By Wes Siegner –
On December 20, 2010 FDA published a notice requesting comments on how the agency can address a “problem” that has existed since the 1960s, when the Federal Food, Drug, and Cosmetic Act ("FDC Act") was amended in to require premarket approval.
The problem is simple. Because the FDC Act requires approval of animal drugs for every different use for every different species, there is simply no market to justify the research, development and approval costs for most animal drugs. Over 50%, and perhaps as many a 80%, of all animal drugs on the market are unapproved, estimates that we recently confirmed in a call with officials from FDA’s Center for Veterinary Medicine.
FDA and Congress have sought various ways to solve this problem with little or no effect, most recently in 2004 with the Minor Use and Minor Species Animal Health Act. FDA’s Notice serves as a warning to veterinarians, animal owners and industry that FDA is again seeking ways to restrict the marketing of unapproved animal drugs. This effort could make it impossible to obtain drugs that consumers and veterinarians know are useful, but that FDA wants to remove because of a lack of data to support FDA approval.
Affected parties should, therefore, urge FDA to act cautiously and not remove products from the market unless there is a clear and identifiable safety issue. Comments are due by February 18, 2011.