Imagine waking up and finding your beloved pet on the floor convulsing, motionless or dead.
This was the real-life nightmare for horse trainers in both Lexington and Ocala, Fla. when they found their horses experiencing seizures and thrashing in their stalls. More than a dozen horses died or were severely injured, in some cases paralyzed, by illegally compounded medicines.
These horses were prescribed illegal drug concoctions that contained unsafe levels of pyrimethamine. By one account, 25 times the recommended amount, a deadly overdose.
There is legal and appropriate animal drug compounding. FDA-approved products may be modified (for example, adding flavorings, or turning tablets into a liquid) by a trained pharmacist on the order of a veterinarian to treat the medical needs of specific animals.
But some animal drug compounding pharmacies go far beyond those parameters, with deadly results. They mass produce and market drugs that mimic FDA-approved products, often using untested active ingredients, imported from countries that may not strictly control drug manufacturing.
These copies carry a cheaper price tag than approved drugs, but none of the consumer protection.
Why does this black market exist? It's both expensive and time-consuming to get FDA approval for a drug. For animal drugs, it can take up to 10 years and cost up to $100 million. But the process protects consumers and animals by ensuring that the approved drug is safe and effective.
FDA permits a limited amount of necessary compounding from bulk ingredients in order to make sure medical needs can be met when there is no approved drug. But these compounding pharmacies have taken the proverbial inch and run for murderous miles. Despite their attempts to muddy the waters with lawsuits and rhetoric, the law is clear: FDA and three federal appeals courts have ruled that compounding animal drugs from bulk substances is illegal.
The practice has caused harm to more than just horses. One university veterinary hospital has reported that dogs and cats are brought in, only to find they were being treated with illegally compounded drugs.
As a former FDA associate commissioner (and a current dog owner), I know the agency has rigorous enforcement authority. Pharmacies that engage in illegal manufacturing cannot be allowed to ignore the law and put animal health at risk in the name of selling a cheaper product.
For several approved animal drugs, FDA has sent warning letters to these pharmacies, but often they were ignored and the practices continued. Unfortunately there has been little to no follow-up by the agency. The FDA must have more strong and sustained enforcement to protect animal health.
What can you do? Talk to your veterinarian about treatment options for your pet. Ask if any drug being prescribed is FDA-approved. If not, and compounding is necessary, make sure the pharmacist preparing the compound has the credentials and license to do it safely and legally.
While that might sound obvious it is the only way to ensure the prescribed drug is what is best for your pet. If you have concerns about a pharmacy, check with your state board of pharmacy. At the same time, FDA must do its job of protecting our pets and animals by more regularly and aggressively enforcing the law and regulations.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a member of the Animal Health Institute's Board of Scientific Advisors.
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