District Court Holds Corporate Integrity Agreement Obligations May Create "Reverse" FCA Liability in Cephalon Case
Last week, U.S. District Court Judge Thomas O’Neill of the Eastern District of Pennsylvania denied Cephalon’s motion to dismiss False Claims Act allegations brought by three former employees. Bruce Boise, Keith Dufour, and Andrew Augustine, joined by the United States, alleged that Cephalon promoted two drugs, Provigil and Nuvigil off-label (view the third amended complaint here). The complaint had additional weight due to the fact that Cephalon was under a Corporate Integrity Agreement during the alleged illegal conduct, which outlined “Stipulated Penalties for Failure to Comply” with a variety of comp...
Source: Policy and Medicine - July 27, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Modafinil and Cognitive Enhancement
There is some evidence of a cognitive enhancing effect of modafinil here. (Hat tip: Nicole Vincent) (Source: Neuroethics and Law Blog)
Source: Neuroethics and Law Blog - January 31, 2014 Category: Psychiatrists and Psychologists Authors: Adam Kolber Source Type: blogs
Kratom: Mitragynine For Beginners
An organic alternative to methadone?
A disclaimer: Everything I know about kratom, I learned on the Internet and in science journals. I have no real world experience with this opiate-like plant drug, haven’t used it, don’t know very many people who have. Although it comes from a tree indigenous to Thailand and Southeast Asia, and has presumably been around forever, a recent journal article referred to kratom as “an emerging botanical agent with stimulant, analgesic and opioid-like effects.” Which makes it sound like a combination of heroin, amphetamine, and strong weed. In reality, however, it is evidently a fa...
Source: Addiction Inbox - October 25, 2013 Category: Addiction Authors: Dirk Hanson Source Type: blogs
Nuvigil: Not Better Than Placebo for Depression Symptoms in Bipolar
Millions of people around the world rely on antidepressants in the treatment of clinical depression and, to a lesser extent, bipolar disorder. Over a dozen such medications exist, and many are also available in generic form.
But for reasons that scientists can’t yet adequately explain, some people don’t respond to many antidepressant drugs. And the drugs they do respond to may carry unwanted side effects that make taking the drug for any length of time downright challenging.
So drug companies are constantly looking for new drugs, new uses for old drugs, and new formulations of old drugs to help improve their b...
Source: World of Psychology - August 31, 2013 Category: Psychiatrists and Psychologists Authors: John M. Grohol, Psy.D. Tags: Antidepressant Bipolar Depression Disorders General Medications Research Sleep Stimulants Antidepressant Drugs armodafinil Batting Average Clinical Depression Depression Symptoms Depressive Symptoms Endpoints Excessive Slee Source Type: blogs
States Becoming More Aggressive Prosecuting Off Label Promotion
For the last several years, we have reported extensively about the government settlements, investigations, and prosecutions of pharmaceutical and medical device companies for various fraud and abuse, FCPA and FDA violations. Almost all of these cases has resulted in multi-billion dollar settlements, corporate integrity agreements and various other legal, regulatory and compliance obligations.
Consequently, a growing concern and trend that companies are now facing are separate and parallel civil and criminal enforcement actions at the state level for the same or similar conduct companies settled with the federal go...
Source: Policy and Medicine - May 24, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
