Experts: Device Makers Evaluating Impact of Amarin Ruling

Device makers are paying close attention to a federal court’s ruling that Amarin can use off-label promotion of its cholesterol-lowering drug Vascepa, as long as the communication is truthful and not misleading, two experts say.

Debating the implications of the ruling, handed down last month in the U.S. District Court for the Southern District of New York, Ralph Hall, a law professor and counsel at Faegre Baker Daniels, and Global Policy Health Institute Director Timothy Mackey agree that the ruling will affect device makers, although the implications are potentially more limited.

Mackey points out that with the exception of combination products or extremely novel devices, innovation in the medical device arena can be more incremental. Most devices are approved through the 510(k) process, which requires companies to demonstrate that their products are similar to previously approved devices. “In that case the claims may be somewhat limited to what the previous device could do, and there may be more incremental claims associated with a device, versus a brand new pharmaceutical compound that treats a new mechanism of action,” he says.

Hall says free speech standards are the same for devices, so the ruling could affect promotion. He points out that many devices, such as scalpels, do not provide therapy, but are used as tools.

“So, you’re making more performance statements as compared to actual therapeutic statements,” Hall says. Whether a devicemaker meets the truthful and not misleading threshold can be measured through industrial product testing.

Hall says devicemakers are tracking the Amarin ruling, “but they always want to stay a bit below the radar screen.” The debate was sponsored by FDAnews. — John Bechtel