Endo Health fined $192.7 mn over improper marketing of shingles drug Lidoderm

US-based diversified healthcare company Endo Health Solutions and its subsidiary Endo Pharmaceuticals have agreed to pay $192.7 million to settle US criminal and civil liability for improperly marketing its shingles treatment Lidoderm for unapproved uses.

Under the terms of the plea deal, Pennsylvania-based Endo Health will pay $171.9 million to resolve civil false claims of ''off-label marketing'' and a criminal fine of $20.8 million.

US regulators charged that, between 2002 and 2006, Lidoderm was approved by the Food and Drug Administration (FDA) only for treating pain associated with post-herpetic neuralgia (PHN), a complication of shingles.  

But during this period, Endo Pharmaceuticals misbranded and marketed the treatment for uses other than treating PHN related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome.

The FDA said that once approved, a drug may not be sold for unapproved or ''off-label'' uses until the company receives regulatory approval for new intended uses.  

The regulator alleges that certain Endo Pharmaceuticals sales managers provided instruction to certain sales representatives concerning how to expand sales conversations with doctors beyond PHN and encouraged promotion of Lidoderm in workers' compensation clinics.

''The safety and efficacy of drugs must be shown by science, not sales pitches,'' said US Attorney for the Northern District of New York Richard Hartunian. ''This settlement emphasises that public health is protected by labeling based on product performance, rather than profitability, and promotes enhanced efforts to ensure compliance with all requirements.'' 

Endo Health was created in 1997 through a successful management buyout of Endo Laboratories's generic products along with 12 important brands from the Merck and DuPont joint venture, DuPont Merck Pharmaceutical Company.

Its branded segment offers Lidoderm, Opana ER, Opana, Percocet, Voltaren Gel, Frova, Supprelin, Vantas, Valstar, and Fortesta Gel products in pain management, urology, endocrinology, and oncology areas, while its generics division provides non-branded generic products in the pain management, urology, central nervous system disorders, oncology, immunosuppression, women's health, and hypertension markets.

The company has a market cap of $9 billion and posted net loss of $ $740 million in 2013 on revenues of $3 billion.