The PharmaCertify™ Team

Stockings hung? Presents wrapped? Run out of ideas for your Elf on a Shelf? Christmas Day is just about here! Woo Hoo! But before visions of Sugarplum Fairies begin dancing (rule 1, stay away from the punchbowl at the office party) or you face the challenge of another gingerbread man, we have some news from the world of compliance. We know it’s not necessarily as much fun as popping another rum ball, but it’s definitely more fun than facing the crowd at mall. So grab a cup of eggnog and check out the news that was in this week’s News Week in Review.

Break out the Christmas Crackers, our first story takes us across the pond to the U.K. Since the U.K. Bribery Act went “live,” there hasn’t been much noise on prosecutorial front. But don’t let the silent act fool you, there were a number of  significant developments with the law.  The Serious Fraud Office (SFO) issued new guidance and guidelines, largely revolving around self-reporting. The new head of the SFO made it clear that self-reporting was not a guaranteed way to avoid prosecution.

Now we’ll pass the paper crown over to the folks from the land down under. The Australian Competition and Consumer Commission (ACCC) has approved a pharmaceutical industry Code of Conduct, which will require companies to disclose how much they pay physicians in speaker fees and sponsorships to attend medical conferences overseas. The ACCC gave the industry two years, instead of the five that had been requested, to come clean on the payments.

Speaking of physicians, pharma, money and conflicts of interests, a joint analysis by the Milwaukee Journal Sentinel and MedPage Today found that committees responsible for writing treatment guidelines are rife with physicians who have financial ties to the pharmaceutical industry.  In their analysis, the publications looked at treatment guidelines for 20 of the top 25 drugs sold in the U.S. They found that the committees to be largely populated by doctors with ties to the industry and some panels did not require doctors to disclose those ties. In addition, guidelines were sometimes written without scientific evidence showing the drug is safe for use.

Cash for Christmas: some think it’s a thoughtless and callous idea, others think it’s filled with logic. We think the feds may be in the latter camp considering the number of settlements announced recently. This week’s givers are Amgen, Sanofi and after much wrangling, Orthofix.

Amgen will pay $762 million to resolve criminal and civil allegations it illegally marketed one of its products. The company pled guilty to misbranding and will pay $150 million in criminal fines and forfeiture. The remaining $612 million of the settlement is to resolve civil claims.

Sanofi will pay $109 million to resolve allegations that it violated the Anti-kickback Statute and False Claims Act. According to the DOJ, the company provided free samples of product to physicians in order to induce them to purchase the product. The company also submitted a false Average Sales Price (ASP) to the government.

Orthofix gained court approval on a $43 million settlement in an Anti-kickback case and the company will pay $7.6 million in criminal fines and $32.3 million to settle civil allegations. The whistleblower case alleged sales reps submitted false certificates of necessity to Medicare for several of the company’s bone growth stimulators. The company pled guilty to failing to disclose the information during a Medicare audit in 2008.

2013 planning and resolutions are in the air at the various government agencies who handle compliance matters. At the Food and Drug Law Institute’s “Enforcement, Litigation and Compliance” conference, Greg Demske of the OIG said the agency hopes to hold more roundtables with the industry in the coming year. Michael Blume of the Consumer Protection Branch (CPB) of the DOJ, discussed whistleblower cases and said CPB will most likely start imposing its own requirements on companies, in addition to those imposed by the OIG through CIAs.

The recent U.S. v. Alfred Caronia decision was a hot topic at the conference as panel members suggested the ruling could have implication on future calculation of damages to the government, particularly when false claims are involved.

That brings us to the end of this week’s Review. Time for us to sled off into the weekend and toward a joyous holiday! Or perhaps to fit in one more last minute trip to the mall.

Have a save and very Merry Christmas everyone!