|Adderall--Courtesy of CVS|
Shire ($SHPG) and the U.S. Justice Department have come to terms: The Ireland-based drugmaker agreed to pay $56.5 million to settle a variety of alleged marketing violations. So far, so familiar, given the long list of pharma companies that wrapped up similar investigations.
What's different here is that the settlement actually appears to be friendly. "Shire cooperated throughout this investigation and, in advance of this settlement, began to correct its marketing activities," U.S. Attorney Zane David Memeger said in a statement.
When it comes to marketing settlements, $56.5 million is pocket change. Even with an additional $2.9 million for Louisiana, which claimed Shire broke state law, that's less than $60 million. One reason: It doesn't include a fine, civil or otherwise.
True, the allegations don't involve kickbacks--so often a part of Big Pharma whistleblower claims--and the alleged off-label marketing was limited; Shire allegedly promoted Adderall XR to treat conduct disorder, an unapproved use. And it said its colitis drug Lialda could be used to prevent colorectal cancer.
Most of the shenanigans involve exaggeration and overselling. For instance, the company's reps allegedly claimed that the ADHD drug Vyvanse was "less abusable" than its rival amphetamine-based ADHD meds. Same for Daytrana, its ADHD patch.
They allegedly touted Adderall XR as superior to rivals on the efficacy side, saying that it was so effective, it would make ADHD folks "indistinguishable" from non-ADHD peers, the DOJ said.
And then there were some laughable sales points: Shire allegedly said Adderall would prevent job loss, poor academic performance, traffic accidents, sexually transmitted disease and criminal behavior. Vyvanse would prevent car accidents, divorce, arrests and unemployment, the Justice Department said.
All in all, not so egregious when compared with marketing antipsychotics for unapproved use in kids, or to treat dementia patients when studies had shown the drugs could be dangerous for them. Here's an idea, though. In other settlement announcements, prosecutors have scolded drugmakers for repeat violations. They've attributed record-setting criminal fines to what they considered a flouting of the marketing rules. Shire, by contrast, apparently played nice with the Justice Department investigators. Big Pharma might want to take note.
- read the DOJ release
Special Reports: Pharma's top 11 marketing settlements