Earlier this week, we mentioned the latest drugmaker-U.S. government settlement of marketing claims: Novartis' promise to pay an $185 million fine to wrap up a criminal investigation into its promotion of the epilepsy med Trileptal, and to plead guilty to violating the U.S. Food, Drug, and Cosmetic Act. It marked the latest in a string of similar--albeit larger--settlements involving the likes of Eli Lilly, AstraZeneca and Pfizer.
As the Wall Street Journal reports today, this settlement--and Novartis' ongoing negotiations to resolve civil claims relating to Trileptal, plus potential off-label marketing claims related to five other drugs--shows the U.S. Justice Department is on the drug-marketing warpath.
Just this month, Justice charged Johnson & Johnson with paying kickbacks to incentivize a nursing home pharmacy firm to increase sales of J&J drugs. (J&J says it acted legally and appropriately.) The government has also been focusing on off-label marketing, and on gifts or payments to doctors designed to ratchet up prescriptions of certain drugs. And because of that focus, drugmakers have been more wary--and perhaps more careful, as PhRMA chair and AstraZeneca chief David Brennan has said.
But some legal experts say they're still not careful enough. A former Justice lawyer who now represents whistleblowers said these big settlements aren't deterrent enough. "It's not going to stop until the government puts some of these executives in jail," Shelley Slade of Vogel, Slade & Goldstein tells the Journal. "Many of these companies view the fines as a small fraction of what they have gained through illegal schemes, and just a cost of doing business."
- read the WSJ story