When counterfeit Avastin was discovered in the U.S. last year, it raised the stakes in the FDA and law enforcement efforts to keep the drug supply chain clear of fakes. The FDA launched an all-out effort to pursue the case and in April said it had nailed one of the key players in the process and wanted to make an example of him with federal jail time. But a judge in Montana saw it differently and has sentenced him to house arrest instead.
Paul Daniel Bottomley also gave up $4.5 million in cash and property and will serve 5 years of probation once his 6 months of house arrest are over, according to the NBC affiliate in Missoula. Prosecutors had asked that the 48-year-old Bottomley be sentenced to a year in federal prison, but his lawyers asked for the lighter sentence, noting that he had cooperated with investigators.
In February 2012, the FDA and Avastin maker Roche ($RHHBY) notified doctors that what they believed were vials of the cancer drug were a counterfeit that contained starch and salt but no active ingredient. An offshore company owned by Winnipeg-based Canada Drugs acknowledged the business had shipped the drugs but said it was unaware they were fake.
The FDA has said the drugs were sold through Montana Health Care Solutions, a company the AP reports that Bottomley created in 2008 and sold to Canada Drugs in 2010 for $5 million. He was kept on as an adviser and paid $10,000 a month. The drugs were sold to physician practices in the U.S. at a discount to what they would have paid if they had bought them through the legitimate supply chain.
The FDA has also pursued cases against physician groups it says knew they were buying misbranded drugs, although they didn't realize the products were fakes. In December, a doctors' practice in Knoxville, TN, pleaded guilty to buying a number of foreign-made drugs from firms associated with Canada Drugs. Just last week, a California doctor group pleaded guilty to similar charges.
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