The website of pet supply retailer Little City Dogs in the Bronx, NY, makes some rather compelling sales pitches to consumers who want to treat their dogs and cats for common ailments without having to pay the high prices charged by their local veterinary clinics. "Try our Little City Dogs Flea Killer. It contains nitenpyram, the same active ingredient as in Capstar at 75% off the regular price!" said the scroll running atop Little City Dogs' homepage recently.
Turns out it's not exactly legal for pharmacies like Little City Dogs to mass-market cheap copies of veterinary drugs like Capstar, which is made by Novartis ($NVS) Animal Health. Now the FDA has informed the company of the violation, via a harshly worded letter the agency posted recently on its website. Because the company has formulated the medicines under its own brand names, they are technically new drugs, the letter explains, but "the products are unsafe" because they haven't been through the normal FDA review process.
"Because your products are intended to prevent, mitigate or treat disease in animals or to affect the structure or function of the body of animals, they are drugs," the letter says. The company was given two weeks to comply with the law and provide documentation to the FDA of the steps that it took to do so.
In addition to marketing a drug with the same ingredient as Capstar, Little City Dogs sells a de-worming drug that's similar to brands such as Droncit from Bayer, and a flea-control product that includes an ingredient in another Novartis product called Program. The FDA's letter points to several other examples, which is says constitute a mere "sampling of the violative products."
It is not necessarily illegal for companies such as Little City Dogs to make their own versions of popular drugs. The practice, known as "compounding," is actually quite common in veterinary medicine, where drugs used for people are often tailored for pets--in smaller doses or flavored liquids that are palatable to dogs and cats. But those products are supposed to be made for individual patients, and not mass marketed over the Internet.
The FDA's warning to Little City Dogs follows a string of actions the agency has taken on the human side, where compounded medications are facing new scrutiny. The agency continues to battle with NuVision Pharmacy of Dallas over products that have failed sterility testing, for example. The agency has sent several warning letters to compounders in the wake of the meningitis outbreak linked to the New England Compounding Center (NECC) in 2012, after which FDA Commissioner Margaret Hamburg came under fire for not exercising enough oversight with compounders. Some pharmacies have signed up for a new compliance program run by the FDA, though the program is entirely voluntary.
- here's the FDA's warning letter