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.

CRO’s Conflict of Interest

by Nolan and Auerbach on July 2, 2007

St. Petersburg Reporter Chris Hundley wrote (July 1, 2007)  a well-written, balanced and comprehensive (as can get in an article) about Contract Research Organizations (CRO’s).  The article points out the inherent conflict of interest for CRO’s to manage clinical trials pre-approval (for NDA submission) and at the same time substantially invest  in the pharmaceutical company that is the owner of the drug in trials. Although  the FDA is quoted as not seeing the conflict of interest as a problem, and indicating that only 1-2% of inspections of clinical trials uncover fraud, it seems unlikely that the FDA is out looking for such fraud, or has enough resources to police the issue adequately.

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

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