More manufacturing problems, more FDA action. This time it's Teva Pharmaceuticals in the stocks--but veterinary meds, not people drugs. The FDA announced late Friday that it had filed a consent decree requiring Teva Animal Health to get the agency's once-over and okay before making or selling any more animal treatments. The decree also prohibits the company and three executives from making and distributing "adulterated" veterinary drugs.
FDA said its inspectors had found "significant" violations of good manufacturing practice at the company's facilities in St. Joseph, Mo. "The FDA will not tolerate the manufacture and distribution of adulterated animal drugs," Michael Chappell, the FDA's acting associate commissioner for regulatory affairs, said in a statement. "Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate."
A Teva spokeswoman told Reuters that the loss of its animal drug sales doesn't have "any material impact" on the company. Teva "regrets the deficiencies in our manufacturing practices, and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements," the spokeswoman said.
As you know, the FDA is in the middle of a crackdown on drug manufacturing, with a series of similar actions, mostly against generic drugmakers. Ranbaxy Laboratories and Caraco Pharmaceuticals both had products seized and barred pending FDA inspection and approval of their manufacturing processes. The Teva action is based on inspections that run as far back as 2007. Will we see more action? Stay tuned.
- read the FDA release
- check out the story from Reuters