Former U.S. Food & Drug Administration (FDA) Associate Chief Counsel Kristin Kaplan joins Shook, Hardy & Bacon, further expanding the firm’s regulatory capabilities. Kaplan has a deep understanding of regulatory issues and the nuances of the government agency after advising FDA for eight years and serving an in-house role at a global leader in animal health. “Her combined FDA insight and in-house experience make Kristin invaluable as we deepen our regulatory capabilities,” said Shook Chair Madeleine McDonough. “It is critical for our clients facing litigation to align with our regulatory team to anticipate and address developing legal developments.” Kaplan counseled FDA on a variety of issues, including new animal drug applications stemming from biotechnology and recalls of foods, animal foods and drugs. She later became Deputy General Counsel for one of the world’s largest animal health leaders, where she provided strategic insight on various issues including regulatory, compliance, and health, safety…
Tag Archives animal/pet meds
A recently released Natural Resources Defense Council (NRDC) report suggests that the U.S. Food and Drug Administration (FDA) has allowed 30 potentially harmful antibiotic additives to remain approved for use in food animals (cows, pigs and chickens), even though the agency’s own scientists found that “none of these products would likely be approvable as new additives for nontherapeutic livestock use if submitted today, under current FDA guidelines.” Titled “Playing With Chicken,” and based on a review of previously undisclosed FDA documents, the report notes that (i) 18 of the 30 antibiotic feed additives reviewed were assessed as posing a “high risk” to human health; (ii) drug manufacturers did not submit sufficient information on 12 of the additives to establish safety; (iii) despite the fact that 29 of the additives are not proven to be safe, no action has been taken to withdraw approval; and (iv) 26 of the additives have never…
The U.S. Food and Drug Administration (FDA) has announced plans to phase out the use of certain antibiotics in food animals as part of its effort to reserve medically important drugs for the treatment of human infection. Noting that voluntary participation “is the fastest, most efficient way to make these changes,” the agency will partner with industry to discontinue the practice of adding these drugs to animal feed and drinking water as a growth promoter. To this end, FDA has issued final guidance that urges animal pharmaceutical companies “to voluntarily revise the FDA-approved conditions on the labels of these products to remove production indications,” in addition to proposing an updated veterinary feed directive (VFD) “to facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements for the distribution and use of VFD drugs.” “The plan also calls for changing the current over-the-counter (OTC) status to bring…
The New York State Parent Teacher Association (PTA) has reportedly become the first PTA in the country to pass a resolution that calls on Congress and the U.S. Food and Drug Administration “to protect human health by prohibiting the overuse and misuse of antibiotics in food animal production.” Representing hundreds of thousands of parents, teachers and students who note that “antibiotic resistance has become a global public health crisis,” the group’s resolution supports legislation that would improve labeling on meat and poultry products and make antibiotic use on the farm more transparent. The resolution also (i) advocates public disclosure on the amount, type and purpose of antibiotic use during food animal production; (ii) encourages schools to serve meat and poultry from farms that use antibiotics only to treat disease; and (iii) supports education for parents and schools on how antibiotic use in livestock production contributes to antibiotic resistance. See Pew…
The U.S. Department of Agriculture’s Food Safety and Inspection Service and the Food and Drug Administration have announced an August 5, 2013, public meeting in Washington, D.C., to provide information and receive public comments on agenda items and draft U.S. positions for discussion during the 21st Session of the Codex Committee on Residues of Veterinary Drugs of the Codex Alimentarius Commission in Minneapolis, Minnesota, on August 26-30, 2013. Agenda items include a report on World Organization for Animal Health activities; proposed draft maximum residue limits (MRLs) for veterinary drugs; proposed draft guidelines on performance characteristics for multi-residue methods; and a discussion paper on MRLs and other limits in honey. See Federal Register, June 20, 2103. Issue 488
SHB Pharmaceutical & Medical Device Practice Chair Madeleine McDonough and Associate Lael Awong have co-authored a chapter in a Food and Drug Law Institute (FDLI) primer titled FDA’s Regulation of Veterinary Drug Products. Researched, referenced and edited by experienced professionals, FDLI primers are designed to be practical and user-friendly. McDonough and Awong contributed to the “Human Food Safety” chapter, which addresses Food and Drug Administration (FDA) regulations aimed at ensuring that food is safe for human consumption regardless of the use of an animal drug in a food-producing animal. They explain how veterinary drug sponsors can meet FDA requirements for the analysis of drug residues in food-producing animals in the preparation of new animal drug applications. The primer is available for purchase on FDLI’s website.
The Center for Science in the Public Interest, Consumers Union and Food Animal Concerns Trust have sent a letter urging U.S. delegates to an upcoming U.N. food standards agency meeting about residues of veterinary drugs in food to ask other countries to stop using drugs that have long been prohibited for use in the United States due to “human health concerns, particularly carcinogenicity and mutagenicity.” The drugs in question include carbadox, nitrofural, furazolidone, chlorpromazine (thorazine), stilbenes (e.g. diethylstilbestrol, DES), olaquindox, dimetridazole, ipronidazole, metronidazole, and ronidazole, and according to Food Animal Concerns Trust Director Steven Roach, they are “not needed for animal health” and most countries have adopted safer alternatives. “We urge the U.S. delegation to insist on a recommendation that other countries prohibit use of these drugs, as the U.S. itself does,” said Roach. See Consumerist, August 21, 2013.
Citing a shortage of naturally raised beef due to last year’s drought, Chipotle Mexican Grill Inc. has apparently told media sources that it may allow its restaurants to begin using beef treated with antibiotics. Although Chipotle only reached its goal to use antibiotic- and hormone-free meat a few years ago, the company reportedly said that it plans to review its “never-ever” antibiotic policy and possibly allow suppliers to sell animals that have been treated with antibiotics “when necessary.” The policy change would still bar the use of beef from animals given antibiotics to prevent disease or promote weight gain. “Many experts, including some of our ranchers, believe that animals should be allowed to be treated if they are ill and remain in the herd,” Chipotle founder and co-CEO Steve Ells was quoted as saying. “We are certainly willing to consider this change, but we are continuing to evaluate what’s best…
The American Public Health Association’s 141st annual meeting and exposition is slated for November 2-6, 2013, in Boston, Massachusetts. Expected to attract more than 13,000 physicians, researchers, epidemiologists, and related health specialists, and featuring a myriad of presentations, the meeting will include a session on “Regulating for the Public’s Health: Food and Beverages, Drugs, and Emerging Technologies.” Among the presentations during this session are the legal considerations of antibiotics in food animals, focusing on a court order requiring that the Food and Drug Administration (FDA) complete proceedings to withdraw approval of certain antibiotics (presented by Centers for Disease Control and Prevention senior attorney Heather Horton), and “Legal strategies to increase funding and improve the FDA’s authority over food labeling violations and questionable claims” (presented by Rudd Center for Food Policy and Obesity attorney Jennifer Pomeranz). Pomeranz contends that FDA lacks sufficient authority and funding to address misbranded food products and “[t]he…
Sens. Kirsten Gillibrand (D-N.Y.), Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) have introduced bipartisan legislation to combat antimicrobial drug resistance by requiring the Food and Drug Administration (FDA) to report more information on the annual sales of antibiotics used among industrial farm animals. The “Antimicrobial Data Collection Act” would also reportedly give the agency a deadline to finalize policies proposed in 2012 that would eliminate the use of antibiotics for growth-promoting uses. “Antimicrobial resistance is a public health concern that needs to be adequately addressed,” Gillibrand said in a statement. “Increased data collection, transparency, and accountability are part of a comprehensive solution that will help protect American citizens from drug resistant microbes, saving lives and tax dollars.” “Our bill would not create any new reporting requirements for drug companies, feed mills, or farmers. It would only require the FDA to provide more transparency in reporting the antimicrobial data which is already being reported to it,”…
