The Food and Drug Administration (FDA) has announced an initiative to address “the prevalence of animal drug products marketed in the United States without approval or other legal marketing status.” Unapproved animal drugs on the market include injectable vitamins, shampoos, liniments, and electrolyte and glucose solutions. FDA is concerned that the safety and effectiveness of these drugs has not been demonstrated and is open “to using both the agency’s existing authority and new approaches to make more drugs legally available to veterinarians, animal producers and pet owners,” according to a December 20, 2010, press release. The agency requests comments by February 18, 2011, on ways to increase the availability of legally marketed animal drugs and has launched a web page detailing problems involving the use of unapproved products. See Federal Register, FDA Press Release, December 20, 2010.
Tag Archives veterinary drugs
In advance of the August 30-September 3, 2010, session of the Codex Committee on Residues of Veterinary Drugs in Foods, draft U.S. positions will be considered during a public meeting scheduled for August 16. Written comments may be presented during the meeting or forwarded to the U.S. delegate to the Codex session, Dr. Kevin Greenlees, who works in the Office of New Animal Drug Evaluation at the Food and Drug Administration (FDA). Among other issues on the upcoming Codex agenda are (i) draft maximum residue limits for veterinary drugs (at step seven of an eight-step Codex process), (ii) a discussion paper on methods of analysis for these residues in foods, (iii) a draft priority list of veterinary drugs requiring evaluation by a joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) expert committee on food additives, (iv) a discussion paper on veterinary drugs in honey production, and (v) a discussion…
The U.S. Department of Agriculture’s (USDA’s) Office of Inspector General (IG) has released a report, which finds that the federal government’s “national residue program is not accomplishing its mission of monitoring the food supply for harmful residues” of veterinary drugs, pesticides and heavy metals. According to the report, federal agencies have failed to establish thresholds for “dangerous substances” such as copper or dioxin, an omission that “has resulted in meat with these substances being distributed in commerce.” The IG also found that USDA’s Food Safety and Inspection Service (FSIS), which is responsible for the national residue program, “does not attempt to recall meat, even when its tests have confirmed the presence of veterinary drugs.” Among other matters, the report calls for (i) better coordination among FSIS, the Environmental Protection Agency and the Food and Drug Administration; (ii) an expansion of the substances these agencies test for; (iii) improvements to the…
The Food and Drug Administration (FDA) has submitted a proposed collection of information involving antimicrobial animal drugs to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. According to the Federal Register notice, a 2008 amendment to the Federal Food, Drug, and Cosmetic Act requires that “the sponsor of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals.” The first report under the law will be due March 31, 2010, and must specify (i) “The amount of each antimicrobial active ingredient by container size, strength, and dosage form”; (ii) “quantities distributed domestically and quantities exported”; and (iii) “a listing of the target animals, indications, and production classes that are specified on the approved label of the…
U.S. Representative Louise Slaughter (D-New York) has asked the Government Accountability Office (GAO) to review federal efforts to collect data on antibiotic use in animals. In a letter to Acting Comptroller General Gene Dodaro, Slaughter asked for the study because a 2005 GAO report found that the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) were not collecting data “on the types and amounts of antibiotics used in different species of food animals or whether the antibiotics were used to promote growth, prevent disease, or treat disease.” Slaughter, who chairs the House Committee on Rules, also introduced a bill earlier this year to restrict the non-therapeutic use of antibiotics in animals raised for meat, citing claims that animal antibiotic use has made some antibiotics less effective in treating human health problems. Her letter requests that GAO find out…
The American Veterinary Medicine Association (AVMA) has submitted a report to Congress that challenges the 2008 findings of the Pew Commission on Industrial Farm Animal Production, which supports legislation (H.R. 1549 and S. 619) seeking to prohibit or limit the use of low-level antibiotics in agriculture. Signed by 20 food producer organizations, an introductory letter states that the Pew Commission and other supporters of the Preservation of Antibiotics for Medical Treatment Act (PAMTA) “offer no new information or data to make their case, but rather echo inaccurate messages.” The signatories have called on the Obama administration to honor its pledge to base its regulatory decisions on “the best available science,” not the opinions of “PhD issue advocates or animal rights activists.” AVMA specifically faults the Pew Commission for failing to “incorporate the findings and suggestions of a significant number of participating academicians.” Focusing on the areas of antimicrobial resistance, the environment…
The Vermont Supreme Court has refused to expand liability to allow the recovery of non-economic damages in litigation involving the death of pets. Goodby v. Vetpharm, Inc., No. 2009 VT 52 (Vt., decided May 8, 2009). While the issue arose in a case involving the alleged negligence of a veterinarian and pharmaceutical company, the question whether pain and suffering damages are available to pet owners also came to the fore when melamine-contaminated pet food injured or killed cats and dogs throughout the United States and Canada in 2007. Shook, Hardy & Bacon Public Policy Partner Victor Schwartz and Associate Phil Goldberg submitted an amicus curiae brief to the court on behalf of the Animal Health Institute, Federation of Dog Clubs, American Kennel Club, and Pet Industry Joint Advisory Council, analyzing the legal and public policy implications of allowing such damages. The brief explained to the court how this proposed liability would depart from hundreds…
The Office of the Acting Deputy Undersecretary for Food Safety, U.S. Department of Agriculture and U.S. Food and Drug Administration have announced a public meeting on April 29, 2009, to discuss draft U.S. positions for the 18th Session of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) slated for May 11-15, 2009, in Natal, Brazil. CCRVDF works to (i) establish “priorities for the consideration of residues of veterinary drugs in foods”; (ii) “recommend maximum levels of such substances”; (iii) “develop codes of practice as may be required”; and (iv) consider methods of sampling and analysis for the determination of veterinary drug residues in foods.” The session will include agenda items related to (i) the “registration of veterinary medicinal products”; (ii) “draft guidelines for the design and implementation of national regulatory food safety assurance programs”; and (iii) a “draft priority list of veterinary drugs requiring evaluation or reevaluation.”…
The Food and Drug Administration (FDA) has apparently prevailed in proceedings seeking injunctive relief against two New Mexico dairies that “were not keeping adequate medication records to prevent unsafe drug residues in cattle offered for slaughter” and “were using medications for unapproved indications not specified on the drug label” without a valid veterinarian-client-patient relationship. The companies, Do-Rene and Clover Knolls Dairies, were warned about these violations in 2005 and 2008 following inspections and tissue sampling. Apparently, some of the dairies’ cows tested positive for illegal levels of a number of drugs, including one “expressly forbidden for use in lactating cows.” According to FDA, “These residues may cause allergic reactions in extremely sensitive individuals, and they may contribute to forming antibiotic-resistance in bacteria.” Future violations may result in civil or criminal penalties. See FDA Press Release, January 2, 2009.
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