By: Alaina Confer, CIS Compliance Specialist
Direct-to-Consumer (DTC) advertising by the pharma industry for prescription medications has been under scrutiny for many years. Now the medical device community is dealing with similar pressures. Although medical device DTC advertising may be less common, we are nevertheless being exposed to it. The poster on the waiting room wall of the Orthopedics office, advertising replacement knees for women, is not geared towards medical professionals.
In mid September, the US Senate heard from the Center for Devices and Radiological Health[i] (CDRH), which explained that the misbranding of devices in DTC advertising is usually not discovered until trade complaints are received. Since device manufacturers are not required to submit promotional materials to the FDA at the time of dissemination, involvement from the CDRH’s Office of Compliance is mostly post hoc. Even so, 20% of warning letters issued in the last 12 months by CDRH address product misbranding[ii]. But should all device manufacturers be required to submit promotional materials to the CDRH prior to dissemination? I don’t think it will be long before promotional submissions become a requirement for restricted devices (i.e., devices for which the FDA is authorized to restrict the sale, distribution, or use).
For non-restricted devices, the Federal Trade Commission (FTC) regulates advertising, but what kind of advertising? Who is regulating the promotion of non-restricted devices from device manufacturers to healthcare professionals? I ask this question because I’ve had conversations with former sales professionals who had experience in this environment. One made references to using slander of competitors as a sales tactic. The other indicated cold calling with the promise of free samples for trial. These certainly aren’t new sales tactics, but when it comes to healthcare it takes on a new light. When dealing with a patient with a compromised immune system, do you want to be trying a new product that it turns out has a higher rate of infection than its competitor? Not really. But as a healthcare professional you don’t want to limit yourself or your institution from advancement because you are afraid to try a product either.
I predict the requirement for submission of restricted device promotional materials to CDRH at the time of dissemination will come to fruition within the next two years. How long do you think device manufacturers will be able to keep up their sales tactics for non-regulated devices before they come under higher scrutiny?