Former FDA associate commissioner Peter J. Pitts added his voice to calls for the need to regulate animal drug compounders who put together illegal animal drug combos, accusing the FDA of doing nothing while animals are dying from the practice. It comes as the American Veterinary Medical Association (AVMA) is looking into how to regulate animal drug compounding.
In a piece for The Hill on July 16, Pitts said illegal drug compounds with fatally high amounts of pyrimethamine, an antiparasitic, are commonly made and dispensed to mimic approved products. And he asked the reader to envision the horror of horses thrashing with seizures--a "real-life nightmare" for trainers in Kentucky--a recent tragedy from the use of compounded drugs that left four animals dead and others paralyzed.
"For several approved animal drugs, FDA has sent warning letters to these pharmacies, but often they were simply ignored and the illegal practices continued," Pitts wrote. "...The FDA must do more and commit to strong and sustained enforcement to protect animal health."
Some compounders attempt to copy and mass produce an FDA-approved drug with a far lower price tag. While the FDA is taking few actions against these compounders, Pitts illuminated that the "law is clear: FDA and three federal appeals courts have ruled that compounding animal drugs from bulk substances is illegal. Period."
The AVMA last month formed its Task Force on Veterinary Compounding Legislation to combat illegal compounding. The team is comprised of 8 vets aiming to update the compliance policy guide "Compounding of Drugs for Use in Animals" by the end of the year, as well as push legislators for new policy on on veterinary compounding.
"The formation of the task force is timely, considering the recent events in the equine community and the national attention given to the topic both in Congress and by the federal government," the organization wrote when the task force was announced.
- here's Pitts' piece in The Hill
- and here's some clarification from the AVMA