In others words, no outside authority is ensuring the quality and safety of veterinary devices. Using a medical device as a drug is NOT off-label or extra-label use. Off-label or extra-label use is when veterinarians are allowed to use drugs that are not FDA-approved for equine medicine. Off-label use applies only if those drugs are FDA-approved for use in another species or for a different disease or route of administration. Since human medical and veterinary devices have not undergone FDA drug approval, their use is not considered valid off-label or extra-label use.
Simply put, “It’s against the law to use a medical device as a drug,” said Bertone. “You should never use a medical device as a drug. You’re using something that is very substandard.”
Some horsemen refer to Chondroprotec as “generic Adequan” and MAP-5 as “generic Legend,” but this is incorrect. Technically, the FDA recognizes generic drugs if they’re identical in composition, safety, efficacy, and concentration to the name brand drug and manufactured after the name-brand drug’s patent has expired. And true generic drugs undergo the same FDA testing and approval as the name-brand approved drugs. These medical devices have not proven themselves to be identical to the name-brand, FDA-approved drugs, nor have the undergone the FDA approval process.
In an address he gave at the 2004 American Association of Equine Practitioners Convention, Wayne McIlwraith, BVSc, PhD, DSc, FRCVS, DMV, Dipl. ACVS, the director of Colorado State University’s Gail Holmes Equine Orthopaedic Research Center, discussed Chrondroprotec in particular.
“It has been commonly represented as generic Adequan, but it is not,” he said. “This is both illegal and unethical. The fact that the company calls the product Chondroprotec [which implies cartilage protection] and packages it in a container-closure system that is identical to that used for an injectable product is an extreme example of misrepresentation.”
You Get What You Pay For
What does an FDA-approved drug have that a veterinary device doesn’t? In a word, regulation.
During the FDA approval process, a drug is studied intensely to determine its stability, efficacy, sterility and consistency. The facilities of FDA-approved drug manufacturers are inspected and monitored. The base ingredients of an approved drug are evaluated for purity and consistency.
The manufacturer of a veterinary device does not have to submit a pre-market approval application to the FDA, their product does not undergo any testing for efficacy, stability, or sterility, and their manufacturing locations do not have to be registered with nor inspected by the FDA.
According to the FDA specifications about veterinary device regulation, “It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.”
The process of FDA approval is expensive, and so are quality ingredients. “FDA approval is actually peanuts in cost versus what it takes to buy a chemical in a form that you know exactly what that chemical is,” said Bertone. “The biggest problem is meeting the specifications of a drug, and that means it’s not contaminated, it’s the strength it’s supposed to be, and it’s stable. It’s so difficult to meet that standard, but it makes sense that it’s supposed to meet that standard.”
FDA-approved drugs have not only proven their efficacy, safety, sterility and consistency of concentration of the drug, but they are also monitored after release to the market.
“There’s lots of oversight for an FDA-approved medication,” said James Morehead, DVM, of Equine Medical Associates PSC in Lexington, Ky., who has served on the AAEP’s Professional Conduct and Ethics Committee. “There are much higher quality standards applied than if you just come up with a drug.”
The FDA has a reporting process in place for approved medications—veterinarians are required to report adverse effects such as an infection in a post-injected joint. Adverse effects from veterinary devices have no central reporting process. In the case of an adverse reaction to the use of a veterinary device as a drug, the treating veterinarian is on shaky ground liability-wise.
“If I use an FDA-approved product on a horse and there’s an adverse reaction, I have a company backing me up. You, as the horse owner, have a company backing you up. You’ve got lots of people on your side trying to resolve this adverse reaction,” Morehead said.
If a veterinarian uses a veterinary device as a drug, which is in violation of FDA regulations and against AAEP recommendations, they assume more of the liability risk.
“Our professional liability insurance trust is there to defend us and they do so no matter what is going on,” said Morehead. “But you can imagine they have some issue with it if I, as a veterinarian, am out practicing illegally. What the insurance carrier would like is for all of us to practice at the top of the level all the time, and strive to do the best job that can be done. And obey the law.”
But an adverse affect doesn’t have to be as dramatic as an infected joint or a death. If the medication simply isn’t effective, that’s also an adverse effect, a silent one. “The hardest thing to show is that a drug doesn’t work. When we talk about adverse responses, like injecting something into a joint and having it explode, those are actually the really rare adverse responses,” Bertone said.
“The worse case, and the most common, is when the patient is not improving because of lack of efficacy of the treatment. That’s a lot harder to point at than a horse that has a dramatic reaction.”
An Erosion Of The Authority