Originally published in PharmaPhorum
Author: Maureen Shaffer
Ethics is a broad field dominated by brilliant minds in academic institutions. We are all strapped for time and are constantly bombarded by information. How do you do the right thing? Continue reading
Tagged Compliance, consequences, promotion, regulatory, Sales Rep, Training
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
Posted in Legal
Tagged Compliance, consequences, FDA, Food and Drug Administration, off-label, Pharma
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 low rate of adverse events in social media, data-packed slides on digital marketing, including iPads and sales at slides 30+, and Google+ for pharma. Here are our top 7 GPP stories, posted this week on our Facebook page or tweeted on our Twitter handle @GPPnews.
Posted in Editor
Tagged Facebook, FDA, Food and Drug Administration, iPad, Marketing, Med Dev Sales, Pharma, physician, Social Media, Twitter
Marketing the positive. It is what medical device marketers try to do every day. Recently, I spoke with a few medical device companies about physician payment disclosures. Everyone wants to do the right thing. However they don’t want to reveal too much, perceiving this as negative news. I disagree.
Tagged Compliance, disclosure, Marketing, patient, patients, physician, ppaca, The Sunshine Act
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.
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