Fremont, Calif.-based Scios, a subsidiary of Johnson & Johnson, has pleaded guilty to misbranding its heart failure drug Natrecor and will pay an $85 million criminal fine, according to a news release from the Department of Justice.
Scios admitted that it intended the drug be used for purposes not approved by the FDA. The company admitted that the FDA-approved labeling for the drug did not contain any directions for scheduled, serial use to treat chronic, non-acute congestive heart failure patients — which is how Scios intended the drug be used.
Read more at Becker’s ASC Review.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
