Pharma 101 - Pharmaceutical Fraud

Archive for March, 2008

Big Pharma Pays $13.6 million for Price Inflation

U.S. District Court Judge Patti Saris has ordered drug companies AstraZeneca and Bristol-Myers Squib to pay a total of $13.6 million in a Masachusetts case that alleged that they inflated the average wholesale price (AWP) of expensive and in some cases, life-saving drugs.  Judge Saris also found that the companies “unfairly and deceptively caused to be published false” average wholesale prices of drugs and thus caused “real injuries to the insurers and the patients who were paying grossly inflated prices for critically important, often life-sustaining drugs.”  Judge Saris said that she decided to double the assessed damages because the conduct was willful on the part of the companies. Judge Saris further stated that “The Defendants well understood the devastating impact the mega-spreads had on old and sick patients required to make co-payments they could ill afford.”  

Bristol-Myers is maintaining that their pricing was fair and that they intend to appeal this decision. 

Of note is the fact that Judge Saris remarked and doubled the damages due to the wilfulness on the part of the defendants.  Further, this can expand to a nationwide class action lawsuit.   

To read more click on:  http://www.boston.com/news/local/massachusetts/articles/2007/11/02/drugs_companies_ordered_to_pay_136_million_for_inflating_prices/  or to read more about pharmaceutical fraud go to www.whistleblowerfirm.com/pharmaceuticalfraud 

  or to read more about go to  

FDA Issues a draft Guidance for Dissemination of Information on Unapproved Uses of Medical Products

The U.S. Food and Drug Administration (FDA) last Friday issued a draft guidance on “Good Reprint Practices” for regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. Draft guidances are often put into final form with substantially the same wording.

“Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care,” said Randall Lutter, FDA deputy commissioner for policy. “This guidance also safeguards against off-label promotion.”

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an “off-label” use. However, Section 401 expired on Sept. 30, 2006.

The FDA’s “Good Reprint Practices” draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications.

Publications that the medical community rely on should be independent. Accordingly, some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.

Not surprisingly, the draft guidance also recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article, and further, (stating the obvious), that articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed.