Medical Device DTC Ads: Spooky, Outrageous Claims & Unregulated! | Pharmaguy's Insights Into Drug Industry News |

The medical device industry’s first highway billboard advertisements recently sprouted along roadsides outside Minneapolis-St. Paul and atop buildings downtown, sparking new discussion about medical devices following the example of direct-to-consumer drug ads.

Placed for privately held local company Torax Medical Inc., the trailblazing ads depict, in one rendition, a ferocious science-fiction type monster inside a stomach under the exhortation: Contain the beast that lives inside you.

Device manufacturers do not have the barrier of stringent FDA regulation that the agency erects to control drug advertisers.

The Federal Trade Commission (FTC) has primary jurisdiction over device advertising, as it does over nonprescription drug advertising, which was the primary competitive marketing force that persuaded Torax Medical to put up its highway billboards.

In sharp contrast to FDA, FTC has a long history of lax regulatory oversight of both nonprescription drug and device advertising.

When patients claiming severe quality-of-life harms from LASIK eye surgeries turned to FTC for regulatory enforcement under its truth-in-advertising authority, the agency just wasn’t interested.

Thus regulatory barriers need not deter medical device manufacturers from advertising.

So what’s holding everyone else back?

The bottom line for both medical device and prescription drug marketers is that as long as their advertised claims are not false and/or misleading, neither FTC nor FDA seems to be inclined to launch prosecutions—notwithstanding opposition from organized medicine.