It can be a bit tricky for medical device makers to make sure their advertising materials are following the letter of the law in the eyes of the FDA.
That, says lawyer August Horvath, is because the agency doesn’t give device makers many particulars to go on, and instead largely has them adhere to the detailed advertising rules for drugmakers, many of which may not apply very well to devices.
In the recent FDAnews webinar Advertising Medical Products: Real-Life Scenarios that Illustrate What You Can and Cannot Say, Horvath outlined some of the differences in advertising regulation for both groups, offered advertising guidance to device makers, and shared an illustrative example of a device maker seemingly flouting the FDA’s false advertising rules.
“It’s obvious that the FDA is not as used to regulating medical devices as it is to regulating drugs,” said Horvath, an antitrust partner at the law firm Kelley Drye, with 20 years’ experience defending drug and device makers against false-advertising claims. “They don’t provide as much guidance for medical devices, and you have to apply the logic that you would use for a drug to the device.”
Explained Horvath, like drugmakers, its incumbent upon devicemakers to ensure their advertising materials are not false or misleading in any way, and also that the materials present a fair balance between information about effectiveness and information about risk.
Failure to do this — overstating the efficacy of the product by going either beyond the indication, or exaggerating the extent to which it has been shown to do what it’s supposed to do, or understating the side effects — makes your drug or device “misbranded” in the eyes of the FDA.
But unlike drugmakers, said Horvath, devicemakers don’t have to submit advertising to the FDA at the time of dissemination, so there’s no pre-approval process. This sounds like freedom, but instead it can be a burden for device makers.
Said Horvath, surveillance of device advertising is more post hoc, with the FDA monitoring media and device trade shows for compliance, and following up on the inevitable complaints from competitors.
“I wouldn’t say it’s the Wild West, but it’s a little bit less of a hands-on enforcement regime in medical devices,” said Horvath.
It’s not too hard to transport the concept of it being false or misleading directly from the drug world, said Horvath. It’s where you go beyond that that gets tricky. Horvath used the recent example of the headset SyncThink, a 510(k) device cleared as the substantial equivalent of a device whose indication for use was eye tracking to measure visual tracking impairment.
But SyncThink’s makers got a warning letter after allegedly marketing this device as a diagnostic for cognitive impairment, saying that it was used as a concussion diagnostic, and claiming that it would be used for athletes and military personnel to determine whether their head trauma had caused brain injury.
“What they did in the FDA’s view was to change the indication, which is a no-no,” said Horvath.
After telling the FDA it would stop, the company re-tweeted information about traumatic brain injury. Is this a violation since its product is not cleared for anything related to traumatic brain injury? That’s still unclear.
“If you re-tweet something like this and it is in a promotional context and part of a Twitter feed that people understand is for marketing, I think this is still talking about your product being used for concussions in a way that carries some risk,” offered Horvath, adding, “This is not a settled area in any aspect of advertising law, whether we’re talking about drugs or anything else. It’s something we argue about quite frequently in the field.”
Access the webinar, Advertising Medical Products: Real-Life Scenarios that Illustrate What You Can and Cannot Say, here: www.fdanews.com/products/54811. — Suz Redfearn