A Bellevue man conspired to have drugs that were mislabeled or not yet approved for sale in the country imported and sent to online consumers in the U.S., federal investigators say.
In a complaint filed last week in U.S. District Court in Omaha, a special agent with the Food and Drug Administration described a years-long investigation involving undercover purchases on Karl Gross' website and sales of more than $2 million over eight years.
Gross is charged with wire fraud and causing the introduction into interstate commerce of misbranded drugs and the delivery of an unapproved drug.Â
He is set to make his first court appearance in the case in July.
In an affidavit in support of the criminal complaint, Eric Dickey, who works in the FDA Office of Criminal Investigations' Kansas City field office, said the investigation began in September 2013, when First National Bank contacted the office about Gross, who had opened an account in the name of Amerisave six years earlier, calling it a medical equipment sales business.
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Dickey said U.S. customers could use Amerisave's now-defunct website, worlddrugprices.com, to order foreign-sourced drugs.
The website purported to let consumers search for the "world's lowest drug price," claiming they were manufactured at FDA-inspected and approved plants and of "exactly the same quality as the brand names" but at lower prices.
On June 6, 2016, a federal search warrant was executed as Gross' home in Bellevue, headquarters for Amerisave.
Dickey said the investigation turned up records of transfers from Gross to a business selling health care products and pharmaceuticals in the United Arab Emirates and deposited checks that bore the name of FDA-approved prescription drugs, such as Crestor and Plavix and Symbicort, written in the memo section.Â
Between August 2007 and September 2015, deposits to the account totaled more than $2 million, the FDA investigator said.
He described making four undercover purchases using the website, each of which resulted in misbranded or unapproved drugs being sent to him from foreign countries.
Dickey said, for instance, in 2015 for $320 he got a 30-day supply of Pradaxa, which hadn't yet been approved by the FDA, shipped from Canada, and had ordered Advair but got a not-yet-approved generic shipped from Germany.
In another undercover purchase, this one in 2016, Dickey ordered a 90-day supply of Vytorin (patent protected at the time) for $145 and got a drug from Germany that hasn't been approved by the FDA and had no U.S.-approved equivalent, according to the affidavit.
In an interview, Gross allegedly told agents he had bought Amerisave in 2007 from another man who still owned and controlled the website and was responsible for the claims on it.Â
Gross described his duties as brokering prescription drugs from U.S. and foreign sources.
U.S. Magistrate Judge Michael D. Nelson signed the 13-page complaint against Gross last week.Â