HEALTH: FDA urges halt to nontherapeutic uses of antibiotics in livestock, poultry
F
DA HAS MADE it clear to the animal agriculture
industry that feeding animals antibiotics for growth promotion poses a serious public health threat. In draft guidance published last week, FDA recommended that the industry stop using antibiotics that are medically important to humans unless they are necessary for animal health and are given with veterinary oversight. The agency stopped short, however, of issuing regulations to prohibit the use of antibiotics to increase production or enhance growth of farm animals. FDA is hoping that farmers will adopt the guidelines voluntarily, but such hopes have not materialized in the past. The guidance aims to help reduce antibiotic resistance in humans, which is worsening because of misuse and overuse of antibiotics in animal production. “To preserve the effectiveness of these important antimicrobial drugs, we simply must use them as judiciously as possible,” Joshua M. Sharfstein, principal deputy
J&J TEAMS WITH KOCH INSTITUTE ALLIANCE: Five-year pact will
focus on cancer biology and diagnostics development
A
NOTHER PHARMACEUTICAL firm is deepen-
ing its ties with academia. Johnson & Johnson, through its Ortho-McNeil-Janssen Pharmaceuticals subsidiary, has signed a broad, five-year oncology research pact with MIT’s David H. Koch Institute of Integrative Cancer Research. The collaboration, which the partners are calling “Transcend,” will delve into cancer diagnostics, the origins of cancer, genetic models of disease, and profiles of a tumor’s microenvironment. J&J says the appeal of partnering with Koch is its dual expertise in biology and engineering, which could accelerate development of new technologies and therapeutics. Koch scientists will submit research proposals to a joint steering committee, composed of three representatives each from J&J and Koch, which will select projects to fund. J&J is funding the research over the five-year period, providing an undisclosed up-front payment and the potential for follow-up investments.
commissioner of FDA, noted at a June 28 briefing. “Today’s draft guidance provides general principles and key first steps for achieving that goal,” he said. It also sets the foundation for potential future regulations, but FDA would not comment on when those next steps might happen. The agency has attempted to ban the use of antibiotics in animal production for decades, but its efforts have been derailed by Congress under pressure from industry. The pressure is likely to continue. The National Pork Producers Council issued a statement questioning the science on which FDA based its draft guidance. The industry group also expressed concern that the document could “lead to the elimination or costly review of previously approved animal health products.” Some members of Congress and public health advocates were also not pleased with FDA’s announcement. Rep. Louise M. Slaughter (D-N.Y.), who has introduced legislation (H.R. 1549) that would phase out nontherapeutic uses of some antibiotics in food-producing animals, stressed that FDA has “not gone far enough or moved fast enough.” Likewise, Laura Rogers, project director of the Pew Campaign on Human Health & Industrial Farming, urged FDA to “define and regulate what constitutes judicious use” and “move expeditiously toward the issuance of regulations.”—BRITT ERICKSON
The deal with Koch is part of J&J’s push to look outside its own labs to accelerate drug discovery and development. Last fall, the company created offices of external innovation for each of its therapeutic areas. The goal is to establish closer ties with academic institutions. “We realized that if we keep trying to do it alone, we won’t get as far as we can if we find academic collaborations where we can have a broad approach and combine the strengths of both organizations,” says Kristen Von Seggern, J&J’s vice president of external innovation for oncology. The pact between J&J and Koch is one of a growing number of alliances between industry and academia (C&EN, Nov. 10, 2008, page 13). Although companies have historically funded individual academic researchers on single projects, the new collaborations are meant to tap more broadly into academia’s strengths in basic science. AstraZeneca, Merck & Co., and Pfizer have in recent years forged pacts in specific therapeutic areas with institutions such as Harvard and Columbia Universities. In May, Pfizer went a step further and said it would give a longtime partner, Washington University in St. Louis, unprecedented access to information on existing drug candidates in hopes of finding new uses for the molecules.—LISA JARVIS
WWW.CEN-ONLINE.ORG
9
J U LY 5, 20 10
Pork producers claim that FDA’s draft guidance could eliminate antibiotics that are key to animal health and food safety.
ELLENZWEIG/MIT
SLOWING ANTIBIOTIC RESISTANCE
SHU T T ERSTO CK
NEWS OF THE WEEK
An artist’s rendering of Koch’s new labs, which are set to open in December.
