The Council of the European Union has issued a “One Health” perspective document recognizing that antimicrobial resistance (AMR) “is accelerated by excessive and inappropriate use of antimicrobial agents” and asking member states to “develop and implement national strategies or action plans for countering AMR.” According to the perspective document, which underlined the need for “an active holistic approach” to combating AMR, “some practices in human and in animal healthcare including the possible incentives deriving from the prescription and subsequent sale of antimicrobial agents may lead to inappropriate use and overuse of antimicrobial agents.” In particular, the Council has advocated restrictions on both the human and veterinary use of critically important microbials (CIAs) and newly developed microbials “with the aim in the future to reserve CIAs as much as possible for human use.” To this end, the Council has requested that member states curb the prophylactic use of all antimicrobials while…
Tag Archives animal/pet meds
A federal court in New York has determined that the Food and Drug Administration (FDA) arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of proceedings to withdraw approval from certain uses of antibiotic drugs in livestock. Nat. Res. Defense Council v. FDA, No. 11-3562, (S.D.N.Y., decided June 1, 2012). The ruling follows the court’s March 2012 grant of summary judgment to the plaintiffs on their first claim for relief. Additional information about that ruling appears in Issue 432 of this Update. The most recent ruling relates to the third claim for relief, that is, whether FDA violated the Administrative Procedure Act when it denied the two petitions “requesting that the FDA withdraw approval of certain uses of certain classes of antibiotics in food-producing animals.” The court first determined that it had subject matter jurisdiction over the claim, disagreeing with FDA’s assertion that its November 2011 decision…
University of Almeria researchers have reportedly used a new “multi-residue” technique to identify veterinary drug residues in baby food, raising concerns about the need to better regulate the substances permitted in animal-based products. M.M. Aguilera-Luiz, et al., “Multiclass method for fast determination of veterinary drug residues in baby food by ultra-high-performance liquid chromatography tandem mass spectrometry,” Food Chemistry, June 2012. The study’s authors evidently analyzed 12 meat products containing beef, pork or poultry and nine milk powder samples, all of which purportedly contained trace amounts of antibiotics, including sulfonamides and macrolides, as well as anthelmintics and fungicides. In particular, the results allegedly showed higher concentrations of veterinary drug residues in chicken and other poultry products. “The concentrations detected have been generally very low,” one of authors was quoted as saying. “On one hand, this suggests they are not worrying amounts, on the other hand, it shows the need to control…
The Food and Drug Administration (FDA) has released industry guidance and a draft regulation about a new voluntary initiative intended to decrease the use of antimicrobials in agricultural animals. According to an April 11, 2012, press release, FDA has issued final guidance for industry titled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” which “recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.” The agency has also published draft guidance that urges animal pharmaceutical companies to voluntarily remove “production uses of antibiotics from their FDA-approved product labels” and “add, where appropriate, scientifically-supported disease prevention, control, and treatment uses.” These two sets of guidance are supplemented with a proposed veterinary feed directive outlining “ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible…
The Food and Drug Administration (FDA) has announced the availability of industry guidance concerning drugs for veterinary care. The guidance provides “recommendations on what documentation to submit to support the CMC [Chemistry, Manufacturing, and Controls] information for fermentation-derived intermediates, drug substances, and related drug products for veterinary medicinal use.” Noting that a variety of products are manufactured from fermentation processes, such as “competitive exclusion products” that consist of one or more microorganisms intended to prevent harmful bacteria like Salmonella from colonizing, FDA has requested comments on the guidance at any time. See Federal Register, March 8, 2012.
The U.S. Food and Drug Administration (FDA) has issued a final rule prohibiting the extra-label use of cephalosporin antimicrobial drugs in livestock. Citing “evidence that certain extralabel uses… will likely cause an adverse event in humans,” the agency has specifically barred using cephalosporins (i) “at unapproved dose levels, frequencies, durations, or routes of administration”; (ii) “in cattle, swine, chickens, or turkeys that are not approved for use in that species (e.g., cephalosporin intended for humans or companion animals)”; and (iii) “for disease prevention.” The final rule, however, still permits the use of an older drug, cephapirin, while allowing veterinarians to oversee limited extra-label cephalosporin use “in cattle, swine, chicken, or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label.” “We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account…
After a coalition of advocacy organizations filed a lawsuit against the Food and Drug Administration (FDA) seeking an order compelling the agency to rule on 1999 and 2005 petitions that asked the agency to withdraw approval of certain antimicrobial drugs in food animal production, the agency finally acted. Information about the lawsuit appears in Issue 396 of this Update. According to November 7, 2011, letters addressed to the Center for Science in the Public Interest (CSPI) and Environmental Defense, “the Agency has decided not to institute formal withdrawal proceedings at this time and instead is currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.” FDA contends that withdrawal proceedings can be protracted and consume significant agency resources. While the agency notes that it shares the petitioners’ “concern about the use of medically important antimicrobial drugs in food-producing animals for…
The Food and Drug Administration (FDA) recently announced the availability of its draft Foods and Veterinary Medicine Strategic Plan 2012 – 2016, which takes into account “all of the activities within the jurisdictions of the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine and includes activities supported by the Office of Regulatory Affairs.” According to the executive summary, the Foods and Veterinary Medicine (FVM) Program aims to protect the American food supply by securing high rates of compliance with science-based food safety and labeling standards as well as implementing “integrated, prevention-oriented and risk-based programs.” To this end, the 2012-2016 plan identifies one cross-cutting goal—to “improve effectiveness and efficiency across all levels of the FVM program”—as well as seven program goals: (i) “Establish science-based preventive control standards across the farm-to-table continuum”; (ii) “Achieve high rates of compliance with preventive control standards domestically and internationally”; (iii) “Strengthen…
Asserting that its technical animal drug-regulation amendment is not subject to congressional review, the Food and Drug Administration (FDA) has issued a final rule that increases the allowable residues of progesterone in edible tissues of cattle and sheep to reflect revised daily consumption values in a 1994 guidance document. According to the Federal Register notice, “Progesterone is approved for use in subcutaneous implants used for increased rate of weight gain in suckling beef calves and steers and in vaginal inserts used for management of the estrous cycle in female cattle and ewes.” The rule took effect on September 19, 2011, when it was published.
Alleging that tissue samples from Virtue Calves veal sold for slaughter since 1995 have contained illegal drug residues, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has sued the producer and its owners in a California federal court seeking an order to stop the defendants from selling food containing an unsafe new animal drug, deemed adulterated under federal law. United States v. Virtue, No. 11-902 (E.D. Cal., filed June 22, 2011). According to the complaint, FSIS identified in defendants’ veal calves desfuroylceftiofur, gentamicin, neomycin, penicillin, tetracycline, sulfadiazine, and sulfamethoxazole. While the latter two drugs have never been approved for use on any animals, the remaining drugs have no legal tolerances approved for use in calves, according to FSIS. The agency contends, “Defendants have a long history of illegal drug residues in the edible tissues of the veal calves they sell for use as human food.” The defendants were…
