Pharma 101 - Pharmaceutical Fraud

FDA Launches Draft Guidelines On Financial Ties With Drug Companies

Aventis Aware of Fraudulent Data Regarding Ketek Says CRO Employee

A former staff member of the Pharmaceutical Product Development (PPD) has claimed that Aventis and PPD - the contract research organization (CRO) hired by Aventis- both knew of fraudulent data in a postmarketing trial for the antibiotic drug during a testimony before a US Congressional subcommittee last week.

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.

Is Big Pharma Manufacturer Roxane Overcharging the Government?

The United States Attorney’s Office announced on January 29, 2007, in Boston, Massachusetts that it is intervening in a whistleblower lawsuit filed against Boehringer Ingelheim Roxane, Inc. (”Roxane”) The allegations center around the contention that Roxane reported inflated prices for numerous pharmaceutical products knowing the federal health care programs would establish reimbursement rates based on these fraudulent prices. According to the Government?s complaint, these reported prices were in excess of 1,000 percent of the actual sales prices on several of the drugs it manufactures. It is alleged that damages to federal programs exceeds $500 million.

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Congress now has the power to shake up the FDA

With the new Democratic-controlled Congress, how the FDA accomplishes enforcement will likely change, which may in turn effect the level of resources devoted to the investigation of qui tam complaint allegations. In June 2006, a government report was issued entitled “Prescription for Harm: The Decline in FDA Enforcement Activity”, as a result of the House Committee on Government Reform having commissioned an investigation to evaluate the FDA enforcement activities related to the pharmaceutical industry under the Bush administration. The Report did not present a well-oiled enforcement machine.

To see the full report, click here.

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Pharma Group Says “No” To Expensive Gifts to Doctors Which Could Influence Their Drug Choices

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), a worldwide trade group said that under their revised ethics code that as of January 1, 2007, they were no longer permitted to provide expensive gifts to doctors. This change to the ethics code was the first in the past 10 years. Members of this trade group are no longer permitted to give physicians money or expensive gifts such as stays in luxury hotels or trips to golf resorts that might influence their prescription drug selections. IFPMA members include Pfizer, GlaxoSmithKline, Sanofi-Aventis, Eli Lilly, AstraZeneca, Merck and Novartis. Here’s to more reform!

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499 Million Bristol-Myers Squibb Agreement to Settle Fraud Charges

The United States Department of Justice has reached a tentative settlement with Bristol-Myers Squibb in the amount of $499 million to settle several investigations involving the Company’s sales and marketing as well as drug pricing activities.

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Pharma Has Its Nose In Clinical Trials

A survey published in the New York Journal of Medicine found that more than a third of experts who oversee clinical trials at both medical schools and research hospitals have financial ties to pharmacutical and/or medical device companies. It was further found that some experts had a direct conflict of interest under federal rules; voting on or discussing clinical trials sponsored by companies they had relationships with or competitors of those very same companies. These experts may be part of review boards who are supposed to be insuring the scientific validity of clinical trials and safeguarding the safety of patient participants. Susan L. Rose, executive director of University of Southern California’s Office for the Protection of Research Subjects, said academic institutions had been reassessing their policies and discussing the need for mandatory disclosures. To read more click here:

Omnicare Really Did Not Care….A Cool $49.5 Million Settles Omnicare Drug Provider Case

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