Tag Archives: Department of Justice

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



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)


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

Pharma Petitions FDA for Binding Off-Label Rules


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

Top Three Off-Label Marketing Strategies and Tactics


The most common strategies and tactics used by pharma companies to engage in off-label marketing is explored in detailed in “Strategies and Practices in Off-label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints,” by Aaron S. Kesselheim, Michelle M. Mello and David M. Studdert from Harvard  and Brigham and Women’s Hospital and published in PLoS MedicineContinue reading

FDA Issues Non-Binding Criteria for Executive Crimes

Author:  Mary Holloway

One big question arises when considering the implications of the Park Doctrine: what factors will the government consider in selecting misdemeanor prosecution cases? The FDA released their answer last month. Its Regulatory Procedures Manual asserts that when considering misdemeanor prosecution against “a corporate official,” the individual’s position, relationship to the violation, and whether they could have prevented it are relevant issues. The following criteria are also listed as considerations. Continue reading