The Ongoing Battle
Article Outline
This year's memories of the annual convention of the American Association of Equine Practitioners (AAEP) include beautiful weather, a great scientific program, and a bigger-than-ever trade show. On a personal note, my memories also include 5 days at Disney World with five grandkids and their parents.
One thing that was not new at AAEP was the ongoing discussion regarding compounders and ethical pharmaceutical companies. Having conducted research under good laboratory practice standards for numerous companies, and having helped register two pharmaceutical products through the Food and Drug Administration (FDA), I am certainly aware of the time, money, and agony that go into getting a product registered through the FDA. It is no wonder that few drugs are currently being registered. Spending $5 million to $10 million and taking numerous years to get a drug registered seems to be the norm. Why is it that registration of drugs can be done for a fraction of this cost in Australia and New Zealand? Pharmaceutical companies also seem to have very little protection from the compounders developing competitive products. One obvious solution is for the AAEP and the pharmaceutical companies to continue to hammer on the compounders to stay in line. Another solution would be to lobby for the FDA to become more reasonable in their requirements for drug registration, particularly if a drug is used in non−food-producing animals and particularly because there are no slaughterhouses still in operation in the United States. It may be that, if the cost of registering drugs were lower, more companies, including compounding companies, would choose to go the FDA route. This may seem a very naïve solution, but I think it is one that should be investigated.
PII: S0737-0806(07)00434-0
doi:10.1016/j.jevs.2007.12.005
© 2008 Elsevier Inc. All rights reserved.
