Tag Archives: off-label

Medical Device Executives Found Guilty

Go Directly to Jail (23/366)

Author:

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

Author:

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

Attacks on FDA’s Aggressive Stance: Off vs. On-Label

Many manufacturers and industry watchers have recently renewed their challenges to the constitutionality of FDA’s expansive interpretation of off-label promotion on First Amendment grounds. Par Pharmaceutical Companies, Inc.’s recent lawsuit asked the courts to provide specific instruction and relief from prosecutorial threat for on-label communications to specific audiences who may also use their drug off-label. This is the latest in a series of attacks on the government’s aggressive stance on prosecution of pharmaceutical and medical device manufacturers and their executives for off-label promotion. Continue reading

New Lawsuit Chips Away at FDA’s Unwritten Off-Label Rules

Author:

Par Pharmaceutical, Inc. filed suit on October 14, 2011 to curtail prosecutions for off-label promotion based solely upon the physician specialties to which pharmaceutical manufacturers market their products.  In short, Par wants to promote its AIDS-related wasting drug, Megace ES®, for on-label uses but to physician specialties in long-term care and oncology settings that would likely use it predominantly for off-label indications.

Continue reading

5 Things You Didn’t Know About Off-Label Sales Compliance

Originally published in PharmaPhorum

Author:

Off-label sales compliance is difficult. There is subtlety to staying on message. Pharma sales representatives are highly mobile and verbal. Compliance and regulatory departments love paper to convey messages because they can match them up to corresponding policies. This makes the marriage of the two functions challenging. Continue reading