on the  $1.1billion included in the recovery Act for comparative effectiveness research.  The funds requested will continue efforts to produce state-of-the-science information on what medical treatments work best for a given condition.

Not only will these  findings enhance medical decision-making by patients and their physicians,  they will likely  close the door a little bit more to the success of off-label marketing of pharmaceuticals for indications that have little to no science to back up the claims of efficacy. Physicians will hopefully have a readily available source from which to compare treatments and drugs.

West Virginia is asking $2 billion under the state’s Consumer Credit and Protection Act, related to the drug company’s dissemination of an alleged inadequate label on its Zyprexa antipsychotic product. The lawsuit claims that Eli Lilly should be punished for disseminating the inadequate label.

Eli Lilly claims West Virginia is overstepping its bounds and into those of the FDA.

According to the article, the motion also says that penalizing Eli Lilly $5,000 for each Zyprexa prescription distributed from Feb. 28, 2002-Oct. 2007 (which is about 400,000 with the alleged improper labeling) would “lead to a grossly disproportionate punishment” under the U.S. Constitution.
In January, Eli Lilly agreed to pay $1.4 billion to settle federal civil and criminal claims. The payment also benefited the Medicaid programs of more than 30 states that collectively received approximately $362 million, according to the article on LegalNewsline.com.

To read the article in its entirety, go to: http://www.legalnewsline.com/news/221408-eli-lilly-w.vas-claim-for-civil-penalties-inappropriate-greedy.

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

In the letter, addressed to Frank M. Torti, MD, MPH, Grassley writes: “While I appreciate the fact that some information, including certain business trade secrets, needs to be protected from unauthorized disclosures, I have serious concerns that your memorandum goes beyond legitimate privacy concerns and appears to run contrary to many statutes protecting executive branch communications with members of Congress.

Specifically, your memorandum notes that certain information acquired from businesses and industry is protected as confidential and may only be disclosed in limited circumstances. Your memorandum cited the Food, Drug, and Cosmetic Act, the Freedom of Information Act (FOIA), the Trade Secrets Act, and the Privacy Act, as well as FDA regulations as the controlling authority for determining when a document or information may be disclosed. You added that FDA employees who violate these provisions may face disciplinary sanctions and criminal liability.”

Grassley’s concern is that FDA employees should have the right to talk to Congress and to provide Congress with information free and clear of FDA agency influence. Further, these employees have the right to be free from fear of retaliation or reprisal, he writes.

For the letter in its entirety, go to http://www.iowapolitics.com/index.iml?Article=153174. For more information about qui tam law and health care fraud, including pharmaceutical fraud, contact Nolan and Auerbach, PA.

The government agency issued warnings to Ranbaxy late last year for more than 30 of the pharma giant’s generic drugs, produced at two plants in India. According to Inside Washington Publishers’ October 10, 2008 FDA Week, FDA sued Ranbaxy last summer, stating that the company was likely selling adulterated drugs in the U.S.

But FDA may have dropped the ball–some say, knowingly. FDA Week reports that FDA did not begin blocking Ranbaxy imports until September, even though the agency knew about the problems as early as 2005.

The Department of Justice is investigating claims that Ranbaxy produced HIV medication that contained insufficient active ingredients or was adulterated with other ingredients.

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.

To read the complete article; to read more about pharmaceutical fraud.

One area of charges involves clinical trial fraud. According to the indictment, Palazzo, as a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline, fraudulently failed to maintain and prepare records required by the FDA for evaluation the drug’s safety and effectiveness in children and adolescents.

During approximately a five-year period, Palazzo also defrauded Medicare in connection with services she claimed to have rendered to patients in a Psychiatric Partial Hospitalization Program at Touro Infirmary , according to the indictment.

The indictment also charges that Palazzo defrauded Medicare by submitting fraudulent invoices to Touro for consulting and medical director services. The indictment says because of that Medicare paid Palazzo over $653,000 she was not entitled to receive. (Consulting and Medical director costs of hospitals are passed on to Medicare in part, under the cost report system).

See the full story here.

To read more click here or more about pharmaceutical fraud at Nolan & Auerbach.

To read more click here. To learn more about drug company inducements as a violation of the False Claims Act, click here.

The postmarketing study was carried out between November 2001 and March 2002 on behalf of Aventis by PPD, after the FDA required more safety information on Ketek following concerns that it could cause liver problems.

The study was allegedly riddled with fraud, including unscrupulous patient recruitment by some of the enrolling doctors and significant under reporting of adverse events.

To read more about CRO fraud and how it can result in a violation of the False Claims Act, click here.