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.

Off-Label Bonanza Detected by Hospital Records

by Nolan and Auerbach on May 26, 2011

Anyone interested in off-label cases should review the retrospective analysis recently published by researchers funded by the Agency for Healthcare Research and Quality. In the study, “Off-Label Use of Recombinant Factor VIIa in U.S. Hospitals: Analysis of Hospital Records,” Aaron C. Logan et al., Ann Intern Med, April 19, 2011, 154:516-522;  investigators examined 12,644 discharge records of patients who received rFVIIa at U.S. hospitals from 2000-2008. Investigators concluded that off-label use of rFVIIa increased more than 140-fold during this time, whereas use for hemophilia increased less than 4-fold. Worse, in 2008, 97% of the in-hospital use of rFVIIa was for off-label indications, including cardiovascular surgery, trauma, and intracranial hemorrhage. This, despite the concern about the application of rFVIIa to conditions that lack strong supporting evidence. As costs for certain biologicals are sometimes baked into the inpatient DRG reimbursement system, this type of off-label use without appropriate supporting evidence can cost taxpayers hundreds of millions, and worse…

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, P.A.

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