Concerns Over Valeant Lead to Troubles for Other Companies
With Valeant facing constant criticism about their business model, other pharmaceutical companies following similar business models are starting to come under the magnifying glass.
Horizon Pharma PLC and Mallinckrodt PLC are two large companies often compared to Valeant. Their shares of stock prices have fallen roughly 25% in the past three months. Concordia Healthcare Corp., another company frequently compared to Valeant, has seen its shares fall 42% in that three-month period. All together, the three aforementioned companies have lost more than $4 billion in market value since late August.
Similar to Valeant, Horizon, ...
Source: Policy and Medicine - December 8, 2015 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Supreme Court Rejects Former Biotech CEO Free Speech Argument
After years of battling authorities, W. Scott Harkonen has lost his battle to overturn a 2009 conviction for wire fraud in connection with disseminating false and misleading statements in a press release about clinical trial results for a drug that was sold by a biotech where he had been the ceo. Earlier this week, the US Supreme Court declined to hear his appeal.
Although there was considerable uncertainty about whether the justices would act on his petition, the case was, nonetheless, being closely watched if only because Harkonen and his legal team made a point of raising First Amendment and commercial speech rights, wh...
Source: Pharmalot - December 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Criminal Hype - Overstating the benefits of a drug lands a former biotech executive in home detention.
W. Scott Harkonen, the former CEO of InterMune, is spending his days confined to his home in San Francisco as part of a six-month penalty for exaggerating the benefits of the firm’s interferon gamma drug Actimmune in a press release. As any reporter can attest, press releases often overstate the importance of a molecule or a scientific finding, but to jail the source of a statement is exceptional. “If you applied this rule to scientists, a sizable proportion of them might be in jail today,” Steven Goodman, a pediatrician and biostatistician at Stanford University, told The Washington Post.
The Post this week took a ...
Source: PharmaGossip - September 25, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
When Does a Biotech Press Release Constitute Fraud?
What can you say in a press release about a clinical trial? "Darn near anything, apparently" will be the response from many people who've been seeing them over the years. But really, what can you say, legally? Is there some point where you've clearly crossed the line into fraud, or are all these things just varying interpretations of scientific data?
That uncomfortable question has been working its way through the court system in the person of W. Scott Harkonen, former CEO of Intermune. This case is back in the news thanks to a long article in the Washington Post (pointed out to me by a reader of this blog in the comments...
Source: In the Pipeline - September 24, 2013 Category: Chemists Tags: Business and Markets Source Type: blogs
Former Biotech CEO Asks Supreme Court To Review Free Speech Rights
Four years ago, W. Scott Harkonen was convicted of wire fraud for allegedly skewing the results of a clinical trial in a 2002 press release about the effectiveness of a drug. And he unsuccessfully appealed on the grounds that prosecutors trampled his First Amendment and commercial speech rights. Now, he is urging the US Supreme Court to rethink his conviction.
At issue is a press release that the former Intermune ceo (ITMN) issued containing results of a clinical trial for a drug called Actimmune. The trial failed, but the release stated a sub-analysis showed the drug helped patients with a fatal lung disease called idiopa...
Source: Pharmalot - August 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Impact of Caronia Case: What Happens Next?
Last month, in a landmark ruling, the United States Court of Appeals for the Second Circuit in United States v. Caronia, vacated the criminal conviction of a pharmaceutical sales representative who was found guilty of conspiracy to introduce a misbranded drug, under the Food, Drug & Cosmetic Act (FDCA), because he spoke about off-label uses of a particular drug. The court held “that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”
In a client alert written by the law firm Arnold & P...
Source: Policy and Medicine - January 17, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
