An unnamed whistleblower has filed a lawsuit against biotechnology company, Amgen Inc., claiming, said Dow Jones, that the drug maker illegally marketed Enbrel and Aranesp.
Wyeth, co-marketer of Enbrel was named as a defendant, as was AmerisourceBergen Corporation, a wholesale drug distributor, and WebMD Health Corporation, an Internet health information source, among others, said Dow Jones.
Enbrel is a rheumatoid arthritis and psoriasis medication and Aransepâ€”which has been found to increase cardiac problemsâ€”is prescribed for the treatment of anemia.
This is not the first time in recent days that whistleblower suitsâ€”known legally as qui tam suitsâ€”filed against drug makers for illegal marketing have made headlines. Most recently, The United States Justice Department (DOJ) joined in two whistleblower lawsuits against drug maker Scios Inc. and Johnson & Johnson Inc. (J&J); J&J is Sciosâ€™ parent company. In that case, the lawsuit alleged the drug makers marketed cardiac drug Natrecor for a use not approved by the U.S. Food and Drug Administration (FDA).
Physicians are permitted to prescribe medications off-label; however, off-label marketing is illegal. Medicare does not cover drugs used for off-label uses unless such off-label use is established to be medically necessary. The DOJ explained in an earlier release, that under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approval, the FDA must determine a drugâ€™s safety and efficacy and, once approved, the drug company may not market or promote the drug off-label.
A revised version of the Amgen suitâ€”which was filed on behalf of the U.S. and some statesâ€”was filed in 2007, but remained sealed to protect the whistleblower under federal law, said Dow Jones; often, qui tams are filed by former employees. Dow Jones reported that the lawsuit alleges that:
The drug makers violated federal and state false-claim laws, Medicare and Medicaid anti-kickback laws, and the U.S. Food, Drug and
Cosmetic Act “by engaging in numerous unlawful activities in their marketing of Aranesp and/or Enbrel”;
Amgen â€œimproperly marketed the attractive economics of Aranesp to customersâ€;
Amgen provided price discounts to customers, hiding such discounts from government health programs, such as Medicare and Medicaid;
Aranesp and Enbrel were marketed off-label for uses not approved by the FDA;
Some off-label marketing occurred on Medscape, a WebMD-owned Internet site; and
Amgen intentionally took these steps to beat out its rival drug, Procrit.
Procrit is marketed by Johnson & Johnson and is the same as Amgenâ€™s Epogen, said Dow Jones, which noted that J&J markets Procrit under a license arrangement with Amgen. Last year, Amgen agreed to pay $200 million to J&J to settle allegations it violated antitrust laws. Amgen was accused of offering discounts to cancer clinics that would use Aranesp and other Amgen drugs. Meanwhile, another whistleblower suit was filed against J&J in 2003 by former sales representatives and claimed J&J offered kickbacks to health-care providers and encouraged off-label Procrit use.
Qui tams allow for private persons to file whistleblower suits to provide the government information about wrongdoing. If it is found a person has submitted or caused others to submit false or fraudulent claims to the U.S.â€”such as federal health care programs and Medicareâ€”the government can recover treble damages and $5,500 to $11,000 for every false or fraudulent claim filed. Whistleblowers can receive 15-to-25 percent of damages awarded.