Federal authorities want to stop bulk animal drug compounding by a Florida company that produced a compound connected with the April 2009 deaths of 21 polo ponies.
The Food and Drug Administration filed in April 2010 a complaint that accuses Franck's Compounding Lab of Ocala, Fla., of producing and selling unapproved animal-use drugs, including mimics of available pharmaceuticals. The agency was asking a federal judge for an injunction that would ban the company and its CEO, Paul W. Franck, from further compounding animal drugs from bulk ingredients.
"FDA recognizes the benefit of the traditional practice of pharmacy compounding—providing a service in response to a valid prescription to accommodate the specialized needs of a particular patient," Dr. Bernadette M. Dunham, director of the FDA Center for Veterinary Medicine, said in a statement. "But when compounders like Franck's circumvent, and thus undermine, the statutory drug approval process by manufacturing drugs under the guise of pharmacy compounding, we are concerned that poorly compounded drugs can jeopardize the health of animals."
Company officials released a statement indicating they will fight the complaint.
"The business of Franck's Compounding Lab is both legal and medically vital," company officials said. "Customized human and veterinary medicines—which we prepare pursuant to a verified prescription—meet the critical needs of doctors, veterinarians, and their patients that are otherwise unmet by off-the-shelf manufactured products."
An FDA Compliance Policy Guide published in 2003, "Compounding of Drugs for Use in Animals," states that the agency is concerned about the risks posed by veterinarians and pharmacists who manufacture and distribute unapproved new animal drugs with the intent of circumventing the drug approval process, thereby mass marketing products with inadequate standards to ensure purity, potency, and stability.
A new animal drug compounded from any unapproved drug or bulk drug substances without an approved new animal drug application is considered adulterated and illegal, the guidance states.
The FDA accuses Franck's of producing both adulterated and misbranded drugs, and the latter allegation asserts that company officials cannot meet label requirements because they don't have the animal and clinical data needed to write adequate directions for use of their compounded drugs.
The FDA complaint alleges that the agency discovered violations at Franck's Compounding Lab following the deaths of the Venezuelan polo team's ponies at the U.S. Open Polo Championship. It states that inspections in May, June, and December 2009 revealed that the company was illegally compounding drugs from bulk ingredients for use in animals.
The complaint states that Paul Franck responded to the agency that he disagreed with the FDA's interpretation of the law.
Following the ponies' deaths, an executive with Franck's said in a statement that a medication mixed by the company contained an ingredient with an incorrect concentration. The medication was given to the animals shortly before they died of an overdose of selenium. The team indicated in a separate statement that a Florida veterinarian had ordered a vitamin mixture similar to Biodyl, a Merial product that contains selenium and is used in Europe and Asia but is not approved for use in the U.S.
The FDA complaint also states that the agency issued a warning letter in 2005 and accused Franck's Compounding Lab of illegally compounding drugs from bulk pharmaceutical ingredients and shipping them interstate, compounding outside of valid veterinarian-client-patient relationships, compounding for third-party resale, and compounding for uses for which approved drugs were available.