U.S. Compounding, a company involved in marketing treatments to Thoroughbred racehorses and performance horses, has pleaded guilty to multiple fraud offences in federal court. This plea follows an alleged scheme involving fake prescriptions to facilitate drug distribution. The company, a subsidiary of DMK Pharmaceuticals Corporation, faces significant financial penalties, while one of its executives, Sam Glover, has been charged with conspiring to violate the Food, Drug, and Cosmetic Act (FDCA).
U.S. Compounding pled guilty to multiple fraud offences. The company is subject to a $4.2 million forfeiture payment and a potential criminal fine of up to $16.9 million. DMK Pharmaceuticals filed for Chapter 11 bankruptcy in February in Delaware.
Sam Glover, a former executive, is charged with one count of conspiring to violate the FDCA, carrying a maximum sentence of five years in prison. Glover has been arrested and will initially appear before a U.S. Magistrate Judge in the Eastern District of Arkansas.
Damian Williams, U.S. Attorney for the Southern District of New York: Emphasized the commitment to holding accountable those who violate laws ensuring drug safety and legality.
Christie Curtis, Acting Assistant Director in Charge of the New York FBI Field Office: Highlighted the alleged falsification of prescription orders and the scrutiny faced by company leadership.
The company allegedly arranged with a veterinarian to generate false prescriptions, allowing direct shipping of prescription drugs to consumers, violating the FDCA.
U.S. Compounding has marketed products to the horse racing industry, including a unique compound for managing ulcers in horses.
A 2017 press release from Adamis Pharmaceuticals Corporation (later DMK Pharmaceuticals) noted the marketing of the ulcer treatment to racehorses and hinted at performance benefits.
The charges date back to 2015 and focus on the alleged wrongdoing in the distribution of these compounded substances. The case underscores the legal and ethical responsibilities of pharmaceutical companies in ensuring the legitimacy and safety of their products.