A Belgrade man has admitted to federal charges that he knew about the illegal importation and distribution of cancer drugs and failed to report the activity.
During an appearance Wednesday before U.S. Magistrate Judge Jeremiah Lynch in Missoula, Paul Daniel Bottomley, 48, pleaded guilty to misprision of a felony in a plea agreement reached with the U.S. Attorney’s Office.
Bottomley already has forfeited to the government 10 parcels of land in Gallatin County, $1.08 million and a 2011 Aston Martin sports car in a civil action related to the case. The Aston Martin Vantage V-12 sold for $110,000 at a U.S. Marshals Service auction in Billings earlier this month.
Lynch set sentencing for July 31 and continued Bottomley’s release. Bottomley faces a maximum of three years in prison and a possible $250,000 fine. The government said it will not seek a fine because of the forfeiture.
Bottomley was president of Montana Healthcare Solutions, a Belgrade-based company that prosecutors said illegally imported and sold cancer medications to doctors at prices lower than the cost of Food and Drug Administration-approved medication.
Assistant U.S. Attorney Jessica Fehr said in court records that an FDA investigation that began in April 2010 learned that Bottomley's company was importing misbranded and unapproved cancer drugs from foreign countries and selling the drugs to doctors in the U.S.
The drugs required FDA approval before they could be imported, Fehr said. The foreign drugs that Bottomley distributed were not typically the versions approved by the FDA for use in the United States, and the labeling information did not conform to FDA’s requirements for the U.S. versions, she said.
In October 2010, Bottomley sold his company to Canada Drugs Ltd., an Internet-based pharmacy company in Winnipeg, Manitoba, for $5 million through a subsidiary of Canada Drugs, called Rockley Ventures.
Bottomley continued to advise Rockley Ventures, Canada Drugs and other related companies and was paid $10,000 a month for his services, Fehr said.
Beginning in January 2012, she said, FDA investigators learned that a counterfeit version of the prescription cancer drug Avastin was being imported and that Montana Healthcare Solutions was distributing it and charging less than what Avastin would normally cost in the U.S., Fehr said. The FDA issued a warning to health care professionals about the counterfeit Avastin.
Some doctors admitted to investigators that they knew the drugs were foreign and unapproved versions of U.S. drugs but still billed insurance companies the prices they would bill for U.S. drugs, Fehr said.
At the time the counterfeit Avastin was being imported, Montana Healthcare Solutions was a subsidiary of Canada Drugs and Rockley Ventures. Although Bottomley was not involved with the importation and distribution of counterfeit Avastin, he became aware of the activity and did not notify authorities, Fehr said.
In January, FDA said its Office of Criminal Investigations had more than 200 investigations nationwide into schemes in which medical practices buy foreign, unapproved drugs and dispense them to “unsuspecting patients for personal gain.”
Some of the investigations have led to criminal convictions of doctors and distributors around the country.