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April 4, 2019

Off-label Treatment in Otolaryngology—A Cautionary Tale

Author Affiliations
  • 1Department of Otolaryngology–Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts
  • 2Harvard Business School, Boston, Massachusetts
  • 3Department of Otolaryngology, Harvard Medical School, Boston, Massachusetts
JAMA Otolaryngol Head Neck Surg. 2019;145(5):399-400. doi:10.1001/jamaoto.2019.0150

In July 2016, a Massachusetts jury convicted 2 former Acclarent executives on 10 misdemeanor counts of introducing adulterated and misbranded medical devices into interstate commerce.1 The case (USA v Facteau et al) concerned a medical device known as the Relieva Stratus MicroFlow Spacer (Stratus; Acclarent). According to the US government, the executives marketed the Stratus as a steroid delivery device despite prior rejection of that indication by the US Food and Drug Administration (FDA). Following the conviction, Acclarent agreed to pay the US government $18 million to resolve allegations that the company led otolaryngologists who were using the Stratus for postoperative steroid delivery to file false claims to federal health programs. Notably, the settlement was not a determination of culpability. This legal dispute provides insights into the implications of using drugs and devices for unauthorized indications and the ongoing debate over “off-label” promotion.

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