated with the use of antimicrobial drugs in food-producing animals and held several public meetings.
In the area of the National Antimicrobial Resistance Monitoring System (NARMS), CVM demonstrates results in four areas:
CVM released the third annual NARMS retail meat report on September 21, 2006 providing 2004 data on the prevalence of antimicrobial resistant foodborne pathogens and commensal bacterial among retail meat and poultry samples, comprising results from nearly 4800 samples.
CVM improved NARMS testing methods and sampling strategies which in turn are being incorporated into public health surveillance systems in Canada, Europe, and Central and South America, and are now being used by WHO laboratories worldwide.
CVM worked with USDA and CDC to develop complementary databases, as well as address harmonization of testing methods and data reporting in order to enhanced the transparency of the program to stakeholders
CVM strengthened NARMS by establishing a DNA fingerprinting database of Salmonella and Campylobacter isolated from NARMS retail meats.
In the area of tissue residue CVM demonstrates results in four areas:
CVM successfully converted the Residue Violation Information System (RVIS), which contains information on all tissue residue violations and violators identified since 1988, to a web-based application that uses an Oracle Relational Database.
CVM finalized a document regarding Tissue Residue and Milk Program Coordination and obtained Field Committee agreement to incorporate these principles into the compliance program.
CVM scientists developed a method to detect residues of nitrofurans, a class of banned animal drugs, in milk.
CVM provided guidance and support to both CFSAN and the States for the cooperative, Grade “A” milk program in order to ensure that both the milk industry and the States have confidence in the drug residue testing mandated by the Pasteurized Milk Ordinance.
In the area of aquaculture CVM demonstrates results in four areas:
CVM researchers made significant progress in developing methods for drug residues in aquacultured products with the validation of a multiresidue method for multiple fish species being completed.
CVM researchers identified a new metabolite which will allow for the development of a method for detection of ivermectin in fish products.
CVM published online a freely accessible database of literature for researchers and regulators and designated the PhishPharm Database, detailing drug metabolism, residues, and pharmacokinetics in multiple fish species.
CVM provided data to support the development of two international antimicrobial susceptibility testing standards published in July 2006 that have been accepted as an Official Method by the Clinical Laboratory Standards Institute, providing the first internationally recognized standards for AST of aquatic bacteria.
Ensure Food Safety – Field Activities
Counterfeit Veterinary Drugs: In July 2006, seven individuals and two businesses were indicted in the Eastern District of Washington on 175 charges related to a conspiracy to sell and distribute counterfeit, adulterated and misbranded animal drugs. These counterfeit animal drugs, which originated in Mexico, were intended to be used in the treatment of infectious diseases in cattle, swine and poultry. The charges included trafficking in counterfeit drugs, and money laundering. Asset forfeiture in the amount of $1.4 million is being sought.
Protect Against Bio-Terrorism
In FY 2006 CVM supported FDA’s strategic goal to improve product quality, safety, and availability through better manufacturing and production oversight by protecting the public from bio-terrorism. With the base resources CVM is able to demonstrate results in five areas:
CVM scientists developed methods to detect the presence of toxins, drugs, pesticides, and other substances that could be introduced into the U.S. animal feed supplies by bioterrorists.
As part of the Strategic Partnership Program Agroterrorism initiative, CVM performed vulnerability risk analysis on export grain elevator operations in New Orleans with USDA, FBI, and industry during an immediate post-Katrina situation to harden soft targets against terrorist attacks and tampering.
CVM traveled to Nebraska and conducted vulnerability assessment of major cattle feedlot operations with USDA, FBI, and the State that produced a document for the industry that assists industry in protection from deliberate attacks, exotic animal diseases, and harmful chemicals that may have devastating economic consequences
CVM correlated information on a secret level for the National Veterinary Stockpile and drugs within the Strategic National Stockpile to leverage capabilities and avert shortages.
In December 2005, the CVM Veterinarian published an article entitled “Federal Agencies Partner with Private Industry for Bioterrorism Vulnerability Assessment,” which outlines our strategy and offers a mechanism to volunteer to participate in this effort.
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