In its latest quarterly earnings report filed with the U.S. Securities and Exchange Commission last week, Johnson and Johnson disclosed that the company is under federal investigation for marketing practices related to two products — a drug and a medical device.
The filing notes that Janssen Pharmaceuticals, a J&J company, received a letter in March from the U.S. Department of Justice requesting certain documents related to how the drug Doribax is marketed and promoted. Doribax is an antibiotic that is already approved to treat abdominal and urinary infections. It has recently been in the news because Johnson & Johnson halted a clinical trial early when more pneumonia patients who were given Doribax died instead of recovered.
The second investigation involves a medical device. In the regulatory filing, J&J discloses that Acclarent, which it bought in 2009, received a federal subpoena from the Massachusetts U.S. Attorney’s Office in May related to the marketing of Relieva Stratus MicroFlow Spacer and related products to treat sinus problems.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
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In late December, Johnson & Johnson agreed to pay $1 billion to the DOJ to settle charges that it engaged in the off-label promotion of the drug Risperdal.
A Johnson and Johnson spokesman declined to comment.
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