The PharmaCertify Team

For many of you, today is Friday, so we’re bringing you the news review a day early this week. If you are actually having Thursday on a Thursday, we hope you enjoy our little summary early, and hey, for kicks, read it again tomorrow. What would Friday be without it, right? On to the news….

To start, we’ll wind back to last Friday, with the news that the former InterMune CEO, Mark Harkonen, was sentenced to 6 months of home confinement and ordered to pay $20,000 in fines for his wire fraud conviction in the Actimune scandal. The government was asking for a 10 year prison sentence, but the judge said the government had failed to prove the press release at the center of the case had actually caused harm to anyone.

Our next case proves that doing the right thing does pay, but maybe it should just pay better. Last week we told you about the settlement of the false claims case against Mequon, the maker of Dr. Comfort inserts and shoes for diabetics.  One of the whistleblowers, a manufacturing worker, received a reward of $800,000, which after taxes and lawyer fees, will net the man about $250,000. Meanwhile, an executive of the company received a $4 million reward for his part in the case. While the manufacturing worker is happy to have received a reward, he is not happy that someone who he felt was part of the problem received immunity from the government and now has a substantial share in the award.

Ultimately these two individuals went to the government on two separate issues related to the case.  Each filed his own qui tam suit about a month apart. The government felt both cases had merit, and the two were combined and each individual received a share of the reward. It just so happened that the executive had the better paying dirt.

The hit parade of stories about local doctors being paid by pharmaceutical companies and the evils of these arrangements continued this week. On the hot seat this week were central FL doctors. When is sweeps period over?

Not to be out done, the Association of the British Pharmaceutical Industry is requiring companies to make public what they pay to physicians in consultant fees. This requirement is a part of the ABPI’s updated Code of Practice for the Pharmaceutical Industry, which becomes effective on May 1. Healthcare professionals will also be required to declare their ties to the industry when speaking or writing on behalf of a company, and companies will have to ensure the disclosure is made.

While we’re across the pond, Deloitte released the results of a poll in which 73% of respondents said they were not familiar with the provisions of the UK Bribery Act, which becomes effective July 1 (or 1 July for the internationally minded). Not surprising, considering the confusion that exists as to whom this law actually applies.  Deloitte conducted the poll during a webcast centered on remaining compliant with the FCPA while doing business in Brazil, Russia, India and China.

Back in the good ol’ U.S. of A., a Stanford University report calls in to question the safety of off-label use of an expensive blood clotting drug. The drug is supposed to be given to hemophiliacs, but the Stanford report found the majority of the drug’s use is off-label for non-hemophiliac patients undergoing certain surgical procedures. Due to the powerful clotting ability of the drug, researchers are concerned that  patients are at risk of developing dangerous blood clots, endangering the patient’s health with no notable benefits.

That’s our shortened week in the news. Enjoy your Good Friday, Earth Day and Easter holidays! We’ll see you right back here next Friday.

For those who are heading to SPBT in a few weeks, be sure to attend our workshop on compliance training, with Cinda Serianni of Gilead! To learn more about our suite of compliance courses, covering topics such as FCPA, On-label Promotion and the False Claims Act, visit www.pharmacertify.com.