The world of medical devices is expanding. In the eyes of the consumer, medical devices are often lumped in with biotechnology and pharmaceuticals. The average medical products consumer does not distinguish between a drug, a face cream or a nail clipper. There is little consumer education, but if you watch TV, Stryker will recommend that you tell your surgeon to use their hip replacement.
We are in the information age, so watch out, device companies. We are also in a heightened regulatory environment, in part due to the powers that be in Washington and in part because of the bad boys on Wall Street, whose scandals have spilled over to every other industry, especially those money-grabbing medical device companies. Medical device makers, look sharp, because the Feds are coming for you. They may just change the classification of your device and make it harder to raise funds to get your now-PMA, once-510(k) product to the market. Or they might look at your marketing materials and website and trade show infomercials and from there begin the hunt for what looks like off-label promotion.
The Food & Drug Administration has regulatory authority over the labeling of all medical devices. But FDA’s regulation of medical device advertising is limited to a subset of medical devices, which are expressly designated as such in a PMA approval order. The Federal Trade Commission regulates the advertising, as opposed to the labeling, of most medical devices under sections 12-15 of the Federal Trade Commission Act, which prohibit false or misleading advertising of certain products that FDA regulates. Sections 502(q) and 502(r) of the FD&C Act authorize FDA to regulate the advertising of certain devices, which are known as restricted devices. Section 502(r) also states that restricted devices are not subject to sections 12-15 of the Federal Trade Commission Act.
Thus, FDA regulates the advertising of restricted medical devices, while the FTC regulates the advertising of non-restricted devices. Are you confused yet?
The agencies claim they have a joint task force and are working more closely than ever to step up enforcement and compliance efforts. This is especially true of medical devices taking the direct-to-consumer approach. (The in vitro diagnostics industry, regulated as a medical device, which we will discuss in another series, has its own maze to navigate in relation to regulatory actions.)
At this stage, medical devices have no statutory requirement that restricted device advertisements be submitted to FDA for review prior to dissemination or broadcast. The main difference occurs at the time of dissemination or broadcast. Medical device companies are not required to submit to FDA copies of promotional materials for medical devices, including broadcast advertisements, at the time of dissemination. In contrast to the pharmaceutical industry, FDA’s device regulations do not contain specific requirements regarding the content of advertisements for restricted medical devices. Regulation of restricted device advertising thus stems directly from the statute, sections 502(q) and (r), under which a restricted device is misbranded if its advertising is false or misleading in any particular or does not contain a brief statement of the device’s intended use and relevant warnings, precautions, side effects and contraindications. Device manufacturers have a lot to offer the public, of course, through the physician intermediary.
The FDA regulates most devices under the “intended for use” or “intended to” prongs of the definition of a device. The FDA looks at many types of promotional materials in determining evidence of the device’s “intended use,” including websites, sales talks, brochures, advertising, training materials, demonstrations and trade show displays. User training is considered “labeling.” It’s quite interesting to note that much of the FDA’s enforcement actions initiate after trade shows. So watch what you say and do on those circuits.
Dr. Daniel Schultz, director of the Center for Devices and Radiological Health, told Congress (PDF) that the “FDA is committed to ensuring that medical device promotion and advertising, including DTC advertising, is truthful and not misleading, that it helps consumers make better-informed choices about their health and healthcare and that it helps prevent potential misconceptions about benefits and risks of the advertised treatment.”
I am a public health advocate and lawyer, but how much help does the FDA’s enforcement really give the consumer?
Proponents of DTC promotion of medical products argue that it has educational value and will improve the physician-patient relationship, increase patient compliance with therapy and recommended physician visits and generally satisfy consumer interest in obtaining desired medical product information.
Opponents contend that consumers do not have the expertise to accurately evaluate and comprehend such advertising, that physicians will feel pressure to recommend treatment that is not needed and that DTC promotion will damage the physician-patient relationship and increase the price of medical products. We will have to see how health reform will enter into this debate, but either way, the device industry needs to watch carefully in order to NOT be considered part of the pharmaceutical industry in any sweeping reforms coming out of Congress.
