The United States has filed a civil suit on behalf of the Food and Drug Administration (FDA) in U.S. District Court in the Middle District of Florida, against Franck’s Compounding Lab Inc., dba Franck’s Lab, a compounding pharmacy located in Ocala, Fla. The government alleges that Franck’s has been introducing adulterated, misbranded and unsafe drugs into interstate commerce as part of the company’s veterinary pharmaceutical compounding business, and has asked the court for a permanent injunction that would prohibit Franck’s and its CEO, Paul Franck, from using bulk pharmaceutical ingredients in its compounds. According to the government’s complaint, Franck’s compounded a drug mixture last year that killed 21 polo horses belonging to a Venezuelan team that was in Florida to compete for the United States Polo Championships.
Franck’s is in the business of drug compounding, which is the mixing, combining or altering of drugs to accommodate the particular needs of specific patients. Compounding is common in both human and veterinary medical industries, and the FDA and Department of Justice have long recognized that it is a necessary and valuable service. However, the agencies become concerned when pharmacies use compounding as a way to circumvent the regulatory requirements of the drug approval process and potentially put consumers and animals at risk.
Franck’s compounds drugs for human and veterinary use, but the suit for a permanent injunction only pertains to the company’s veterinary practices. In the past year, inspections at Franck’s have revealed that the company compounds most of its veterinary drugs from active pharmaceutical ingredients called "bulk" ingredients. This practice is prohibited by the statutes and regulations that govern veterinary compounding. Animal drugs created from bulk ingredients do not undergo FDA approval, and no clinical testing or other controls are in place to ensure their safety. The government alleges that Franck’s use of a bad mixture of bulk drugs a year ago led to the deaths of the 21 horses.
In addition to using bulk drugs for compounding, Franck’s also eludes the regulatory scheme by creating drugs that are compounded copies or near-copies of approved drugs that are already on the market. Franck’s distributes its drugs throughout the country. The company has refused to stop these practices in spite of several warnings from FDA that its activities were illegal.
"We allege that the practices at issue in this case contributed to deadly results," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "The Justice Department and our federal partners will work together to pursue pharmacies that put the health and safety of animals at risk."
Assistant Attorney General West noted that this case is the product of the cooperative efforts of the Office of Consumer Litigation in the Justice Department’s Civil Division, the U.S. Attorney’s Office for the Middle District of Florida and the FDA’s Office of Chief Counsel.