The Value Of FDA-approved Drugs

Price alone isn’t justification for using a compounded product, experts say.

They walk into your exam room—the fourth veterinarian to see Mugsy about his ears—in the hope that somehow you will have the magic concoction to make it all go away without costing as much as the other three veterinarians wanted to charge. 

Or, during a “strictly vaccination” clinic, the client asks what can be done for Bella’s green-encrusted eyes. Her regular vet told her they needed a very expensive ointment that must be used daily to prevent them from getting that way.

For any given scenario, you might luck out with a compounded home remedy. But there’s a substantial case to be made for advocating the treatments bearing the government label.Looking at the patient, knowing there’s a way to fix the problem, and knowing the client isn’t going to spend the money to fix it is a hard reality of veterinary practice.  No wonder some veterinarians want to believe there’s a cheaper way to achieve the desired result promised by federal Food and Drug Administration-approved veterinary drugs.

“What’s happening in our profession is that veterinarians are compounding as a way to get a cheaper product,” said Dawn Merton Boothe, DVM, MS, Ph.D., professor and director of clinical pharmacology at Auburn University in Alabama. “Veterinarians are legally empowered to use drugs extra-label and compounded drugs as well. But that does not absolve them from civil liability. Cost is not a justification for using a compounded product.”

Compounding doesn’t have to be a dirty word. The FDA Extra-label Drug Use regulations define compounding as a “customized manipulation” of an approved drug or drugs by a veterinarian or pharmacist to meet the needs of a particular patient. When you mix two injectable drugs, make a paste or suspension from crushed tablets, or add flavoring, you’re legally compounding. It is illegal, however, to mix homemade drugs from bulk or raw active ingredients.

“Compounding should not be used as a way of circumventing the drug approval process or producing a product so it can be sold for less cost than an FDA-approved drug,” says a brochure published jointly by the Animal Health Institute, the American Veterinary Medical Association and the American Veterinary Distributors Association.

Developing a major new animal drug takes an average of seven to 10 years and investment of up to $100 million by the sponsoring company, according to the Animal Health Institute website. Each new drug application goes to the FDA’s Center for Veterinary Medicine, where it is reviewed by veterinarians, animal scientists, biostatisticians, chemists, microbiologists, pharmacologists and toxicologists.

Clinical trials can take years. A key factor is the availability of animals with the condition being treated, noted J. Michael McFarland, DVM, Dipl. ABVP and group director of Companion Animal Division Veterinary Operations with Pfizer Animal Health. For example, animals infected with heartworm disease are more easily found than those with a rare form of neoplasia.

No Guarantees on Compounded Products
It’s called “manufacturing under the guise of compounding,” and it is a major compounding no-no.

“What we’re seeing now are not just compounded drugs; they’re being manufactured in large lots and distributed through distributors,” said Dawn Merton Boothe, DVM, MS, Ph.D., professor and director of clinical pharmacology at Auburn University in Alabama.

“There are so many points during the compounding process where mistakes can be made,” she said, including simple miscalculation of ingredients; whether the drug is thoroughly mixed with a vehicle and possible reaction with that vehicle; exposure to ultraviolet radiation; breaches in sterility and potency.

According to the Veterinary Compounding brochure published by the Animal Health Institute, American Veterinary Medical Association and American Veterinary Distributors Association, compounders are forbidden by law to develop a large quantity of a drug for sale to third-party veterinarians, companies or wholesalers who then resell it to individual patients.

Rather, a legally compounded drug is mixed on demand in response to a prescription for a specific patient.

“The veterinarian and/or pharmacist are then responsible for the safety and efficacy of the compounded drug,” the brochure states. “There is no assurance, like there is with an FDA-approved drug, that a compounded preparation will be safe or effective for the condition you are treating.”

Boothe, president of the American College of Veterinary Clinical Pharmacology, said that although individual state boards of pharmacy require compounding pharmacies to identify their drug sources, “There’s not really a regulatory environment to oversee them.”

Quality is “critically important” to the federal Food and Drug Administration approval process, she said. “It assures that what you get in that tablet is going to be stated on the label, and that the next lot will be the same, regardless of when it is purchased. With compounded drugs, you don’t have the guarantee of any of that.”

Boothe’s therapeutic drug-monitoring service at Auburn’s veterinary college puts her in the position to observe drug failures firsthand. One recent case was an animal under treatment with a compounded anticonvulsant drug. Her clinical pharmacology laboratory discovered “there was no anticonvulsant at all in that animal.” It turned out to be a drug obtained from a disciplined manufacturer, she said.

Finally, “Beware of pharmacies that purport to sell compounded preparations that are the same as commercially available FDA-approved products, or similar but with a minor difference, such as a slightly different concentration,” states the compounding brochure. “Often these are marketed as a cheaper alternative to the approved drug.”

As for gaining approval for use of a drug across different animal species, “In many ways you have to start all over at the beginning,” Dr. McFarland said. Each targeted species must go through a battery of trials.

“It takes several years and tens of millions of dollars to get a species on a label,” he said.

“Pharmacokinetics and pharmacodynamics can vary between species on a molecule-by-molecule basis,” he added.

One antibiotic may behave the same way in dogs and cats, while another antibiotic in the same class could affect the two very differently, McFarland said.

“There’s a lot of substrate for us to work with,” McFarland said. “There are more questions than answers.”

So, although some FDA-approved human drugs also have been labeled for animal use, it doesn’t automatically mean that a similar drug from the same class will achieve the same effect—and it may have unintended consequences.

Dr. Boothe, who is president of the American College of Veterinary Clinical Pharmacology, said she is “strongly opposed” to the use of human or compounded drugs when a veterinary drug for a condition exists.

“It’s a major disincentive for a drug company to go through the FDA approval process. It costs them millions of dollars,” she said. “Yet they’re the very companies that are going to support research and development of new veterinary drugs.

“I think we’re biting our noses off to spite our faces,” Boothe added, “when veterinarians make an end run around approved veterinary drugs.”

Stressing Pfizer’s “commitment to research and development and innovation,” McFarland said the corporation spends more than $300 million on R&D annually, plus nearly $4 million on collaborative research projects with U.S. veterinary colleges.

At the same time, Boothe acknowledged that “compounded drugs are critically important to the safe and effective management of disease in animals in the United States,” adding that sometimes size of the patient and need for alternative routes of administration call for a compounded solution.

“Many practitioners—and pet owners—ask for different dosage forms or strengths to enhance dosing and compliance,” noted Rebecca Sheehan, PharmD, general manager of Roadrunner Pharmacy, a compounder in Phoenix. “Some even ask for no-longer-available drugs. While FDA-inspected facilities are the most desirable source for active ingredients, some chemicals are just not available in this country and consequently, not generally inspected by FDA officials.”

Compounding pharmacies are licensed and directed by individual state pharmacy boards. The Pharmacy Compounding Accreditation Board in Washington, D.C., is a voluntary accreditation program of “quality standards and principles of the profession of pharmacy compounding” for which compounding pharmacies can apply.

“Practitioners should ensure that the pharmacy they are using is, first, licensed in its respective state and, second, has quality standards in place to satisfy your exacting standards,” Sheehan said. “To that end, we encourage practitioners to ask those hard questions. To know the country of origin for bulk powders is not nearly as meaningful as knowing what that pharmacy does with that powder to ensure its potency. Ask about the pharmacy’s quality program before you align with them.”

Said Pfizer’s McFarland: “At the end of the day, the most important difference between the branded product and a generic product is the company that stands behind the drug itself. … We are deeply committed to supporting the veterinary profession. Without their success, we have no reason for being.”

Dr. Epperley is an associate veterinarian for Southern Agriculture Inc. in Tulsa, Okla. Before earning her  DVM from Oklahoma State University in 1999, she worked as a journalist in Oklahoma City, covering business and political news.

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