Most of the U.S. Department of Justice’s major pharma-related decisions invoking the False Claims Act recently have involved illegal marketing and sales. So far, GSK’s is the only one to deal with current good manufacturing practices (cGMP’s).
I thought the whole "Rost for FDA Chief" that surfaced after John Mack's recent poll was a joke, but then read that Dr. Rost, who emerged as the favorite candidate in that poll, has received the backing of at least two members of Congress.
One of the first employee whistleblowing cases to invoke Sarbanes-Oxley (for more, click here) nvolved cGMPs and pharmaceutical industry training. The plaintiff did not win. Today, Lora Bentley at the IT-Business Edge blog published an article discussing why employees invoking Sarbox tend to lose. For more, click here.
The Department of Justice is reportedly supporting Peter Rost's appeal of the prior qui tam case. To quote from the legal brief, "the allegation of a specific false claim is not an absolute prerequisite to pleading a viable FCA claim....The strength of the inference of fraud on the government...
A federal appeals court recently dismissed Mark Livingston's potentially precedent-setting lawsuit (background here) invoking Sarbanes-Oxley in connection with allegations of GMP non compliance. For more, read on. His lawyer says he will appeal again, noting that it was a split decision.
Have been away from the epicenter of political corruption for a while. New York is quite a bit tamer on that score than Chicago. Not so its tabloid headline writing (especially at the New York Post), which is as brilliant as it is uncivilized.
Unfortunately, there is a "Jekyll and Hyde" aspect to many pharma companies today as they struggle with the dictates of shareholders and the whole blockbuster model. Nowhere was that more evident today than in two articles received within hours of each other.
Reading the resumes of some past FDA commissioners can make anyone feel like an underachiever---consider Mark McClellan, or David Kessler, who snapped up a law degree from the University of Chicago while a medical student at Harvard Medical School and went on to make healthcare wonk history.
Not ANOTHER pharma whistleblower-turned-writer! John Mack at Pharma Marketing blog writes that he was recently contacted by John Virapen, a self-proclaimed whistleblower whose unexpected career odyssey began, like that of another more famous former pharma executive, in Sweden.
21 CFR Part 11 noncompliance is a whole lot less sexy than the colorful sales and marketing pecadillos the industry has seen so far this year, but it is a main theme in Mr. Olagunju's complaints against Novartis and a recurring theme in 483s and regulatory problems. "IT is still...