Amgen Target of Whistleblower Lawsuit

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 Aransep—which has been found to increase cardiac problems—is prescribed for the treatment of anemia.

This is not the first time in recent days that whistleblower suits—known legally as qui tam suits—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 Scios’ 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 drug’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 suit—which was filed on behalf of the U.S. and some states—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 “improperly marketed the attractive economics of Aranesp to customers”;
    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 Amgen’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.—such as federal health care programs and Medicare—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.

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