Week In Review, December 9, 2011

The PharmaCertify™ Team

The holiday season is in full swing and it’s time to enjoy all of those wonderful family the traditions. Perhaps one of your traditions is curling up on the couch with the family to watch all of the Christmas specials and movies that make their annual appearance on television. Sure, most are available on DVD these days, but somehow it isn’t quite the same as gathering the troops on that one night when your favorite movie airs. But before you go home to scan the channels in search of the Island of Misfit Toys or the friendly streets of Whoville, warm up with this delightful tale of the news that was in this week’s PC News Week in Review.

Postal workers in Britain are having their Christmas tip Scrooged out from under them, thanks to the UK Bribery Act. It seems the postal service has put postman on notice that if they accept a Christmas tip of more than 30 pounds, they and the well-meaning person giving the tip could be accused of bribery, under the UK Bribery Act.

Want the whole world to know your blood sugar levels the way all of Bedford Falls knew about George Bailey’s legal trouble? Well, maybe the whole town won’t know, but if you use medical apps to track and store everything from your blood pressure readings to your medications, you may be surprised to know your personal information is not protected by HIPAA. Unlike a physician, app developers are not subject to HIPAA, and therefore any data stored by a developer is not subject to the law’s security or privacy provisions. Consumers need to check the privacy policy of the developer, because unless otherwise stated, the data could be sold.

The DOJ has filed an appeal after the dismissal of the Lindsey Manufacturing FCPA case last week. The judge cited “flagrant” misconduct by the prosecution as the reason for the dismissal. The DOJ may be looking for a Miracle on 34th Street though since the appeal has to be approved at three levels before it can even move forward.

The dismissal of the Lindsey Manufacturing case was cited by another FCPA defendant in a motion before a court in Texas. The defendant in the Texas case is arguing that prosecutors cannot include evidence of the bribe involving a Ferrari and a yacht in his case since it was used in the Lindsey case. Both companies used intermediaries headed by the same person and the Ferrari and the yacht were not the only similarities between the two cases.

Quick! Hide Frosty the Snowman! Senators and Kohl and Grassley are calling for Sunshine. The Senators have called a hearing for December 15 titled, “Parting the Clouds: Implementing the Physician Payments Sunshine Act.” The purpose of the hearing is to discuss the release of the regulations and the impact of delaying those regulations.

Call out the Coal Elves; the industry is still Naughty vs. Nice when it comes to off-label marketing according to a Harvard study. Researchers reviewed past cases and noted that off-label prescriptions did not trail off until after settlements were announced. They claim that the current enforcement efforts are not enough of a deterrent to quell improper off-label marketing. The study recommends bigger fines and additional resources for enforcement.

They don’t need Twitter or a fancy Facebook. They just want simple resources at which they can look. For the Europeans down in Europe contests have no meaning, but information about diseases and conditions will leave them beaming. To the industry they say, “No thanks, we’re just not interested in your social media today.

Pfizer will no longer be Home Alone in deciding how to allocate funds for medical education. The company will split its medical education grants into two tracks. The first track will require an RFP submission and a board of outside, expert advisors will make decisions about the grant awards. The other track will be for unsolicited grants involving only live national or regional meetings.

Wrapping (pun intended) up the news is KV Pharmaceutical’s settlement with the government for $17 million to settle false claims allegations. The allegations stemmed from the now dissolved KV subsidiary, Ethex. The government alleged that Ethex misrepresented the regulatory status of two of its drugs.

That brings us to the end of this week’s PC News Week in Review. Now, go on home, pop some corn, make some hot chocolate and watch the Christmas movie or special of your choice. Have a great weekend everyone!

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