Tag Archives: DOJ

7 GPP Stories from Social Media, week of 12/16/2011

 

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We mine social media every week for the proverbial gold nuggets for pharmaceutical and medical device sales, marketing, legal, regulatory and compliance. This week was has GPP stories about iPads in healthcare marketing, settlements with DOJ for tens of millions, and a look into the future for social media and healthcare marketing. Busy week.

Here are our top 7 GPP stories, posted over the last week on our Facebook page or tweeted on our Twitter handle @GPPnews.

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Medical Device Executives Found Guilty

Go Directly to Jail (23/366)

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Three of the four former Synthes executives who pled guilty to charges under the Park Doctrine were sentenced to jail time and large fines recently. The four men were charged for training and supplying doctors with bone cement to repair fractured vertebrae in spinal surgery, an indication that was off-label according to FDA. Continue reading

7 GPP Stories from Social Media, 11/11/11

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We’re mining social media every week for the proverbial gold nuggets for pharmaceutical and medical device sales, marketing, legal, regulatory and compliance. This week has updates on DOJ enforcement, patient perspectives, and getting more from the Web we weave. Here’s our top 7 GPP stories, posted this week on our Facebook page or tweeted on our Twitter handle @GPPnews.

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Pharma Petitions FDA for Binding Off-Label Rules

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Eliminating illegal off-label promotion while engaging in legal scientific discourse around unapproved uses to ensure patient safety is a difficult line to walk for medical device and pharmaceutical companies. Today, the current broadly-written laws are open to expensive and retrospective interpretation delivered by the FDA, DOJ  and HHS via detailed warning letters, untitled letters, CIAs and DPAs. This is unproductive.

Seven pharmaceutical companies filed a Citizen Petition to FDA for Off-Label Guidance on July 5th Continue reading

7 New Insights to Preventing Off-Label Sales Promotion

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I was invited to present at a recent meeting of the AdvaMed Emerging Growth Company Council. My presentation on “Preventing Off-Label Sales Promotion” generated much interesting discussion. One passionate individual debated that sales people were not to blame and that they were simply at the receiving end of internal strategies and dictates. While studies support that corporate strategies were to blame in the past, lawyers think that is becoming more rare, especially in pharma.

View the slides of my presentation here and share your thoughts:

Key Questions

  • Do you think sales is simply an easy target for government investigators pursuing illegal off-label activity?
  • Or, do you think sales is still on the receiving end of bad direction? Is the same true in pharma and medical devices or is it different?

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