The U.S. Federal Trade Commission (FTC) conducted a day-long workshop, October 2, 2012, “to examine competition and consumer protection issues in the pet medications industry.” Currently pending before the House Subcommittee on Health, a bill (H.R. 1406) introduced in April 2011 by Representative Jim Matheson (D-Utah) would require FTC to issue rules mandating pet medication prescription portability, which could fundamentally change the way such products are sold in the United States. FTC seeks stakeholder input on issues that would affect a $7 billion per year industry and has extended the public comment period to November 1. An early step in FTC’s investigation, the workshop provided a forum for widely divergent views as veterinary professional advocates and representatives of the animal health industry addressed current practices limiting the distribution of pet medications and the potential impact of a change that would allow consumers to purchase the drugs from a full range…
Tag Archives animal/pet meds
The Federal Trade Commission (FTC) has reopened the comment period for its October 2, 2012, workshop on competition and consumer protection issues in the pet medications industry. The commission is “seeking the views of consumers, veterinarians, pharmacists, manufacturers, business representatives, economists, lawyers, academics, and other interested parties” submitted by November 1, 2012. FTC’s workshop agenda includes discussions on how pet medications are distributed to consumers and “how these distribution practices affect consumer choice and price competition.” See FTC News Release, September 19, 2012.
The Food and Drug Administration (FDA) has announced a draft compliance policy guide (CPG) concerning the “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats.” According to the September 10, 2012, Federal Register notice, the draft CPG explains how FDA plans “to use its enforcement discretion with regard to the labeling and marketing of dog and cat food products that are labeled and/or marketed as intending to diagnose, cure, mitigate, treat, or prevent diseases and to provide nutrients in support of meeting the animal’s total daily nutrient requirements.” Issued in response to new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the draft CPG seeks to address an observed increase in the number of cat and dog food products “that make labeling or marketing claims” about disease diagnosis, treatment or prevention. It also…
The Food and Drug Administration (FDA) has issued a final rule that amends regulations about concentrations of compounds of carcinogenic concern in the diet of food-producing animals and residues of carcinogenic concern in specific edible tissues. The changes clarify certain definitions “to enable the Center for Veterinary Medicine to consider allowing the use of alternative procedures to satisfy the DES [Diethylstilbestrol] Proviso without requiring the development of a second, alternative, set of terminology.” The changes take effect September 21, 2012. Among other matters, the amendment will change the existing emphasis in 21 CFR Part 500 on “no significant increase in the risk of cancer to the human consumer” to an emphasis on “the specific 1 in 1 million risk of cancer to the test animals approach.” See Federal Register, August 22, 2012.
A federal magistrate judge in New York has determined that the Food and Drug Administration (FDA) must begin proceedings to withdraw its approval of the use of certain antibiotics in livestock for non-therapeutic purposes on the agency’s timeline, thus denying FDA’s request for a stay while the matter is pending on appeal before the Second Circuit. NRDC v. FDA, No. 11-3562 (S.D.N.Y., decided August 8, 2012). In June, the court determined that FDA arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of these proceedings. More information about the case appears in Issue 442 of this Update. The magistrate first ruled on the Natural Resource Defense Council’s (NRDC’s) motion to strike a document from the record; it was an Animal Health Institute statement “expressing general support for the FDA’s plans to reduce the non-therapeutic use of medically-important antibiotics in animal feed through a voluntary guidance…
University of Melbourne researchers have reportedly demonstrated that viruses from two live-attenuated poultry vaccines have combined in the field to produce new infectious viruses “responsible for widespread disease in Australian commercial poultry flocks.” Sang-Won Lee, et al., “Attenuated Vaccines Can Recombine to Form Virulent Field Viruses,” Science, July 2012. According to a July 13, 2012, press release, two vaccines used simultaneously in chickens to control laryngotracheitis (ILT), an acute respiratory disease, apparently produced two new recombinant viruses that scientists then identified using whole-genome sequencing. Previous studies had apparently suggested that such recombination could happen under laboratory conditions but was unlikely in field settings. “We alerted the Australian Pesticide and Veterinary Medicines Authority (APVMA) to our findings and they are now working closely with our research team, vaccine registrants and the poultry industry to determine both short and long term regulatory actions,” a study co-author was quoted as saying. “Short-term measures include…
A federal court in Wisconsin has reportedly approved a consent decree between the U.S. government a Wisconsin livestock operation that allegedly violated federal drug laws by failing to maintain adequate animal treatment records, using new animal drugs illegally and failing to adequately distinguish between medicated and non-medicated animals for sale for use as human food. The Food and Drug Administration (FDA) initially warned the owner of Nolan Livestock in 2004 that a U.S. Department of Agriculture inspection revealed the presence of an illegal antibiotic in the edible tissues of its dairy cows. Under the consent decree, the owner must cease operations and then resume only when it has documented to FDA’s satisfaction that it has corrected the problems observed and has instituted appropriate procedures to prevent a recurrence. See U.S. Department of Justice News Release, June 26, 2012; FDA News Release, July 10, 2012.
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued a July 6, 2012, notice announcing its decision to restructure its National Residue Program to permit more extensive compound testing of meat, poultry and egg products. According to FSIS, the revamped program aims to reduce the number of samples analyzed while allowing the agency to assess more compounds per sample using improved multi-residue methods. In particular, these methods will enable FSIS to screen for pesticides and environmental contaminants as well as legal and illegal veterinary drugs such as antibiotics, anti-inflammatories and growth promoters. “Under the new system, one sample may be tested for as many as 55 pesticide chemicals, 9 kinds of antibiotics, various metals, and eventually more than 50 other chemicals,” explained the agency in a July 2 press release, which noted that the previous program required FSIS to collect one sample per animal and…
U.S. Representative Louise Slaughter (D-N.Y.) has released the responses to a February 16, 2012, letter sent to 60 food producers and retailers “asking them to disclose their policies on antibiotic use in meat and poultry production.” After analyzing the results, Slaughter has purportedly revealed that “while a small number of industry leaders provide antibiotic-free meat and poultry products, an overwhelming majority of food production companies routinely feed low-doses of antibiotics to healthy food-animals.” In particular, Slaughter has used these findings to bolster support for the Preservation of Antibiotics for Medical Treatment Act (PAMTA), “which would end the routine use of antibiotics on healthy animals” and “preserve the effectiveness of medically important antibiotics.” To this end, she has also highlighted a recent Consumers Union report, “Meat On Drugs,” as evidence that consumers would purchase antibiotic-free products in supermarkets. “Through my survey, the food industry has provided us valuable information, and with…
The Natural Resources Defense Council (NRDC) has filed a lawsuit against the Food and Drug Administration (FDA) and the Center for Veterinary Medicine (CVM) alleging that they have failed, in response to a Freedom of Information Act (FOIA) request, to produce documents pertaining to risk assessments for antibiotics used in livestock production. NRDC v. FDA, No. 12-4757 (S.D.N.Y., filed June 18, 2012). Seeking a declaration that the defendants violated FOIA and an order that they disclose “all responsive, non-exempt records to plaintiff within fifteen days,” NRDC refers to industry guidance that FDA issued in 2003 on “assessing the safety of antimicrobial new animal drugs with regard to the microbiological effects on bacteria of human health concern” and actions the defendants have taken since then relying on the guidance. After FDA acknowledged in a December 2011 Federal Register notice that it had begun “to look at the safety of some .…
