Tag Archives: Medical Device

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

7 GPP Stories from Social Media, week of 11/25/2011


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 GPP stories about the consequences of getting marketing wrong (including jail time for execs at one company and just-shy-of-a-billion-dollar settlement for another), suggestions on how to get marketing right, and some insights on how to keep up with changing social media. Here are our top 7 GPP stories, posted this week on our Facebook page or tweeted on our Twitter handle @GPPnews.

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

Regulatory and Marketing Symbiosis from Concept to Commercialization (SLIDES)


Recently two Good Promotional Practices’ bloggers, Elsa and I, gave a live webinar for the Regulatory Affairs Professionals’ Society (RAPS), Regulatory and Marketing Symbiosis from Concept to Commercialization: A Good Promotional Practice. It was a fascinating topic to be invited to speak on and fun to create and present. There was much interaction during the webinar, so we would love to hear your input and questions as well. Here are the slides: Continue reading

2 Minutes to Win It (or Lose 50% of Video Viewers)


Did you know that only 75% will finish watching a one-minute video? And, by two minutes, 50% of your viewers have stopped watching.

Wistia mined the viewing data around the thousands of business videos they host in the cloud to discover this intriguing data and more. Here are some of their findings around viewership over time: Continue reading