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.

Quality Control Violation Reports Prompt Drug Maker Mylan to Halt Production, Launch Probe

by Nolan and Auerbach on July 28, 2009

While Mylan has not publically acknowledged serious problems at its generic drug manufacturing facility, the Pittsburgh Post-Gazette has obtained internal reports alleging that employees at the Morgantown, W. Va. plant have violated government-mandated quality control procedures. According to the Post-Gazette, “… workers were routinely overriding computer-generated warnings about potential problems with medications… .”

Current Good Manufacturing Violations may render pharmaceuticals to be adulterated and may also be the basis of False Claims Act violations. In particular, falsification in CGMP record-keeping may be false records or statements that cause false claims for such adulterated pharmaceuticals to be submitted to Government payors.

Mylan is the world’s third largest generic drug company and the plant in Morgantown produces about 19 billion doses of medicine each year to treat diabetes, hypertension, depression, cancer, epilepsy and other conditions, according to the article.

It is unclear whether the multiple and serious FDA violations in the report resulted in tainted medications.

For the full article, go to: http://www.post-gazette.com/pg/09207/986516-28.stm.

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

Tagged as: , , , , ,

Leave a Comment

Previous post:

Next post: