Pharmaceutical Kickbacks

Right now the pharmaceutical industry is in the middle of its biggest challenge in history. Whistleblowers have exposed and continue to expose fraudulent practices ranging from pricing issues to sales and marketing practices at a rate never anticipated by either the pharmaceutical industry or the Department of Justice. Settlements and jury verdicts have been headline grabbing and large, attracting the attention of pharma, regulators, Congress and taxpayers. The qui tam pharmaceutical fraud cases settled since 2000 alone have amounted to over 3.5 billion dollars, representing various patterns of fraud. We expect to see some new patterns as time goes by, especially with the new Medicare prescription drug benefit. Pharmaceutical fraud is still abundant and this blog is intended to keep readers up to date with all pharmaceutical fraud related news and to provide commentary when warranted. This blog also contains an array of laws and regulations concerning the Federal Food, Drug and Cosmetic Act set out in an easy to read format.

Aventis Aware of Fraudulent Data Regarding Ketek Says CRO Employee

by Nolan and Auerbach on February 22, 2007

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.

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