News Week in Review, September 9, 2013

The PharmaCertify Team

That plaintive wail you heard in the distance last week may have actually been the low groan of children across the country as they boarded buses, or trudged their way back to school last week. With the passing of Labor Day, summer came to an unofficial end, and schools welcomed al (those eager and those less enthusiastic) back to reality. And for those of us who have aged beyond the school years, a heavier rush hour commute was our welcome back to reality. Good times all around. Enough waxing poetic, it’s time to swing open our own school doors and ring the first bell on this week’s News Week in Review.

A new survey shows that physicians need more education about the Sunshine Actor. The survey shows a ten percent increase in physicians who say they are “somewhat aware” to “very aware” of the law’s requirements. However, almost half of the respondents stated that they are unaware of the law. The survey also delves into the impact of the law on industry-physician relationships. Almost 40 percent of the physicians say they believe the law will negatively impact their relationships with the industry, and 21% said they would end their relationship with a company if inaccurate payment information is made public.

A federal Circuit Court has offered a whistleblower an eighth opportunity take what some would consider to be a generous makeup test. The court asked for yet another amended complaint from the whistleblower, who had filed a False Claims Act case against Bayer. The whistleblower alleges Bayer hid the dangers of two if its drugs and provided kickbacks when promoting those drugs. She claims that when she objected to the marketing tactics, she was fired. The seventh complaint alleged violations of the false claims acts of twenty one states, Washington D.C. and New York City. The Circuit Court judge tossed the state claims, along with her emotional distress and misbranding claims, but gave her thirty days to file an amended complaint.

Major Pharmaceuticals found itself in detention as a result of its settlement with Texas. The company agreed to pay $5 million to settle claims it misreported prices of generic drugs, which resulted in the state overpaying for the drugs. The case was initially brought by whistleblower, Ven-A-Care Pharmacy, and the state recently decided to join the case.

In China, foreign pharma companies haven’t exactly been the teacher’s pet lately. But, the chair of the European Union Chamber of Commerce in China’s pharmaceutical work group, Bruno Gensburger, said China is unfairly targeting foreign pharmaceutical firms in its bribery and price fixing investigations. Gensburger said the targeted firms have global SOPs in place and have generally been operating in a responsible manner. He went on to say that no Chinese company has been targeted for investigation.

In its recent analysis of the global reach of the Sunshine Act, the law firm of Fulbright & Jaworksi LLP explained that Sunshine has applicability to foreign firms that have a business presence in the U.S. CMS has established an applicable manufacturer as one having a physical location in the U.S. or conducting business in the U.S., either directly or through a legal representative. Manufacturers need to consider payments made to U.S. physicians who practice abroad, but are actively licensed in the U.S.

Well, the dismissal bell is ringing on this edition of the News Week in Review. The start of a new school year reminds us that 2014 isn’t far away and this is a great opportunity to review your compliance curriculum and see where a fresh take might be needed or a new topic could be added. From Commercial Compliance Overview, to Good Promotional Practices to the Sunshine Act, PharmaCertify offers the up-to-date training your learners need to help integrate critical compliance awareness into their daily activities.

Have a great week everyone!

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