Week In Review, November 18, 2011

The PharmaCertify™ Team

The wedding of the century…did you see it? We’re not talking about Kim and Kris (you can stop laughing now) or Albert and Charlene, or even William and Kate. Please! Those weddings were just the warm-up act to the wedding of Bella Swan and Edward Cullen, the heroine and hero of the Twilight series. Yes, the long awaited, much ballyhooed fourth installment of the series, Breaking Dawn – part 1, rolled out at theaters around the country. If you missed out on the early morning nuptials, you have come to the right place. We have something for you just as entertaining and no tissue is needed – this week’s PC News Week in Review.

We’ll start off by sinking our teeth into this story. An attorney breaks down the Sunshine Act for physicians. After an explanation of what the law requires, the lawyer then explains  the downside for physicians. Citing current media “exposés” of the financial relationship between physicians and the pharma industry, he shows how these articles generally paint a scurrilous picture of the relationship between the physicians and the industry. Since Sunshine will link the physician’s name with a dollar amount, he urges physicians to examine the risk of public exposure will have on their business and then take the appropriate action.

In a dramatic twist, a physician finds himself on the business end of an off-label lawsuit. Just who filed this suit? A medical device company. The medical device company, being sued by a patient over the off-label promotion of one of its products, has filed a cross claim against the patient’s doctor for using the product off-label. Pass the popcorn please.

Leader of the medical device approval reform pack, Senator Al Franken, told a group of Medtronic employees that he would be introducing a bill to help speed up the approval process for devices that treat rare diseases. The bill would allow companies to make a profit on these devices (which they currently can’t, unless the devices are used for children), and it would create provisions to allow experts who may have ties to the industry to serve on FDA advisory panels for these devices. Meanwhile, several Republican senators pressed the head of the FDA’s Center for Devices and Radiological Health for answers as to why negotiations for the device user fee have gone nowhere and why device approvals are so slow.

Senator Grassley has sent a request to Attorney General Eric Holder for information about the forthcoming FCPA guidance. Among the expected questions (e.g., when will it be released), the senator asked questions about whether safe harbors will be provided for gifts of minimal value; if clarity would be provided about the extent of liability one company assumes of another’s pre-merger or per-acquisition activities; and if guidance around DOJ’s interpretation of terms such as “foreign official” and “government instrumentality” will also be provided.

Speaking of those “cloudy” legal terms, the former president of a telecom company who received 15 years in prison for FCPA violations is appealing the verdict. His initial defense centered on the definition of “foreign official.”. Lawyers this time are taking the approach that the Haitian telecom involved in the case is actually a private enterprise, thus making the FCPA a non-issue.

You don’t need telepathic, clairvoyant or any other special vampire power to know where the bribes are occurring. Check out this cool interactive map that breaks down FCPA cases by sector, country and amount of money involved. And, in a final bit of anti-corruption news – spoiler alert; The DOJ and SEC say the FCPA investigations are a top priority for the future.

We’ll wrap this week’s news up with a new study that finds reports of adverse events on social media sites are about as rare as a vampire/human baby. A study of 224 pharmaceutical brands across various social media sites found reports of adverse events occurred in .3% of posts that mentioned the brands. Of those, only 14% contained reportable information.

Since we’re talking social media, let’s talk about compliance information on the go. Tablets and smartphones are making the process for sharing and gathering information more portable than ever. Our compliance apps run on multiple platforms and offer your field-based employees access to up-to-date compliance content where they need it most – in the field and on the go. To learn more about our Navigator suite of apps, check out the mobile learning page on PharmaCertify.com.

That brings us to the end of this week’s review. As exciting as the release of the near final chapter of the Twilight series is, I think we’ll take a pass. Instead, we’ll be saving our entertainment dollars for another long awaited film – the poignant tale of a group of has-beens and their struggle to climb back to the top. We hope you enjoy your weekend wherever it takes you!

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