News Week in Review, July 29, 2014

Physicians find confusion instead of data on Open Payments, a judge refuses to dismiss the false claims case involving Thalomid, FedEx is facing arraignment this week for shipping illegal drugs, and the SFO is teaming with the Chinese government on the GSK case.

Time to deck the halls and break out the It’s a Wonderful Life DVD. It’s Christmas in July! While the dog days of summer may seem an odd time for sugar plum fairies to be dancing through our heads, we can at least crank the air conditioning, don a really ugly reindeer sweater, and let our imaginations run wild. It’s time to rip the paper and ribbons off this week’s Compliance News in Review.

Some doctors unwrapped a confusing error message when they tried to access information in the Open Payment system last week. July 14th marked the first day physicians and teaching hospitals could access the information that has been reported about them in the system. A number of physicians reported that it took them up to an hour just to log on. Once logged in, some saw a rather ambiguous error message; “You have the following errors on the page. There are no results that match the specified criteria.” Although the physicians were unsure whether this was a bug in the system, or it really meant no payments were in the system, CMS said the message is clear and anyone with questions should call their helpdesk.

The sleigh ride isn’t over yet for Celgene. A federal judge refused to dismiss a false claims case brought against the company by a former salesperson. The case has drawn interest because it raises questions about when manufacturers can discuss the off-label use of products with physicians. According the whistleblower, initial marketing efforts for the drug Thalomid were focused on off-label uses. The company asked for a dismissal, saying the plaintiff failed to state a plausible claim. The judge disagreed, saying the plaintiff’s claims did lay out a sufficient case of wrong doing and that Celgene was “belied by its own evidence.”

The director in the charge of the lab where employees were potentially exposed to anthrax has resigned. Lax adherence to safety protocols in the lab led to the possible exposure. Luckily no one fell ill. An investigation into the incident has found that several other labs, some dealing with dangerous germs, were also not following proper safety protocols. CDC chief, Tom Frieden, said disciplinary action will be taken against those intentionally breaching safety protocol, or those who know of safety breaches but do not report them.

One of Santa’s helpers, FedEx, will be arraigned in federal court this week. The company was indicted for shipping drugs for illegal pharmacies. The government claims it repeatedly warned FedEx about shipping drugs for the pharmacies. FedEx says it ships millions of packages and cannot be responsible for policing the contents of each one. The company says it repeatedly asked for a list of shippers involved in shipping illegal prescription drugs, but was never provided one. United Parcel Service signed a non-prosecution agreement last year over similar charges.

The Serious Fraud Office (SFO) and the Chinese are caroling together in the GSK investigation. SFO chief, David Green, says this is the first cooperative case between the agency and the Chinese government. Green visited China earlier in the year, and said the Chinese government has a desire to deal with bribery and corruption. The SFO’s interest in GSK has expanded beyond the company’s business in China, and the agency is seeking help from whistleblowers regarding reports of bribery in the Middle East and Europe. GSK chief Andrew Witty says he remains “very concerned” about bribery allegations in China.

Even if you didn’t bother to break out the decorations for Christmas in July, planning for the actual, year-end festivities will be here soon after summer ends. And so will, the need to make your 2015 compliance training plans. The PharmaCertify™ suite of commercial compliance training solutions offers the up-to-date modules and mobile apps your staff needs to help them integrate good compliance practices into their daily activities.

Have a great week everyone, and happy holidays!

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