Avoiding the FDA approval process and FDA regulation of base ingredients allows the manufacturers of veterinary devices to market their products at less cost than an FDA-approved drug.
“I’ve spoken to veterinarians who say ‘I use them because of the cost,’ to which I reply ‘But then don’t you wonder what’s actually in it? Why don’t you just buy a bottle of water from me for $20 and say it’s a wonder drug,’” said Bertone. “That’s the problem with all of this. The drug companies spend a lot of money to develop these [FDA-approved] products, and then they find out there’s nobody to protect them.”
“If these companies can bring devices to market without bothering with FDA approval and sell plenty of the stuff, then eventually FDA approval will break down and we’re left with the Wild West,” said Joe Davis, DVM of Piedmont Equine Practice in The Plains, Va., an FEI-accredited veterinarian
“If that happens, when someone comes to my office and says to me, ‘This is a new drug; its the greatest thing,’ I can’t rely on the FDA approval process to inform me about the drug. I might have to say ‘Do I trust this company?’ How would I learn to trust that company? I would have to learn that by giving the drug to clients’ horses and discovering the adverse effects myself. I don’t want to do that.”
The bypassing of FDA approval has deeper effects as well. If some companies are circumventing FDA approval by producing veterinary devices that are being used by veterinarians as drugs in competition with FDA-approved drugs, “A pharmaceutical company’s motivation level to bring products to the market is diminished,” said Morehead.
“I think that all of us in this industry—not just veterinarians but all of the horse-owning public—need to think long and hard about that because whether you like pharmaceutical companies or not, we rely on them in the human and veterinary market. That may not be the biggest issue we see this year or next year, but at some point, we’ll all see repercussions from that as pharmaceutical companies elect not to bring new products to the market,” Morehead continued.
On The Honor System
For the moment, the FDA has chosen to adopt an “enforcement discretion” policy on the pharmaceutical use of veterinary devices, even though it violates their rules.
“The FDA regulates many important issues. For example, our food supply is more important than this issue, and the monitoring of such is also, so certain things get priority,” said Morehead. “If horse production was for producing food, it would also be far higher on the priority list. But they’re not, so horses are a lower priority in the eyes of the FDA.”
So, it’s up to the veterinary community to self-police. And veterinarians are frequently under quite a bit of pressure from clients to find an effective, yet cheaper, treatment. And if their friend had good success with a veterinary device, the client might ask for the same.
“You have to decide if you’re going to do the best for your client and for the patient,” said Bertone. “It’s about the ethics of doing the right thing for your client. I don’t care if the FDA decides to do anything to enforce their rules about this. I doubt they will. But it’s about what my profession dictates to me is ethical behavior in delivering services to my client.
“It’s so important for the veterinarian to educate the client about all the facts and the risks,” Bertone continued.
A white paper produced by the Biological and Therapeutic Agents Committee of the AAEP in July 2010 stated that “it is the AAEP’s position that if there are FDA-approved products available and formulated in the appropriate dosage for the disease indication of the patient, those products should be used in preference to a medical device used as a pharmaceutical.” And that “It is unethical for a veterinarian to promote or represent a medical device as equivalent to an approved pharmaceutical product.”
There are a multitude of resources available online for horse owners seeking to educate themselves about their horses’ care and medications. “When you’re talking to your individual veterinarian in the privacy of your own barn aisle, that’s one conversation,” said Tom Daniel, DVM, of Southern Pines Equine Associates (N.C.).
“But if you really want to see what the profession as a whole thinks about that issue, go to the American Association of Equine Practitioners website and read up on it. Don’t be afraid to challenge your veterinarian’s position if it stands at odds with his professional organization’s stance.”