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Monday, September 23, 2013

Veterinary Compounding 101, Part 2: Bayer Sues and Wins Against Pharmacy for Deceptive Trade Practice-Supplier of Unapproved Bulk and Compounder offering Commercially Available Replicas


September 23, 2013
by Sue Tuck Richmond

Introduction

In Part 1,What the Inspection Process Has Missed, And How the Blame is Shared By All- the FDA, the State Boards of Pharmacy, the Pharmacies, the Pharmacists, and the Veterinarians, I discussed some general information and topics regarding veterinary compounding. In part 2, I will address another hot topic-replication of commercially available drugs.  This problem is one constantly being battled by Pharmaceutical Companies as has been evidenced by some of the more recent lawsuits filed by pharmaceutical companies against compounding pharmacies.  In 2005 Bayer Health care did a presentation at the AAVPT 14th Biennial Symposium on this issue:





During that presentation, Bayer noted that since 2000, it had notified Center for Veterinary Medicine (CVM) division of the FDA of numerous violations by pharmacies and of suppliers of unapproved bulk active ingredients, but for most part not action was taken.  As part of its presentation, Bayer offered the following chart of pharmacies compounding products in violations of laws, rules and regulations and to which and an FDA complaint had been filed but no action was taken:

Bayer sues Tabor and Kalchem

Finally in 2003, Bayer filed a civil lawsuit against 
Tabor Home Medical Services and Kalchem International Inc., both of Lindsay, Oklahoma, for deceptive trade practices for offering to sale a drug product posing as an equivalent to Baytril 100 injectable solution.  More specifically, the civil action charged that Tabor and Kalchem knowingly purchased counterfeit enrofloxacin from illegal sources, manufactured unapproved material, and misrepresented the product as Baytril and Enrofloxacin to veterinarians and cattle producers. 

Bayer Wins in Court

On May 5, 2004, Bayer HealthCare LLC's Animal Health Division on received a favorable court order in its lawsuit for deceptive trade practices on Baytril 100. The court order includes monetary damages in the amount of $400,000, which equaled the proceeds received by Tabor and Kalchem from the sale of enrofloxacin.  In addition, the court order granted a permanent injunction prohibiting Tabor and Kalchem from buying or selling enrofloxacin. Bayer Animal Health and the FDA were allowed to take possession of the counterfeit enrofloxacin drug substance currently on hand at Kalchem International Inc. and properly destroyed it.

Questions

How many pharmacies that compound veterinary drugs are making illegal replicas of commercially availables?  Why do state boards of pharmacies not shut down these pharmacies or at least fine them and obtain injunctions to stop this production of drugs?  Does the FDA currently have authority to do anything about this problem?  If the FDA does currently have authority, why aren't they taking action?  Will the new federal legislation address this problem in the veterinary compounding world (remembering that pharmacy is pharmacy and what applies to human compounds typically applies to animal compounds pursuant to state laws, rules and regulations)?  Why are veterinarians not properly trained and educated about these types of compounds being illegal?  Who should train them?  Who should be liable if a vet is in possession of illegal commercially available compounded preparation? The pharmacist who compounded it? The pharmacist in charge? The pharmacy? The vet? The sales or marketing rep? 

In future post covering Veterinary Compounding, I will examine some of the companies on the Bayer list and discuss current lawsuits and disciplinary action pending against some of these companies.