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.

FDA Warns Pfizer About Pediatric Trials of Geodon

by Nolan and Auerbach on April 26, 2010

On April 9th, the FDA issued a Warning Letter to Pfizer, Inc. concerning its conduct during a clinical trial for one of its prescription drugs on the market. According to a Wall Street journal article (“FDA Warns Pfizer About Pediatric Trials of Geodon,” April 21, 2010) the drug (name redacted in the Warning Letter) is Geodon, which is FDA-approved to treat schizophrenia and bipolar disorder in adults. The FDA admonished Pfizer over its failure to properly monitor the clinical trials resulting in excessive doses given to pediatric subjects. The Warning Letter reads “dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.” Geodon does not have a pediatric indication.

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

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