GAO Report Probes Device DTC Advertising

At the request of several Congressional requestors, the Government Accountability Office (GAO) has released a new report examining FDA and FTC’s oversight of medical device direct-to-consumer (DTC) advertising. The report could be an early signal of increased interest on Capitol Hill on regulatory enforcement of medical product advertising, leading to eventual legislation. It found that between 2018 and 2022, “FDA and FTC took 255 and 67 enforcement actions related to medical device advertising issues, respectively, according to agency officials.” GAO says that a literature search identified no studies that analyzed the effects of direct-to-consumer advertising of medical devices. It surveyed 11 stakeholder groups to identify the effects of, and concerns with, device DTC advertising. Seven of the 11 groups interviewed expressed general concerns associated with direct-to-consumer advertising of medical devices, such as:

• Information in the ads may not be truthful (two groups). 
• Ads do not contain adequate risk information (one group).
• Advertising can negatively affect the patient-physician relationship by interfering with the ability to arrive at the best treatment option (two groups).
• Ads can increase demand for the products, which can increase costs to the patient and the health care system or lead to unnecessary uses (two groups).
• Target audiences of some DTC ads may be vulnerable, including those with medical conditions (two groups).
• Consumers can be harmed by the advertised devices (two groups).

GAO’s evaluation also confirmed the agencies’ regulatory roles. FDA and FTC follow the roles and responsibilities outlined in a 1971 memorandum of understanding for their respective oversight of device ads. “FDA has primary responsibility for overseeing the truth or falsity of advertising for restricted medical devices, such as cardiac pacemakers and heart valves,” the report says. “In addition, FDA has oversight responsibility to ensure that, among other things, the information on all medical device labeling is not false or misleading.” 

FTC, on the other hand, has primary responsibility for the truth or falsity of advertising for all devices that are not restricted, including most over-the-counter medical devices and some prescription devices such as contact lenses and dental aligners. “FTC officials stated that the agency also has responsibility for overseeing the truth or falsity of advertising for devices that are marketed without having completed FDA’s pre-market regulatory process (also known as illegal devices),” GAO says. “FTC officials stated that, while FTC is focused on the advertising of illegal medical devices, the agency has the authority to regulate the advertising of all medical devices.”

In interviews with agency officials, GAO was told that both FDA and FTC have limited resources to address advertising violations. As a result, FDA said it “considers the type and magnitude of benefits along with the severity and likelihood of harm when making enforcement decisions,” according to the report. “FDA officials also stated that the agency encourages patient advocacy groups to report device advertisement concerns to FDA, while the agency focuses its efforts on the underlying issue in false or misleading advertisement cases, such as a company advertising its device for a medical use that has not been approved by the FDA.”

Additionally, because of FTC’s limited resources, GAO was told that FTC “considers the extent of consumer injury, financial and physical, when determining how to allocate their resources. FTC officials also told us that the small size of many offending companies can make it difficult for FTC to track and locate a company to take appropriate action. For example, someone with a small amount of capital can start a business and set up a website to sell products online, and these companies can be located anywhere in the world.”