Week In Review, June 24, 2011

The PharmaCertify™ Team

Last Tuesday marked the “official” first day of summer! Hooray! Time for sun, sand, long days and lemonade. So just kick back and enjoy a tall glass of lemony goodness as you read this week’s PC News Week in review.

Besides the summer solstice, the other big news of the week was the 6-3 Supreme Court decision striking down Vermont’s ban on data mining. The 2007 Vermont law prohibits the sale and use of prescriber data for the purpose of marketing or promoting prescription drugs, unless the physician specifically gives permission for his or her data to be sold. The law was intended to hold down prescription drug expenditures and protect physician privacy. IMS Health and the other appellants argued that the law infringed on free speech rights. The court agreed, saying while praise worthy, Vermont’s efforts to hold down costs and protect the public health could not infringe on the free speech rights of others. Dissenting justices felt the law only affected one type of communication, and that perhaps the law would lead to companies developing better sales messages.

Nearly 40 states and the District of Columbia are basking in the warmth of a $41M settlement with GSK. The suit, headed by Oregon and Illinois, centered on manufacturing practices by GSK and a subsidiary located in Puerto Rico. The suit contended that the companies violated consumer protection laws. GSK settled federal false claims allegations on the same matter in 2010.

With the Massachusetts State Senate considering repealing the State’s gift ban, House Speaker, Robert DeLeo stepped up to the plate and said the ban is hindering job creation in the state. The Speaker said he had spoken to restaurant owners as well as those in the convention business and found companies are shying away from bringing business to Massachusetts due to the ban. While supporters of the ban contend that it is necessary to protect physicians from undue influence by drug and device manufacturers, one Massachusetts doctor says the ban actually hurts patient care. In an editorial published in the Boston Globe, the doctor points out the education and information gained from drug and device makers is important for the advancement of patient care and the additional compliance burden only hurts innovation.

Riding the wave of an investigation by two news outlets, two US Senators have demanded Medtronic turn over documents related to payments made to physicians involved with clinical trials of its spine surgery product, Infuse. The senators were troubled by allegations in articles from the Journal-Sentinel and MedPage Today that prominent surgeons who had financial ties to Medtronic and were involved in Infuse clinical trials, failed to report complications with the product in medical journals. A Medtronic spokesperson said the company would comply with the request.

And finally, as if summer wasn’t fun enough, the UK Anti-Bribery Act goes in to affect on July 1. Enjoy!

How was that for the start of your summer reading? Light and full of fun, the perfect summer story, right? Okay, maybe not. However, we can help you shed light on today’s compliance issues with custom-developed training tools or our off-the-shelf, customizable modules covering a variety of topics including state laws, the federal Anti-kickback Statute and the FCPA.

Have a great summer week everyone!

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