October 3, 2013
Find out how to make the best choice between FDA-approved innovator drugs, FDA-approved generic drugs, medical devices or compounded products.
From AQHA Corporate Partner Adequan
When a horse or companion animal becomes sick or lame, you turn to your veterinarian for a diagnosis and the best, proven treatment to make your animal better.
But, just because a product is available for purchase doesn’t make it a proven product or the right product to treat the problem. So, do you treat with an FDA-approved innovator drug, an FDA-approved generic drug, a medical device or a compounded product?
In considering this question, Dr. Jeffrey Berk, a veterinarian at Equine Medical Associates in Lexington, Kentucky, says horse owners need to consider two things very carefully.
“When considering an alternative treatment, veterinarians and horse owners need to understand they are not guaranteed the same level of safety or quality — i.e. potency and purity — as you would with an FDA-approved product,” says Dr. Berk, who is a member of the Professional Conduct & Ethics Committee of the American Association of Equine Practitioners.
Some experts estimate that 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 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. All regulations are focused on protecting the end user and providing a safe, effective product. In short, the FDA will not allow a company to market a drug as FDA-approved if it has not proven its effectiveness in multiple scientific studies.
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The FDA reviews marketing claims and labeling for approved drugs, so the consumer has a clear understanding of what to expect. Check the medication administered to your horse. If it’s FDA-approved, it will have a package insert that explains 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.
FDA approval doesn’t end when the product is released to the market. Companies granted FDA approval for their drugs must continually demonstrate consistency, efficacy and good manufacturing processes, which includes plant inspections conducted by the FDA. Also, it’s mandatory for manufacturers of FDA-approved products to record and notify the FDA of any adverse reactions to their drug.
The price for an innovator drug can be high, and you may want to find a cheaper treatment, but Dr. Berk says it’s usually a lack of understanding that prompts this response.
“If you discuss the options with your veterinarian, and he recommends an FDA-approved drug instead of a device or compounded product, you should really consider his recommendation,” says Dr. Berk, who has practiced in Ohio, Florida and Kentucky. “I tell my clients, ‘Yes, you could use these products, but there are legal and liability issues involved, and you are not as likely to get a good outcome.’ When I discuss all the reasons for FDA-approved vs. medical devices and compounded products, very few clients want to use those other products.”
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 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. The marketing and labeling must be reviewed and approved so it doesn’t mislead the public. Even generic products will have a product insert in every box.
Not every innovator drug has a generic brand available to the market. For example, Adequan i.m. (Polysulfated Glycosaminoglycan) 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. Get the facts at nogenericadequan.com.
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“The medical devices have slipped through the cracks because there is no stringent approval process for them as long as they are used as medical devices,” says Dr. Berk. “Polyglycan is the classic example. Here is a medical device that is being used as a drug. What it’s supposed to be used for is a post-operative joint lavage. Nobody is using it that way. Everybody is using it systemically as a substitute for Adequan i.m. (Polysulfated Glycosaminoglycan) and/or Legend (Hyaluronate Sodium), which are FDA-approved drugs.”
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.
A veterinary medical device is 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 are available to veterinarians to treat a unique 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 a specific affliction.
“The problem we are seeing with compounded products is the compounding pharmacies are expanding their product lines to compete with FDA-approved products,” says Dr. Berk. “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.”
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Compounded products can vary greatly in their chemical makeup. At the 2010 AAEP convention in Baltimore, Dr. Scott D. Stanley and Dr. Heather DiMaio Knych presented a study on compounded drugs. They
studied seven different liquid variations of Pergolide Mesylate, with two bottles of each used in the study. They tested each bottle immediately after receipt and found
nine of the 14 bottles were lower than the FDA standard for potency. Even under proper storage, the study found that by Day 15, only three bottles contained an FDA standard equivalence for potency.
When considering a treatment option, it is important to know what the product is proven to do. Is it a drug that is proven to create a desired response, or is it a device that should be used as a final wash before closing up a wound or surgical incision? Is it a generic version of a successful product that is FDA approved, or is it a compounded product for a unique situation? Talk to your veterinarian to ensure that you are informed on the best treatment option for your horse.