The National Law Journal (12/29, MacLean) reported, "The federal class action accusing Amgen, Inc. and other biotechnology firms of illegally promoting off-label use of drugs in violation of the Racketeer Influenced and Corrupt Organizations Act (RICO) appears to be hanging on by a thread." The suit alleges that "between 2002 and 2007, Amgen, DaVita, Inc. and Fresenius Medical Care Holdings, Inc. marketed two drugs that are used to treat anemia by boosting red blood cell counts for uses other than those approved by the" Food and Drug Administration (FDA). The drugs, Epogen (epoetin alfa) and Aranesp (darbopoetin alfa), are currently "approved for treatment of people with kidney disease and cancer, HIV patents, and those receiving chemotherapy." A US District judge "dismissed the multi-district litigation on Dec. 17," saying that the plaintiffs, "seven health-benefits plans...cannot use federal civil racketeering and state unfair business practices claims for alleged violations that are the sole enforcement province of" FDA regulators. The judge, however, did allow "the plaintiffs to amend their suit to keep it alive."
Cephalon settles off-label marketing suit. The AP (12/29) reported, "Attorney General Jack Conway says Kentucky has received $2.3 million from a Pennsylvania pharmaceutical company to resolve a legal dispute." At issue was whether "drugmaker Cephalon had marketed their products for off-label uses to doctors." Under the settlement, "the company agreed in October to pay a $375 million civil settlement, a $40 million criminal fine, and $10 million in criminal forfeiture." Kentucky was among "several states getting a portion of those funds."
Cephalon also "paid the state of Idaho $171,755" under the agreement, Idaho Business News (12/29) added. The drugs were approved by the Food and Drug Administration "for specific treatments: Provigil (modafinil) for narcolepsy and sleep disorders, Gabitril (tiagabine) for partial treatment of seizures, and Actiq (fentanyl oral transmucosal) to treat cancer patients for whom morphine-based painkillers are no longer effective." But, "the federal government and states claim that Cephalon sales representatives marketed the drugs for" off-label uses, and "some of the unapproved uses promoted by Cephalon were not approved for reimbursement by federal and state Medicaid programs." Consequently, "false and/or fraudulent claims" were submitted, which resulted in "the loss of taxpayer dollars," Idaho Attorney General Lawrence Wasden said.
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