Drug Compounding Roundtable

Luitpold PR Roundtable

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TAKING ON DRUG PIRATES

Luitpold vs. Illegal Drug Compounders

Veterinarians don’t always have FDA-approved medications at their disposal for every illness and every animal species. As a result, compounding pharmacies must sometimes adulterate existing drugs, or compound prescriptions from scratch. Some compounding pharmacies go further, though, and essentially manufacture large batches of “copycat,” non-FDA-approved drugs for mass distribution.

Such drugs are a threat to animals, because they are not made to FDA quality standards. They are also a threat to the veterinary profession, because more and more pet owners are suing when things go wrong. Finally, they are a threat to future drug development, because pharmaceutical manufacturers are reluctant to develop drugs that can be easily copied.

Our client, Luitpold Animal Health, manufactures and sells Adequan®, a leading medication for the treatment of equine and canine degenerative joint disease (DJD). Luitpold needed to accomplish two objectives: to demonstrate industry leadership, and to take on the compounders who make “imitation Adequan.”

To get the industry’s attention, we organized and conducted a veterinary pharmaceutical roundtable discussion on compounding, with participation from six world-renowned equine practitioners, researchers and academics. We recorded the 2 ½-hour discussion, transcribed it, and got it published in its entirety (over 16,000 words) in two leading equine industry publications. Excerpts also appeared in three other publications.

We followed up by organizing a meeting of six equine pharmaceutical manufacturers at the annual convention of the American Academy of Equine Practitioners (AAEP). With consensus from these leading manufacturers, we approached the AAEP to begin a dialog.

Three months later, the AAEP formed a task force on illegal drug compounding, which immediately recommended a tougher stance on illegal compounders. AAEP subsequently banned the exposition of illegally compounded medications at its conventions. All compounders wishing to exhibit at AAEP’s conventions must now sign an agreement pledging to exhibit in compliance with FDA laws and AAEP rules, and violators will be forced to leave the convention floor.

The Food and Drug Administration has also responded, with enforcement actions against at least four alleged illegal compounders, and a new, stricter policy on compounding.

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