When a horse or companion animal becomes sick or lame, the owner turns to his trusted veterinarian for a diagnosis and the best proven treatment to make his animal better. However, what is prescribed might not always be the best option, as when a lavage solution is injected systemically. So do you treat with an FDA-approved drug, a generic drug, a medical device or a compounded product? In considering this question, Jeffrey Berk, VMD, a veterinarian at Equine Medical Associates in Lexington, Ky., says two things need to be considered very carefully. “You need to consider the safety of the patient and the liability or legal issues regarding the use of those products,” says Dr. Berk, a member of the Executive Committee of the American Association of Equine Practitioners. FDA-Approved Products “It’s important for veterinarians to understand that they are not guaranteed the same level of quality, i.e. potency and purity, that you would be with an FDA-approved product,” Berk says. “And if there is a therapeutic failure, the veterinarian has more legal exposure when treating with medical devices or compounds than when he treats with FDA-approved products.” Some experts estimate it takes four to six years and millions of dollars to get an FDA-approved animal drug from the laboratory to the marketplace. Most of the money is spent on conducting studies that will prove the drug’s effectiveness in a form acceptable to the Food and Drug Administration, the governing body over both human and animal drug approval. The FDA approval process is the most extensive law of its kind in any country. Regulations are focused on protecting end users and giving them safe, effective products. The FDA will not allow a company to market a drug as FDA approved if it has not proved its effectiveness in multiple scientific studies. The FDA reviews marketing claims and labeling for approved drugs, so the consumer has a clear understanding of what to expect. FDA-approved labels tell specifically where the drug should be administered, what the dosage should be for a specific species and what condition or disease the drug is supposed to treat. Companies granted FDA approval for their drugs must continue to demonstrate consistency, efficacy and good manufacturing processes; this includes plant inspections conducted by the FDA. Also, it’s mandatory for manufacturers to record and notify the FDA of any adverse reactions to their drugs. Price can sometimes be an issue with the innovator drug, and some clients may not want to pay for it initially, but Berk says it’s usually a lack of understanding that prompts this response. “If you got into a discussion with your clients, which I do, it can be a 20 minute conversation,” says Berk, who started his 30-year veterinary career at racetracks in Ohio. “I tell them, ‘Yes, you could use these [other] products, but there are legal and liability issues and you are not as likely to get a good outcome.’ When I discuss all the reasons for FDA-approved versus medical devices and compounded products, very few clients want to use those other products.” Generic Drugs According to the FDA, a generic drug is bioequivalent to the innovator drug and is also FDA approved. The approval process is easier and faster for a generic drug than an innovator drug because the manufacturer doesn’t have to conduct preclinical or clinical studies. However, the manufacturer must scientifically prove that the generic drug performs in the same manner as the innovator drug. After a generic drug is approved, the manufacturer also must comply with the same regulations as the pioneer drug. Marketing and labeling must be reviewed and approved so they don’t mislead the public. Even generic products will have a product insert in every box. Not every innovator drug has a generic available to the market. For example, Adequan i.m. (Polysulfated Glycosaminogycan) has no generic equivalent. Because generic drugs are FDA approved, it is illegal to call a product the generic form of another drug when it has not been FDA approved as such. Medical Devices “Medical devices have slipped through the cracks because there is no approval process for them as long as they are used as a medical devices,” Berk says. “Polyglycan is the classic example. Here is a medical device that is being used as a drug. It’s supposed to be used as a post-operative joint lavage. Nobody is using it that way. Everybody is using it systemically as a substitute for Adequan i.m. and/or Legend (Hyaluronate Sodium), which are FDA-approved drugs. Using a device instead of an FDA-approved drug can really compromise a veterinarian’s liability should something unfortunate occur.” According to the FDA, a medical device is an instrument, machine or implement that can be used to diagnose, cure or prevent a disease, which does not achieve its intended action through chemical reaction or by being metabolized by the body. Simply stated, a device is not intended to change chemically or be absorbed by the body to achieve its purpose. Syringes, lavages, prosthetics and shock-wave units are examples of medical devices. Veterinary medical devices are not approved or registered by the FDA. There are no premarket notification, premarket approval or mandatory adverse event reporting requirements. The FDA only oversees the misbranding, mislabeling and adulteration of veterinary medical devices. A medical device cannot be marketed as a drug or claim to work like one. Compounded Products Compounded products are available to veterinarians to treat a specific disease or address a unique situation. The FDA’s position is that it is illegal to compound in bulk and sell to third parties. Compounding is reserved for when there isn’t a commercially available drug that can properly treat an affliction. “The problem we are seeing is that some compounding pharmacies are expanding their product line to compete with FDA-approved products,” Berk says. “That is wrong and illegal. There are times when compounding is appropriate and good, and the basic criteria for compounding must always be met, i.e. the compounded product must be made for a specific patient to accommodate a specific need at a specific point in time.” Compounded products can vary greatly in chemical makeup. At the 2010 AAEP convention in Baltimore, Scott D. Stanley, PhD, and Heather DiMaio Knych, DVM, presented a study on compounded drugs. They studied seven liquid compounds of Pergolide Mesylate, with two bottles of each compound. They tested each bottle immediately after receipt and found nine of the 14 bottles were lower than the FDA standard for potency. The study found that even under proper storage, by day 15, only three bottles contained an FDA standard equivalence for potency. When prescribing a product to treat or prevent a disease, it is important to know what the product is proven to do. Is it a drug proven to create a desired reaction, or is it a device that should be used as a final wash? Is it a generic version of a successful product that is FDA approved, or is it a compounded product for a unique situation? The client depends on the veterinarian to make the ethical choice and inform them of the best treatment options for their animals. Ryan Curtis is an account executive at The Duff Co. in Kansas City, Mo. This Education Series article was underwritten by Luitpold Animal Health of Shirley, N.Y. <Home>
