Here's something that could put a damper on Big Pharma's hopes for animal health businesses. The FDA is resuming its fight against the use of antibiotics in healthy farm animals, saying that the rising tide of resistant bacteria is "an urgent public health issue." The agency has begun by issuing a draft guidance, but is threatening new regulations if the ag industry doesn't voluntarily comply.
"[T]o preserve the effectiveness [of antibiotics, we simply must use them as judiciously as possible," Deputy Commissioner Joshua Sharfstein said on a conference call (as quoted by the Washington Post). "We have the regulatory mechanisms, and industry knows that. We also think things can be done voluntarily."
As the Post points out, the FDA has been trying to limit farm use of antibiotics for years, but opposition from pharma and the farm lobby has thwarted those efforts. This time, the agency is advising against giving antibiotics to stimulate growth, rather than treat sickness, plus advocating veterinary oversight of any use of the drugs in animals.
Over the past year, the animal-health business has attracted lots of attention from drugmakers. It's seen as one way to diversify away from human drugs as blockbusters approach the patent cliff. Most recently, Sanofi-Aventis and Merck re-established their animal health joint venture, Merial, with Sanofi investing $1 billion in the deal. And companies such as Bayer, Pfizer and Boehringer Ingelheim are eying the assets those companies might have to sell to get antitrust approval.