Pharma 101 - Pharmaceutical Fraud » off label drug use

AstraZeneca Agrees to $520 Million Settlement

Nolan and Auerbach — Wed, 28 Apr 2010 18:27:54 +0000

Attorney General Eric Holder announced April 27, 2010, that AstraZeneca has agreed to pay $520 million to federal and state taxpayers to settle claims that it illegally marketed the anti-psychotic drug Seroquel for uses that were not approved as safe and effective by the Food and Drug Administration. As part of this scheme, AstraZeneca was accused of illegally promoting Seroquel to physicians off label and in violation of the federal Anti-Kickback statute, all in furtherance of supporting the drug’s use for a host of illnesses for which it was never approved, according to the U.S. Department of Justice. This pharmaceutical fraud settlement is the largest amount ever paid by a company in a civil- only settlement of off-label marketing claims. The federal government will receive $302 million, and states will share up to $218 million.

For the full announcement, go to: http://www.justice.gov/ag/speeches/2010/ag-speech-100427.html.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Eli Lilly Pays Record Fine for Off-Label Drug Marketing

Nolan and Auerbach — Mon, 19 Jan 2009 20:22:57 +0000

Philadelphia, Pennsylvania— Multiple news publications have confirmed that Eli Lilly & Co. will, in the largest United States-imposed criminal fine on an individual company, pay $1.42 billion for the off-label marketing of its drug Zyprexa. This record-breaking false claims case settlement was announced on January 16 by Acting U.S. Attorney Laurie Magid and Attorney General Michael Mukasey. Lilly will reportedly make its guilty plea in the U.S. District Court of Philadelphia within the next few weeks.

The 10th largest pharmaceutical company in the world, Eli Lilly & Co. admitted to off-label use of Zyprexa; specifically, the organization promoted the drug for dementia in elderly populations, a usage that was not approved by the Food and Drug Administration. Additionally, Lilly trained its sales force to disregard the law by promoting Zyprexa for off-label uses. Thus over a period of two years (September 1999-March 2001), Lilly earned “hundreds of millions of dollars” through consistent criminal violations of the Food, Drug, and Cosmetic Act.

Of the civil settlement, $438 million will go to the federal government and up to $362 million will be allocated to states included in the settlement. As a component of its restitution, Lilly will undergo five years of U.S. monitoring against future lawbreaking. Independent from the current settlement, the company also faces lawsuits across twelve states for improper and off-label drug marketing.

This monumental case was initiated by Lilly sales representatives who in 2003 filed complaints against Lilly under the terms of the federal False Claims Act. For their actions, the whistleblowers will receive over $78 million— or 18 percent of the settlement— in addition to possible shares of state settlements.

To learn more go here. or if you have information about Pharmaceutical Fraud contact Nolan & Auerbach P.A.

Unapproved devices hit the FDA Radar Screen

Nolan and Auerbach — Fri, 13 Oct 2006 17:14:38 +0000

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.