Background by Dr. Daniel McChesney, Director, Office of Surveillance and Compliance, CVM
DR. McCHESNEY: Good morning and welcome. What I would like to do here is spend just a few minutes talking about the Center for Veterinary Medicine’s role in this proceeding, and specifically the Center -- the Office for Surveillance and Compliance, and I am going to do this just by putting up a couple of org charts to give you a feeling for what is going on.
As was said, the -- we are doing this -- well, I would say this part of the presentation is really to acquaint you with, well, how did the data that got to FDA, what was done with it? And, you know, who -- sort of, who is involved in that, and what is the structure?
So what we have up here is the overall structure of the office. I am the Office Director. Dr. Hartogensis is the Deputy Director. And down at the bottom you will see there are 3 divisions within us. And the total office is about 125 people.
The Division of Surveillance, on the far left, is really the group that deals with pharmacovigilance. Our Division of Animal Feeds does really all our animal feed issues, including pet food. The Division of Compliance provides regulatory support.
What we really -- since the Division of Surveillance is the group that really deals with pharmacovigilance, I would just like to spend a few minutes on this with this group.
There is a requirement for any adverse events associated with a product to be reported by the company to FDA. Now, there is not a requirement for anyone, for a physician or a veterinarian, for that matter, to report the adverse event to the company, so there is some underreporting, we believe, of adverse events. But having said that, all -- and individuals can also report to the company.
Having said that, all the reports that the company gets, whether it is on this product, ProHeart 6, or any other product, are submitted to FDA into the Center for Veterinary Medicine for veterinary products. And on an average year, we get about 35,000 adverse event reports, and those reports are associated with approximately 1700 approved veterinary drugs that are currently being marketed. Most, although not all, of the reports tend to be towards companion animals -- dogs, cats and horses -- although we do have reports for food animals.
So within that group, we have -- when those come in, we have a group that triages them by how long a drug has been on the market, the risk associated with the drug. They are logged in, and then they undergo a review by veterinarians to decide, is it related -- is whatever was being seen related to the drug or is it something else?
So the classic example is, well, you gave your dog some drug and it was hit by a car, well, it is probably not related to be -- that drug probably didn’t cause the dog to be hit by a car. Well, on the other hand, if that drug caused blindness in the dog and the dog was hit by a car, maybe there was association. So that is a very simplistic approach, but that is what we -- that is what our reviewers are trying to do, to say, is what we are seeing here, is it associated with the drug?
We have gone through that, and you will hear -- Dr. Baker later today will talk about what we have seen with this product and we will just focus on that product.
So after that is done, there are several options. When -- if we see a problem, then we can try to correct it through labeling or through risk mitigation strategy, and that is what we are really here today to talk about.
So, the 130 or 140 ADE reports that we received for this have all been screened by a variety of veterinary medical officers. We have data-mined with epidemiologists and so that is what we will be presenting today. And with that, I would like to stop and just really get to the meat of the meeting, and we will start off with a regulatory overview. And I think it is important that we have a regulatory overview because many times what we can -- the ability for FDA to do -- take action is limited by the regulatory framework we have to work in. So while we might agree, we would -- oh, if we looked at it from strictly as a scientific view, we would say, “Well, this is what we want to do, and, oh, we can go and do that, and that is the right thing to do.” Well, sometimes we are constrained on how much of that we can do, and we have to function within this legal framework. And I think the next presentation is really important for this meeting because it lays out that basis of the constrains, where we have to focus, what we have to do, and some of the limitations we have on ourselves.
So with that, I will turn it over to Janice.