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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? Continue reading