Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future? The Short Answer: No

The Department of Justice’s (DOJ) recent criminal prosecution of Vascular Solutions, Inc. (VSI) ended in a spectacular loss for the government. The defense rested without calling even a single witness, but the jury unanimously acquitted VSI and its chief executive officer of, among other things, misbranding products due to “off-label” promotion.

VSI’s Vari-Lase products were 510(k)-cleared by FDA for the ablation of superficial veins, but VSI allegedly promoted them outside the scope of clearance for use in perforator veins, which connect the superficial vein system to the deep vein system. Although this off-label promotion allegedly misbranded the product, the trial judge instructed the jury that such promotion is not per se illegal.