The U.S. Food and Drug Administration (FDA) recently announced that a Montana resident who served as a consultant to a company that imported counterfeit cancer drugs was sentenced following his guilty plea to misprision of a felony. According to a Department of Justice press release, a federal court has sentenced Paul Bottomley to five years of probation with six months of home confinement, civil forfeiture of $4.4 million and 200 hours of community service.
The FDA apparently alleged that Bottomley owned Montana Health Care Solutions (MHCS), which opened in 2008 and was sold in 2010 to Rockley Ventures, Ltd. MHCS allegedly distributed drugs from foreign countries to American physicians with labels that did not conform to FDA-approved labeling for U.S. versions of the drugs. After MHCS was sold, Bottomely remained as a paid advisor and made sales calls to physicians on behalf of the company which allegedly imported and sold counterfeit oncology drugs that did not contain the active drug ingredients in legitimate versions. The charge to which Bottomley entered a plea would have required FDA to prove that he knew about the alleged felony, failed to notify authorities and concealed the crime.
According to an FDA blog post about the sentencing, Bottomley “acted out of greed,” selling potentially dangerous unapproved and misbranded pharmaceuticals at discounted prices to American physicians solely for profit. See U.S. Department of Justice Press Release, July 12, 2013; FDA Voice, July 15, 2013.