Ethics and medical sales
Feb/20/09 13:28 Filed in: Medical devices | Pharmaceuticals
While searching for information on another blog entry of mine, I came across a story where a Stryker sales representative in Ohio pled guilty to felony “misbranding of a medical device.” As an executive and manager in the medical device and pharmaceutical markets, my rules were quite explicit to all sales people--do not violate applicable regulations and laws for marketing medical product. Stryker has a similar statement on its website (though I cannot know if they placed it there after the criminal actions, but most ethical companies have the policy in place).
There are many issues that make it difficult to implement this policy:
Most medical products companies (the vast majority, in fact) set a singular tone on labeling--don’t sell off-label. I worked for a company where the sales management would confiscate home-made sales pieces that reps constructed. Some companies make it clear that any sales representative that makes any off-label claims is immediately terminated. But there are rogues in sales and in corporate management, and I think prosecutions of medical products sales representatives will set the tone--don’t do it.
I haven’t a clue as to how many medical sales reps there are in the United States, but the number prosecuted for this off-label selling is so small as to be insignificant. The vast majority of medical sales reps are well-trained, ethical, intelligent, and professional. But I bet the next sales meeting for Big Pharm will include a review on off-label selling.
By Michael W Simpson
There are many issues that make it difficult to implement this policy:
- Frankly, the physician customer wants to do what they want with any device or drug. In my experience surgeons and cardiologists tend to “push the envelope” on technologies. Short of a strong contra-indication for a particular use, physicians will often use a product off-label.
- Oftentimes, there is high level pressure on sales reps to essentially “wink and nod” to the physician about off-label uses, hinting that it can be used safely. Companies will hand out copies of peer-reviewed medical articles that discuss future indications of products.
- Worse yet, there are often company cultures that establish confusing direction on off-label marketing. The legal and medical departments of a company may set strict regulations (as I bet happened at Stryker). But the sales and marketing departments may casually mention off-label uses. A sales rep, usually working independently, while fighting competition and pricing declines, is put in a difficult position--sell more or get fired.
Most medical products companies (the vast majority, in fact) set a singular tone on labeling--don’t sell off-label. I worked for a company where the sales management would confiscate home-made sales pieces that reps constructed. Some companies make it clear that any sales representative that makes any off-label claims is immediately terminated. But there are rogues in sales and in corporate management, and I think prosecutions of medical products sales representatives will set the tone--don’t do it.
I haven’t a clue as to how many medical sales reps there are in the United States, but the number prosecuted for this off-label selling is so small as to be insignificant. The vast majority of medical sales reps are well-trained, ethical, intelligent, and professional. But I bet the next sales meeting for Big Pharm will include a review on off-label selling.
By Michael W Simpson