Category Archives: Pharma Sales

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

Originally published in PharmaPhorum

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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

5 Ways to Make the Most of Your Streamlined Sales Force

Originally published in PharmaPhorum
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50,000 jobs were cut by pharma in 2010, and in July 2011, “Thanks to Merck, pharma’s July job cuts outpaced layoffs announced in every other industry, Challenger, Gray & Christmas reports. The drug business accounted for 13,493 announced cuts – and 13,000 of that was Merck”, according to FiercePharma. Dire reports of “soon robots and drones will rule” in the comments fueled the raging flames.

Pharma reps are trying to cover more territory with less money while driving more written prescriptions. Lacking a fairy godmother or a magic wand, what can you do? As a sales manager or a marketing manager, how can you accomplish more with less pharmaceutical sales reps? There are no easy answers, but here are five steps for forward motion towards that goal:
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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

Happy Anniversary for FDA Bad Ad

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In November 2010 we reported on the FDA’s Bad Ad Program, which asks physicians to anonymously report misleading advertising and off-label promotion by pharmaceutical sales representatives. Last March, Doctor Directory, a leading market service company for the healthcare industry, conducted a survey to measure physicians’ attitudes toward the initiative. 90% of over 1,000 practicing physicians said that they would be at least “somewhat likely” to report questionable behavior. Now, just in time for the 1st anniversary of the Bad Ad Program, the FDA has released their results of the measure thus far. Continue reading

OIG Executive Exclusion Authority Alarming

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Last week the Office of Inspector General (OIG) released a fact sheet to correct what it characterized as “inaccuracies” in the media coverage surrounding the notice of potential exclusion received by Howard Solomon, CEO of Forest Laboratories. The fact sheet clarifies that the OIG has not excluded Mr. Solomon from Federal health care programs, but its broader purpose appears to be to reiterate the OIG’s permissive exclusion authority and summarize the process it will follow as it expands its use of the authority against officers and managing employees at pharmaceutical and medical device companies. Continue reading