Doctors’ Off-Label Tightrope

Author:  Sean McCarthy

When a drug, biologic, or medical device is used “off-label”, what does this mean? FDA clears/approves a given use or indication. Physicians are then free to make their own decisions based on how a device is used based on their best judgment. In other words, it is perfectly legal in the United States for a physician to use a drug or device for “off-label” use. However, it is unlawful to market, advertise or otherwise promote the off label use of a device or drug. Well, we already know this right? Based on the flurry of DOJ activity and the FDA aggressively pursuing the Park Doctrine, companies must keep the practices of their marketing and sales department in check to ensure compliance.

However, read that closely, “it is unlawful to market, advertise or otherwise promote off label use of a drug.” What if the hospital or physician group is doing the marketing themselves, not the company? We’ve all seen the billboards or newspaper ads promoting a latest treatment option from their physicians. Hospitals are competing harder than ever to bring patients to their doors, what’s to stop them from stepping over the same lines that the companies may have, either willingly or not?

Take Atrial Fibrillation (AF, AFib) as an example, there are very few drugs or devices that have approval to “treat atrial fibrillation”—maybe a handful all together. Yet upwards of 2.5 million Americans suffer from this debilitating irregular heart rhythm, and physicians are using an array of drugs and devices to treat this disease off-label. So, now the hospital or physician promotes their latest treatment for the disease on a billboard or newspaper article to communicate their ability to help AFib patients. Isn’t this the same thing as a company promoting off-label use? State Attorney Generals (AGs), DOJ and FDA must be taking notice. They drive by the same billboards we do and read the same newspapers.

Rumors abound in the field of this actually occurring out there now. I recently heard of a state AG investigating a doctor directly on his referral patterns and/or advertising activities. So, now in the field you as a sales rep or manager need to be aware of protecting your company, management AND educating your customer, the hospital/ASC and the physician, from stepping out across the line. All from the front line while maintaining your sales results.

Well, the last few weeks we’ve discussed the horror stories and how much the world has changed in medical and pharma sales. In future blogs we need to begin discussing solutions for how to get along in the current environment.

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Related links:

Off-Label Promotion is not False Claims: Medtronic and AFib

AAOS Position Statement on Off-Label Use – Great Primer for Physicians

Great Summary of the Fine-Line Differences between Legal Use and Illegal Promotion at MDDI

One response to “Doctors’ Off-Label Tightrope

  1. Pingback: Top Three Off-Label Marketing Strategies and Tactics | Good Promotional Practices

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