GAO Report Highlights Concerns About Device Advertising

Advertising for medical devices could confuse or harm consumers, a new report from the US Government Accountability Office (GAO) suggests.

The GAO performed the study to evaluate US Food and Drug Administration and Federal Trade Commission (FTC) oversight of direct-to-consumer (DTC) advertising for medical devices. The office has included the FDA’s oversight of medical products, including medical devices, on its list of high-risk areas since 2009.

Currently, the FDA oversees advertising for products that require agency clearance, while the FTC takes the lead on reviewing the accuracy of advertising for non-restricted devices. The two agencies coordinate as needed, the report states.

According to the GAO, the FDA took 255 enforcement actions related to medical device advertising between 2018 and 2022, while the FTC took 67 during the same period. Outside formal enforcement efforts, the FDA and FTC also issue guidance documents and hold public events to educate consumers and businesses about rules governing direct-to-consumer advertising.

The FDA told the GAO that because it has limited resources to monitor DTC ads, the agency “considers the type and magnitude of benefits along with the severity and likelihood of harm when making enforcement decisions.” The agency focuses on underlying issues in false and misleading advertising, such as if a device is being advertised for a medical use not cleared by the FDA.

Meanwhile, the FTC reviews complaints submitted by consumers about device advertising, as well as occasionally performing keyword searches for ads in areas of interest. The commission told the GAO that it typically tries to resolve an issue directly with the device firm before bringing an administrative or legal action. Resource limitations also pose a challenge for the FTC, as do small online retailers that may be based anywhere in the world.

Stakeholders Fret About False, Inadequate Ads

The GAO interviewed 11 stakeholder groups about potential effects of direct-to-consumer device advertising in preparing the report. The 11 groups included three groups each representing consumers, patients and providers, as well as two representing manufacturers.

Several of the groups said the advertising offered benefits such as consumer education. However, seven of the 11 groups identified concerns, including that the ads:

• May include false information;

• Do not always adequately explain risks;

• May harm the patient-physician relationship by “interfering with the ability to arrive at the best treatment option”;

• May increase consumer demand, possibly leading to higher prices or unnecessary device use;

• Sometimes target vulnerable populations, such as seniors and those with medical conditions; and

• Could lead to the use of devices that harm consumers.

Additionally, the stakeholders said the ease of ordering medical products online could lead to problems in the future.

Some of the participating groups also expressed specific concerns about advertising for two types of devices: Contact lenses and dental aligners.

“While their concerns were not directly related to advertising, these two groups noted that some retailers of these devices may be distributing them without complying with relevant laws and regulations or adhering to a certain standard of care, among other concerns,” the GAO wrote.