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1. FDA Issues Revised Guidance on Veterinary Feed Directive Regulation Questions and Answers
Ctr. for Veterinary Medicine
September 29, 2015
The U.S. Food and Drug Administration (FDA) has issued revised Guidance for Industry (GFI) #120, "Veterinary Feed Directive Regulation Questions and Answers." The FDA has also posted to its website a list of states that have veterinarian-client-patient-relationship (VCPR) requirements for Veterinary Feed Directives (VFDs) and include the key elements of the Federally-defined VCPR, as well as those states that do not. This list was developed by FDA working together with state regulatory authorities. Veterinarians in states that do not require a VFD to be issued within the context of a VCPR that includes federally-defined key elements will be required to follow the federal VCPR requirements. The list may change over time as states update their veterinary practice requirements.
Revised GFI #120 reflects minor changes from the draft version of the revised guidance that was published for comment in June 2015 , including an additional question and answer about VFD authorization for pioneer and generic drugs, and clarification on how a veterinarian can authorize or limit the use of a VFD drug when used in combination with over-the-counter drugs.
In June 2015, FDA published a final rule that revised the VFD regulations. The revised guidance document released today includes revisions that are consistent with the requirements in the June 2015 VFD final rule and answers questions related to the final rule. The VFD final rule becomes effective October 1, 2015, and initially affects only those drugs that currently are approved as VFD drugs (avilamycin, florfenicol, and tilmicosin). Other feed-use animal drugs, specifically medically important antimicrobial products currently available Over-the-Counter (OTC), will be subject to these requirements when they are changed to VFD status as part of the Agency's judicious use initiative (see Guidance for Industry #213 for additional details). While some products may change sooner, FDA expects most changes to be implemented in a coordinated manner by January 1, 2017.
Although this guidance has been finalized, you can submit comments at any time. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2010-N-0155 in the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2010-N-0155 on each page of your written comments.
Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
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2. Farm Foundation workshops gather perspectives on VFD, antibiotic stewardship
By John Maday, Editor, Bovine Veterinarian
DroversCattleNetwork.com
September 29, 2015
Farm Foundation has been hosting a series of workshops in locations around the country to address upcoming changes to FDA rules and guidance relating to antibiotic use in food animals. The most recent of these was held in Denver on September 28. The workshops are designed to inform stakeholders of the implications of FDA Guidance to Industry 213 and changes to the Veterinary Feed Directive (VFD) rule.
Guidance 213 will remove performance or production claims from medically important antibiotics used in feeds by December 2016. Changes to the VFD rule will bring the use of medically important feed-grade antibiotics under the oversight of veterinarians by January 1, 2017. The new VFD rule actually takes takes effect this week on Oct. 1st, affecting the use of three antibiotics currently classified as VFD drugs. Those are Avilamycin, Florfenicol and Tilmicosin. Of those, only Tilmicosin is used as a feed-grade drug in cattle. As of January 1, 2017 the list of VFD drugs will expand to include all medically important antibiotics used in feed for prevention, control and treatment of disease. Cattle drugs affected at that time include Neomycin, Tylosin, Virginiamycin, Chlortetracycline and Oxytetracycline. Over-the-counter sales of those drugs will no longer be allowed, and producers will need to work through their veterinarian to obtain a VFD order.
Craig Lewis, DVM, MPH, DAVCM, a veterinary medical officer with the FDA's Center for Veterinary Medicine, addressed the workshop and provided background on the FDA's initiatives for judicious use of antibiotics.
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3. The Ruminant and Equine Antiparasitic Drug Use and Antiparasitic Resistance Survey is now open
FDA Ctr. for Veterinary Medicine
September 29, 2015
The Ruminant and Equine Antiparasitic Drug Use and Antiparasitic Resistance Survey is now open! FDA's Center for Veterinary Medicine encourages all bovine, equine, and small ruminant veterinarians and veterinary parasitologists to participate. The survey is intended to help the center better understand the level of awareness and concern within the veterinary community regarding antiparasitic resistance in grazing species. The survey will be open for five weeks, from September 29, 2015, to November 3, 2015. Responses will directly impact future educational outreach efforts to encourage the sustainable use of approved antiparasitic drugs and various strategies to slow the development of resistance.
The following professional veterinary groups will distribute the survey link to their members through online materials:
American Association of Bovine Practitioners (AABP)
American Association of Equine Practitioners (AAEP)
American Association of Small Ruminant Practitioners (AASRP)
American Association of Veterinary Parasitologists (AAVP)
American Veterinary Medical Association (AVMA)
If you're a bovine, equine, or small ruminant veterinarian or a veterinary parasitologist but not a member of one of the above five groups, please email Rita Viskup at rita.viskup@fda.hhs.gov for the survey link.
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4. Senecavirus A impacting neonatal mortality
By Daniel Linhares, Chris Rademacher, Zhang Jianqiang, Pablo Pineyro, Phil Gauger, KJ Yoon, Rodger Main, Iowa State University Veterinary Diagnostics Laboratory
National Hog Farmer
September 29, 2015
Neonatal piglet mortality is caused by different factors, including non-infectious and infectious conditions. Among the infectious conditions present in the United States, pathogens associated with substantial increases in mortality include porcine reproductive and respiratory syndrome virus and a few enteric pathogens as porcine epidemic diarrhea virus, transmissible gastroenteritis virus, rotavirus and E.coli. There might be another pathogen collaborating with neonatal mortality, as suggested recently in the Brazilian and U.S. swine industries.
Senecavirus A (formerly known as Seneca Valley virus) is a Picornavirus (small RNA virus), first identified as a cell culture media contaminant and proposed to be a non-pathogenic virus that has oncolytic properties and thus useful for cancer therapy in humans. However, Senecavirus A has also been frequently identified in pigs with idiopathic vesicular disease and therefore proposed as causative agent of vesicular disease in pigs.
Recently, case reports from Brazil and the Midwestern U.S. have identified Senecavirus A in cases of neonatal mortality. This column summarizes the current knowledge about Senecavirus A and the recently described neonatal losses syndrome.
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5. ACTION: APHIS Laboratory Approval Process - Request Comments by November 30, 2015
USDA Animal and Plant Health Inspection Service Bulletin
September 29, 2015
Veterinary Services (VS) is seeking comments on "A Proposal to Standardize and Consolidate the APHIS Laboratory Approval Process." This concept paper proposes actions to simplify regulatory oversight and compliance and clarify the laboratory approval process. The current authority and approval for animal diagnostic laboratories to test for diseases is comprised of multiple, unrelated, disease-specific regulations. Consolidating authorities and standardizing the approval processes would enhance transparency and make the approval process more user-friendly and efficient-whether the approval is to conduct testing for single or multiple diseases. The administrative burden associated with obtaining and tracking laboratory approvals, in addition to the steps required to renew an existing approval, would ultimately be minimized.
Consolidation efforts would include veterinary diagnostics regulated by APHIS, with the exception of diagnostics in the National Animal Health Laboratory Network and National Poultry Improvement Plan.
Please see: https://www.aphis.usda.gov/animal_health/downloads/conceptpaperforframework.pdf to review the concept paper. You may provide feedback to S.STAS.Feedback@aphis.usda.gov. All comments provided by November 30, 2015, will be considered.
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6. Latin American Countries Unite Against Avian Flu [edited]
ThePoultrySite.com
September 28, 2015
GLOBAL - The Latin American Poultry Association (ALA) has released a letter with a number of recommendations to unify the actions of Latin American countries in the fight against highly pathogenic avian influenza.
The letter, drawn from the debate started with ALA by the Brazilian Association of Animal Protein (ABPA) addresses issues related to biosecurity, risk analysis, active and passive epidemiological surveillance and health quarantine visitors to the farms.
The letter also deals with the consolidation of national regionalisation and compartmentalisation programmes and the creation of compensation funds.
One of the main points of the document is to create a Latin American Working Group, aiming to build a continental contingency strategy for the genetic material supply guarantee. The group consists of representatives from four geographical regions of the continent: Mexico, Central America and the Caribbean, the Andean Region and the Mercosur countries.
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7. Drug Compounding for Animals: FDA Could Improve Oversight with Better Information and Guidance
Report - GAO-15-671
September 28, 2015
What GAO Found
Drugs compounded for animals offer certain medical benefits but also pose risks of causing harm or being ineffective. Specifically, drugs compounded for animals can serve as treatment options when no suitable drug approved by the Food and Drug Administration (FDA) is available. For example, no FDA-approved drugs exist to treat megacolon-a potentially lethal form of constipation-in cats, so veterinarians rely on a compounded drug for treatment. Drugs compounded for animals can also pose risks of serious harm or may be ineffective if they contain too much or too little of an active ingredient, according to scientific studies and veterinary experts. However, FDA has acknowledged that it is not practical for the agency to approve each drug compounded for every animal that requires one; as a result these drugs are not reviewed for safety and effectiveness. In addition, because states have primarily exercised responsibility for pharmacies that compound drugs for animals, the states and not FDA generally review pharmacy compounding processes.
The extent to which drugs are compounded for animals is unknown because the information FDA and states collect is not aggregated or comprehensive for various reasons. First, unlike animal drug manufacturers, drug compounding pharmacies do not have to register with FDA. Second, although FDA and states try to share information about drug compounding pharmacies with each other, due to some states' privacy and confidentiality laws this information sharing is impacted. For example, FDA officials told GAO that some states are unable to share information about the results of their pharmacy inspections with FDA because of their states' privacy laws. Finally, FDA does not know the extent to which compounded drugs are associated with adverse events, in part because the form used to voluntarily report such events does not ask if a compounded drug was involved. Federal standards for internal control state that agencies are to obtain information from stakeholders that may have a significant impact on achieving its goals. By not asking for compounded drug information on its reporting form, FDA is missing an opportunity to inform its enforcement actions regarding animal drug compounding.
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