Week In Review, May 13, 2011

The PharmaCertify™ Team

It’s Friday Saturday (I think Friday the 13th got the better of us)!  Woo Hoo!  Well some of us are woo hooing anyway.  It’s Friday the 13th! (insert scary music here) For all the friggatriskaidekaphobics out there, take heart.  There’s only one more Friday the 13th left this year. So step away from any ladders, don’t touch any mirrors, check for black cats, and then bathe in the soothing light of your monitor as you read this week’s PC News Week in Review.

The two big stories of the week happened in the courts. First there was the guilty verdict in the FCPA case against Lindsey Manufacturing. The jury returned a guilty verdict making Lindsey Manufacturing the first company to be found guilty in a jury trial of bribery under the FCPA.  Sentencing in the case will occur in September. Lawyers for the government called the verdicts a milestone in enforcement efforts, and said Lindsey would not be the last company found guilty at trial. Lindsey is appealing the decision. Lawyers for the company have filed a motion to dismiss based on government misconduct. This one ain’t over yet folks.

On the flip side of the coin, the government lost in its efforts against former GSK lawyer, Lauren Stevens. The government alleged that Ms. Stevens made false statements and obstructed an investigation in to GSK’s marketing practices of Wellbutrin. The judge acquitted Ms. Stevens before the case ever reached the ears of jurors. In a rare move, the judge basically called the government out on the carpet saying Ms. Stevens should never have been charged with anything, and it would be a “miscarriage of justice” to continue the case. The defense’s argument had been that Ms. Stevens had conducted herself appropriately in her representation of her client; even seeking the advice of outside counsel. The judge agreed, and he further stated there was “enormous potential for abuse in allowing prosecution of an attorney for the giving of legal advice.” Government lawyers felt the case was well-founded and deserved a chance to be heard by a jury. The decision by the judge dealt a blow to the government’s efforts to hold individuals accountable for corporate misconduct.

Thomas Fox has written a strong blog entry on the impact these two cases could have on the compliance officer position.

The OIG went on “damage control” this week with the release of a fact sheet in the matter of Forest Labs and the exclusion notice to its CEO, Howard Solomon. The fact sheet was an effort to clear up what the agency referred to as “inaccuracies in the media.” The sheet explained the exclusion authority available to HHS through the Social Security Act, the conditions by which the agency may exclude a person, the exclusion process, and the details of the recent settlement with Forest Laboratories. The OIG made clear that Howard Solomon has not been excluded from participating in federal healthcare programs.

On a more upbeat note, the OIG announced a free webinar on healthcare compliance for providers. The webinar is a part of the HEAT initiative, and will teach providers the basics of healthcare compliance, how to cultivate a culture of compliance, and what to do if an issue arises. The webinar will be held May 18th, and no registration is required.

This week, Ernst and Young published results of research that showed the oil and gas industry was most likely to face prosecutions under the U.K. Anti-Bribery Act, with life sciences companies coming in second. The research is based on FCPA prosecutions since the inception of the Act.

And speaking of the FCPA, SciClone announced the findings of its internal investigation of possible FCPA violations. The company found possible violations did exist, and cited a lack of internal controls and lack of transparency between the US and its China operations. Based on recommendations by the investigatory committee, the Board of Directors directed the company to take a number of remedial measures, including a revamp of company policies on the FCPA and their policies regarding, meals, honoraria and entertainment. The recommendations also included expanded training to employees on the FCPA and other anti-bribery, anti-corruption laws.

An article on Boardmember.com examined the building of a compliance program at Medicis, a dermatology company. While in the midst of a government investigation, Medicis’s Board decided to transform its compliance efforts with an emphasis on going beyond the minimum government expectations.  Enter new Compliance Officer, Seth Rodner. He removed the compliance function from legal, where it resided when he was hired. Rodner faced the challenge of not only transforming the compliance function for the company, but also introducing compliance concepts to the aesthetic end of the business, which does not face the same level of scrutiny as the therapeutic side of the business. With the support of the Board of Directors and upper management, he was able to do just that.

Our final story this week comes from the “she did what?!” file. Warner Chilcott received a letter from the FDA regarding a video a sales representative posted on YouTube to promote an osteoporosis medication, and, wait for it…this was at the direction of her district manager. (gasp!) The 60 second video failed to present a number of FDA requirements for advertising and labeling such as fair balance and drug indication. You know, the minor details. This was the only video cited in the letter and not surprisingly, it was removed from YouTube quickly. It may be Pollyanna-ish, but we have to believe that this rep and her district manager simply acted out of ignorance. Worried the reps at your company are capable of the same mistake? We have training that will help.

That’s the round up for Friday the 13th  (reprise scary music here). While some may find Friday the 13th scary, compliance training doesn’t have to be.  Whether you’re looking to expand FCPA training, or equip sales reps with what they need to know to stay compliant with federal and state laws governing interactions with healthcare providers, we can help. Check out our suite of compliance training topics at www.pharmacertify.com.

Have a great weekend everyone!

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