There is one other recent example: Purdue Pharma's parent pled guilty to illegal marketing of its OxyContin painkiller, and three current or former execs admitted to wrongdoing last May, although they avoided jail time. So is the government starting to use a select few cases, such as InterMune, to send a message to other pharma and biotech execs?
Speaking generally, Judith Waltz, a partner at Foley & Lardner, says that given the rarity with which the government goes after execs for illegal off-label marketing, conduct would probably have been judged by prosecutors to be particularly egregious for charges to be pursued. Waltz represents individual pharma execs, she discloses, but none involved in the InterMune prosecution. "The government may be trying to make an example," Waltz tells the paper. "That scares the hell out of everybody once they start talking about individuals."
The FDA approved the biotech's Actimune to treat a rare form of osteoporosis. InterMune, however, pitched the stuff to pulmonologists to treat a fatal lung disease which has no cure and affects 83,000 Americans, according to the deferred prosecution agreement. In August 2002, the biotech issued a press release which mischaracterized the results of a clinical trial to make it seem its drug was more effective for the lung disease than it actually was, according to InterMune's agreement with prosecutors, the Recorder writes.
That fall, a specialty pharmacy that distributed Actimune sent patients a letter that regurgitated the same misinformation about the drug. An InterMune employee signed off on that letter. As part of its deal with the government, InterMune paid a $30 million civil settlement and agreed to a corporate monitoring program.