The U.S. Department of Health and Human Services (HHS) is investigating the sales and promotional practices of Endo Pharmaceuticals with regard to their Lidoderm product. HHS is requesting documents dating back to 1999 that might shed light on the issue. Apparently at the heart of the matter is Endo’s alleged marketing of Lidoderm for off-label uses, a practice that is illegal in the United States.
HHS wants to determine what knowledge the company had internally of inappropriate off-label prescription practices. Although marketing of drugs for non-approved usage is not allowed, doctors still have the freedom to prescribe the medications for any purpose as they see fit.
Lidoderm is a topical analgesic patch that was approved by the U.S. Food and Drug Administration in 1999 as a treatment for patients recovering from shingles. Shingles patients often suffer from post-herpetic neuralgia, a painful condition caused by nerve damage.
In a statement, Peter A. Lankau, Endo’s president and CEO, said, “Endo has been and will continue to be firmly committed to promoting Lidoderm and all of Endo’s marketed products responsibly and appropriately within their currently approved indications. We have a strong ethics and compliance program. To that end, we routinely conduct extensive training for our employees to reinforce the importance of promotional practices that are within the FDA-approved indication.â€
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