Pioneer drugs, generics, and compounded medications each play a role in equine practice. Understanding the regulatory pathways behind these drug categories can help veterinarians evaluate safety, efficacy, and reliability when making prescribing decisions.
Pioneer Drugs: The Path to FDA Approval
Pioneer drugs are the original, FDA-approved animal health products brought to market through the New Animal Drug Application (NADA) process. This pathway is designed to ensure a medication is safe, effective, and manufactured consistently.
To obtain approval, the drug sponsor must conduct dose determination studies, target animal safety studies in horses, clinical and field efficacy trials, and environmental assessments. They mustalso demonstrate strict chemistry and manufacturing controls. This information is presented to the FDA Center for Veterinary Medicine for review.
The NADA process typically takes five to 10 years, depending on the complexity of the drug and the condition being treated. This extensive review process helps establish confidence in pioneerproducts.
Generics: Same Safety and Efficacy, Lower Price
Generic animal drugs enter the market through the Abbreviated New Animal Drug Application (ANADA) process after an approved pioneer drug’s patent expires.
Generic manufacturers must demonstrate bioequivalence to the pioneer product. This means the generic contains the same active ingredient, works the same way at the same doses and route of administration, and has the same safety and efficacy profile as the pioneer drug. Depending on the product, bioequivalence can be established through laboratory testing or animal trials.
Although the application is abbreviated, generic drugs are held to the same manufacturing standards as pioneer drugs. Once approved, generics stand on their own in the marketplace and can be sold even if the pioneer product is discontinued.
Compounded Drugs: Filling a Need
Pharmacy-compounded products are not reviewed or approved by the FDA and do not undergo the same level of testing for safety, efficacy, or manufacturing consistency.
Compounding plays a legitimate role when no approved drug exists for a specific condition or when an approved formulation is unsuitable for a particular case. Compounding pharmacies may modify an active ingredient or an approved drug to create a dosage form better suited for a particular animal.
Because compounded products are not subject to FDA review, veterinarians should carefully assess a compounding pharmacy’s quality controls and recordkeeping before prescribing these medications.
Concerns Over Counterfeit Drugs
Counterfeit drugs are a growing concern in equine medicine. These products are designed to mimic FDA-approved drugs but may contain unknown ingredients that are untested, unsafe, or ineffective. Counterfeits are most commonly sold through online retailers rather than established veterinary distribution channels.
Warning signs include misspelled labels, missing lot numbers or expiration dates, poor print quality, and packaging inconsistencies. Some counterfeit products replicate legitimate contact information, making identification more challenging.
Veterinarians can report suspected counterfeit products to the FDA, the supplier, or through the contact information listed on the packaging.
Take-Home Message
Veterinarians can trust that FDA-approved pioneer and generic drugs are safe, reliable, and effective. Pharmacy-compounded products do not undergo the FDA’s rigorous approval process but have legitimate roles in some cases. Discuss these drug categories with your clients to help them understand which options are appropriate for their horses.
Brought to you by Bimeda.
Related Reading
- Disease Du Jour: Pioneer, Generic, Compounded, and Counterfeit Animal Drugs
- Unlocking the Power of Compounding in Veterinary Practice
- The Business of Practice: Veterinary Inventory Control
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