Whistleblower case relating to cancer prescriptions
US biotech firm Celgene has agreed to pay $280 million (£211 million) to settle a lawsuit over the company promoting its drugs Thalomid and Revlimid for off-label uses.
The US Food and Drug Administration (FDA) originally approved Thalomid (thalidomide) and Revlimid (lenalidomide) to treat erythema nodosum leprosum (a side effect of leprosy) and myelodysplastic syndromes (a group of bone marrow disorders), respectively. The case alleges that Celgene aggressively marketed Thalomid and Revlimid as treatments for a wide range of cancers even though, at the time, the FDA had only approved them for very rare conditions. Thalomid was Celgene’s leading product in 2005 with sales over $100 million. US doctors can prescribe medicines for other conditions, but it is illegal for companies to promote drugs to treat those not approved by the FDA. The FDA warned Celgene against marketing the drug to treat cancer in 1998 and 2000.
Both drugs are now approved as multiple myeloma treatments and Revlimid as a lymphoma treatment.
Beverly Brown, a former Celgene sales manager, filed the lawsuit under the US False Claims Act, which encourages whistleblowers to report wrongdoing by rewarding them with a share of any payout.
The company said in a statement that this settlement does not represent an admission of wrongdoing.