Pharma 101 - Pharmaceutical Fraud

Archive for October, 2006

InterMune Pays Nearly $37 Million to Settle Claims for Off Label Marketing

InterMune Inc., a Brisbane, California, biopharmaceutical company, has agreed to pay the government $36.9 million to resolve criminal charges and civil liabilities in connection with allegations of illegally promoting Actimmune for treatment of idiopathic pulmonary fibrosis (IPF) or lung scarring despite not receiving approval for such treatment by the U.S. Food and Drug Administration. This settlement resolves allegations that InterMune caused the submission of false claims for Actimmune that were not eligible for reimbursement because they were for unnecessary or off label uses. The FDA had approved Actimmune for treating immune system disorders.

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Medco Pays Government $155 Million for False Claims

Allegedly Tainted Blood Claims and Generous Medical Directorship result in 5.7 Million Dollar Settlement

Northside Hospital located in Atlanta, Georgia, has agreed to pay $5.7 million to settle a whistleblower lawsuit alleging tainted claims were submitted to Medicare because they were the result of improper financial and referral relationships in violation of the Stark law. Two former employees of the Blood and Marrow Transplant Group of Georgia (BMTGA) filed a false claims act lawsuit;  BMTGA, in affiliation with Northside Hospital, also operated a clinical transplant program for stem cell transplants and cancer treatment.  The transplant physicians who own the transplant group also own Atlanta Blood Services, a clinical lab that provided services and blood products to Northside Hospital.

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Unapproved devices hit the FDA Radar Screen

The FDA recently announced that it had filed for a permanent injunction against Endotec Inc. of Orlando, Florida to stop the illegal distribution of unapproved total joint replacement devices. The lawsuit alleges that the company has carried out the illegal distribution of the devices since March 15, 2002, despite the FDA’s warnings that these actions were illegal. This enforcement activity follows increased FDA awareness and resolve to take action against manufacturers of marketed unapproved new drugs. In 2003, after several decades without any apparent real enforcement, the FDA issued a Draft Compliance Policy Guide concerning marketed (but) unapproved drugs, declaring again that the drugs are illegal and that the FDA would exercise its enforcement discretion. There are hundreds if not several thousand prescription drugs on the market which have never obtained FDA approval in any form, yet year after year are unknowingly prescribed by physicians and taken by patients. Fortunately, the FDA in recent years has stepped up its enforcement efforts, even this month taking action against a manufacturer of unapproved dental drugs.