With a slap to French animal health company AB Science, the FDA is sending out a poignant reminder that there are no exceptions to its rules when it comes to marketing medications. It issued the company a warning letter regarding its Kinavet-CA1 canine drug, intended for mast cell tumors in dogs, for allegedly boasting its off-label uses without approval.
The warning letter calls the company out on marketing the drug for other conditions, including atopic dermatitis in dogs and asthma in cats. The FDA cites the drug's promotional materials as "false and misleading" and also slams AB for omitting vital facts about the drug. "This evidence that Kinavet is an unapproved new animal drug is particularly compelling," the warning letter reads.
The warning letter points to three specific documents in contravention to regulations. The first is a plug on the website touting its extra-label uses, while the second is a marketing promo with images of dogs that reportedly recovered from atopic dermatitis. The third is a solicitation to read a detailer on even more unapproved uses of the drug--treating lung, pancreas and colon cancer, and multiple myeloma.
AB also drew FDA ire for failing to mention how the drug affects humans in case of consumption--illuminating that it can cause birth defects and a slew of adverse reactions. The FDA writes AB "should immediately cease misbranding Kinavet-CA1" and threatens a seizure and injunction if the company doesn't comply.
AB, based out of Paris, developed Kinavet-CA1--a tyrosine kinase receptor inhibitor--after large studies on dogs in the U.S. and Europe. It received approval for the drug stateside in 2010.
- here's the FDA warning letter