Disease Du Jour: Pioneer, Generic, Compounded, and Counterfeit Animal Drugs 

Understanding the regulatory pathway behind animal health products helps veterinarians evaluate safety, efficacy, and reliability when making treatment decisions for patients. In this episode of the Disease Du Jour podcast, Stephanie Batliner, VP of Regulatory Affairs and R&D North America for Bimeda, discussed how FDA-approved drugs, compounded medications, and veterinary devices fit into the equine health care landscape. She also talked about the growing concern of counterfeit drugs in the equine space.  

This episode of Disease Du Jour is brought to you by Bimeda.  

New Animal Drug Application for Pioneer Drugs 

Batliner explained that a New Animal Drug Application (NADA) is the regulatory process used to move a pioneer drug forward for FDA review and approval. This pathway establishes safety, proves efficacy, and ensures manufacturers can produce the product reliably and consistently. A drug sponsor conducts dose determination studies, target animal safety studies in horses, clinical and field efficacy trials, and environmental assessments. They also must demonstrate strict chemistry and manufacturing controls. That information is then reviewed by the FDA Center for Veterinary Medicine. 

Batliner said this process can take anywhere from five to 10 years, depending on the complexity of the drug and the condition being treated. “It’s quite an arduous process, but it builds in a lot of credibility and safety to those products that are FDA-approved,” she said.  

Abbreviated New Animal Drug Application for Generic Drugs 

The Abbreviated New Animal Drug Application (ANADA) is the pathway that allows generic animal drugs to enter the market after a pioneer drug has already been approved. “That approval process would prove to FDA that your product is bioequivalent to the pioneer,” she said. “It contains the same active ingredient, it works in the same way at the same doses in the same route of administration, and it has the same safety and efficacy profile as the pioneer.” 

Some products can prove equivalence in laboratory settings, while others require bioequivalence trials in animals. Batliner clarified that even though the application is abbreviated, “all the same rules are in place for generics as for pioneer drug products in terms of how they’re manufactured.”  

Once a generic is approved, it can be marketed on its own merits. If the pioneer drug exits the market, the generic can continue to be sold. Batliner explained that there are far fewer generic drugs in veterinary medicine than in human medicine.  

Pharmacy-Compounded Products 

Unlike pioneer and generic drugs, pharmacy-compounded products are not reviewed or approved by the FDA. Batliner explained that compounded medications have a legitimate role when no approved drug exists or when the approved formulation is not appropriate for a specific case. Pharmacy compounders may take an active ingredient or an approved drug and reconfigure it into a dosage form more suitable for a particular animal or situation. 

“They haven’t undergone the same rigor and review by FDA that pioneer and generic approved animal drugs have,” Batliner said. She advised veterinarians to learn as much as possible about a compounding pharmacy’s quality controls and recordkeeping before making prescribing decisions. 

Veterinary Devices 

Veterinary devices are items that do not change the structure or function of the body, such as bandages, braces, or inhalation masks. Unlike drugs, devices are not formally approved by the FDA before they enter the market. “In the event that a device is causing real harm, FDA does have the regulatory authority to react, but for a veterinary device to come forward and be offered for public use, they do not need to get an FDA approval up front,” Batliner explained. 

Counterfeit Drugs 

Batliner also discussed the growing concern of counterfeit drugs in the equine space. Counterfeit products are designed to look like FDA-approved drugs, sometimes closely enough that customers struggle to identify the difference. “We have no idea what’s actually in the container,” she warned. “We don’t know if it’s been tested, we don’t know if it’s safe, we don’t know if it’s efficacious.” 

Batliner said counterfeit equine products are often sold through online retailers rather than established veterinary distribution channels. Red flags include misspellings on packaging, missing lot numbers or expiration dates, and poor print quality on labels. She noted that counterfeiters sometimes copy contact information directly from approved labels, which can further complicate identification. 

If a veterinarian suspects a product is counterfeit, Batliner recommended reporting it through the contact information on the packaging, directly to FDA, or back through the supplier to investigate the source. 

Final Thoughts 

In closing, Batliner said the FDA approval process should give veterinarians confidence in treatment outcomes and product performance. Listen to the podcast episode to learn more. 

About Stephanie Batliner 

Stephanie Batliner is currently serving as VP of Regulatory Affairs and R&D North America for Bimeda, a global animal health company that is passionate about providing solutions to optimize the health and wellbeing of animals. She has 30+ years of experience in the animal drug industry, working with the FDA Center for Veterinary Medicine with a focus on chemistry, manufacturing and controls, and generic animal drugs. Stephanie is also Chairperson of the Generic Animal Drug Alliance, an industry trade association. She holds a bachelor’s degree in animal science from the University of Missouri-Columbia. 

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