Hi-Tech Pharmaceuticals President and CEO Jared R. Wheat, Vice President Stephen D. Smith, co-founder Tomasz Holda and Sales Associate Sergio Oliveira pleaded guilty last week to one count of conspiracy i.e “conspiring to violate federal prohibitions against mail and wire fraud and the importation and distribution of adulterated, unapproved, and mislabeled drugs.” The defendants admitted to the operation of a pharmaceutical manufacturing facility doing business as Planet Pharmacy in Belize where they produced generic versions of various prescription drugs which were sold without a prescription on the Internet (”Four “Hi-Tech Pharmaceuticals” Case Defendants Plead Guilty to Importing and Distributing “Knock-Off” Prescription Drugs,” August 18).

United States Attorney David E. Nahmias said of the pleas, “These defendants set up an offshore manufacturing facility where, in unsanitary conditions, they reproduced leading pharmaceutical products for importation into the United States, all without FDA approval or licensing from the rightful patent holders. Their motive in flouting the law, violating patents and exposing their customers to unknown health risks was greed, pure and simple. I commend the FDA and the DEA for their thorough investigation in this case. The Department of Justice and these agencies will continue to work hard to protect American consumers from such fraudsters.”

The U.S. Attorney did not mention that Planet Pharmacy, operating in Belize, could legally produce generic versions of drugs such as Xanax, Valium, Ambien, Vioxx, Lipitor, Zoloft, Viagra, Cialis, Anavar, Anadrol, Dianabol, Winstrol, Arimidex, Clomid, Nolvadex, etc. because of the existence of a loophole in Belize law. Planet Pharmacy believed they were legally operating as long as they did not directly market or distribute the products to residents of the United States.

(more…)