Pharma Exec Indicted for Role in Alleged Fraudulent Drug Marketing

Here’s an enticing lead in a story from this morning’s Recorder: “A grand jury indicted . . . . Scott Harkonen, former CEO of the Brisbane, Calif.-based biotech firm InterMune Inc., Tuesday for allegedly fraudulently marketing the company’s drug Actimmune. The decision marks a rare instance in which the Justice Department has gone criminal against an individual executive for off-label marketing abuses, rather than just reaching a deferred-prosecution agreement with the drug company.”

According to the report, the FDA approved Actimmune to treat a rare form of osteoporosis. But prosecutors accuse Harkonen of crafting a 2002 press release falsely claiming the drug could treat a fatal lung disease called idiopathic pulmonary fibrosis. While it’s legal for doctors to prescribe drugs for off-label uses, pharma companies themselves can’t market products for conditions beyond what the FDA has approved.

Harkonen is represented by Morrison & Foerster partner James Brosnahan. San Francisco AUSA Ioana Petrou is the lead prosecutor on the case, supervised by criminal chief Brian Stretch.

“Pharmaceutical executives who promote drugs using false and misleading information should not be allowed to hide behind a corporate shield,” said FDA special agent Kim Rice in a press release. “Pharmaceutical companies do not run themselves, and those who engage in criminal conduct will be held personally accountable.”

Technorati Tags: personal, market

Here’s an enticing lead in a story from this morning’s Recorder: “A grand jury indicted . . . . Scott Harkonen, former CEO of the Brisbane, Calif.-based biotech firm InterMune Inc., Tuesday for allegedly fraudulently marketing the company’s drug Actimmune. The decision marks a rare instance in which the Justice Department has gone criminal against an individual executive for off-label marketing abuses, rather than just reaching a deferred-prosecution agreement with the drug company.”

According to the report, the FDA approved Actimmune to treat a rare form of osteoporosis. But prosecutors accuse Harkonen of crafting a 2002 press release falsely claiming the drug could treat a fatal lung disease called idiopathic pulmonary fibrosis. While it’s legal for doctors to prescribe drugs for off-label uses, pharma companies themselves can’t market products for conditions beyond what the FDA has approved.

Harkonen is represented by Morrison & Foerster partner James Brosnahan. San Francisco AUSA Ioana Petrou is the lead prosecutor on the case, supervised by criminal chief Brian Stretch.

“Pharmaceutical executives who promote drugs using false and misleading information should not be allowed to hide behind a corporate shield,” said FDA special agent Kim Rice in a press release. “Pharmaceutical companies do not run themselves, and those who engage in criminal conduct will be held personally accountable.”

Technorati Tags: personal, market