Posted: Apr 24, 2013 4:28 PM
MISSOULA - A Belgrade man accused of being involved with a company found to be selling fake cancer drugs pleaded guilty in federal court in Missoula on Wednesday.
Paul Daniel Bottomley, 48, is scheduled for sentencing on July 13. He is currently released on special conditions, according to a news release from the U.S. Attorney's Office.
In April 2010, the FDA began an investigation into unapproved cancer drugs at Montana Health Care Solutions, which was owned by Bottomley.
According to the U.S. Attorney's Office, the investigation found that Bottomley imported misbranded and unapproved cancer drugs from foreign countries and sold the drugs to American physicians, which violates the Food, Drug, and Cosmetics Act (FDCA).
According to the U.S. Attorney's Office, Bottomley sold MHCS to Canada Drugs, Ltd., an internet-based pharmacy corporation in Winnipeg in October 2010. Its subsidiary Rockley Ventures reportedly paid Bottomley $5 million for MCHS. Bottomley reportedly stayed on, acting as an advisor to Rockley Ventures and was paid $10,000 per month.
In January 2012, FDA was alerted regarding a potential counterfeit oncology drug, Avastin®, in the United Kingdom. The drug was determined to be counterfeit and traced back to MHCS, according to the U.S. Attorney's Office.
According to the U.S. Attorney's Office, some physicians and practice managers admitted to law enforcement that they knew the drugs were foreign versions of United States-approved products based on the price being charged as well as the packaging. For example, MHCS charged $1,700 per vial for Avastin®, when the product would normally cost nearly $2,300 per vial. Some physicians admitted that although they knew the drugs were foreign, unapproved versions of U.S. prescription drugs, they still billed insurance programs the prices they would bill for U.S. prescription drugs, the release states.
At the time of the shipments of the counterfeit Avastin® into the United States, MHCS was owned and operated as a subsidiary of Canada Drugs and Rockley Ventures. Canada Drugs and Rockley Ventures were responsible for the shipment of misbranded, adulterated and counterfeit drugs into the United States, all in violation of the FDCA, the release states.
Bottomley reportedly had no involvement in the importation and distribution of the counterfeit drug, he did become aware of the distribution of the counterfeit drug by January 2012, the release states.
In a separate civil proceeding, Bottomley agreed to forfeit to the United States $1,088,378.17 in United States currency, a 2011 Aston Martin/Vantage V-12 and 10 parcels of real property in Gallatin County, Montana. The property was forfeited because the government established the property was the proceeds of the illegal activity outlined in the criminal case. The total forfeiture in the matter is valued at approximately $6 million.
"The defendant's conduct in this case was motivated by greed. Bottomley utilized the grey market and sold potentially dangerous unapproved and misbranded pharmaceuticals at discounted prices to American physicians all for a healthy profit. Today's prosecution and the sizeable forfeiture taken in the related civil case demonstrates that the safety and health of the American public is paramount to the U.S. Attorney's Office," U.S. Attorney for the District of Montana Michael W. Cotter.
Bottomley faces possible penalties of three years in prison, a $250,000 fine and one year supervised release.
The investigation was conducted by the Food and Drug Administration, Office of Criminal Investigations.