In the second off-label marketing settlement this week, two Johnson & Johnson subsidiaries have agreed to pay $81 million to wrap up a probe of their Topamax promotions. The deal involves a $6.1 million criminal fine for Ortho-McNeil Pharmaceutical, stemming form a single misdemeanor violation, NPR reports.
The settlement stems from whistleblower lawsuits that alleged J&J had promoted Topamax--approved for treatment of epilepsy and migraine prevention--for a variety of psychiatric uses. According to the government, Ortho-McNeil paid doctors to come with sales reps on detailing calls and suggest unapproved uses for the drug. Doctors also were allegedly hired to speak at meetings and dinners about off-label Topamax use.
There has been a string of off-label marketing settlements over the last couple of years. Given the huge size of some of them--think Eli Lilly's $1.4 billion Zyprexa settlement or Pfizer's $2 billion-plus Bextra deal--this $81 million payment seems fairly small. But it does emphasize the government's drive to combat off-label marketing, and there's no sign that drive will end any time soon.
"Working with our federal and state partners, we will take action against pharmaceutical companies that promote their drugs for off-label uses," Assistant AG Tony West promises in a statement. "This type of unlawful marketing undermines the FDA's important role in deciding which drugs are safe and effective for consumers and costs the taxpayers billions of dollars each year."
- get the release from the Justice Department
- see the NPR article
- read the Reuters news