Health products are increasingly moving from the realm of the medical professional to the consumer. Direct-to-consumer (DTC) versions of teeth alignment kits, genetic tests, hearing aids, heart-rhythm monitors, neurostimulation devices, and mental health tools are already on the market, causing professional organizations of dentists, geneticists, audiologists, cardiologists, neurologists, and psychiatrists to grapple with challenges to their authority and practice.
So far, questions about safe and appropriate marketing and use have reverberated mainly within individual professional domains. We believe that thinking about these products as part of a larger problem can yield valuable insights.
Since 1976, the Food and Drug Administration has acted as a gatekeeper for companies bringing medical devices to the market. Today, however, many companies bypass the FDA by marketing quasi-medical products directly to consumers for “wellness” or “lifestyle” purposes. The technology or technique is often still experimental, with limited evidence about safety and effectiveness. This situation leaves researchers and health professionals concerned about unvalidated products being offered directly to the public, while forcing consumers to navigate ambiguous — and sometimes misleading — claims.
Those with concerns about specific devices can appeal to regulatory authorities such as the FDA and the Federal Trade Commission, which has the authority to take action for misleading advertising. But the regulatory frameworks of the FDA and FTC are poorly suited to address a fast-paced, ever-changing landscape of startups marketing devices that blur the line between medical and consumer products. Although the FDA is actively piloting new approaches, such as its digital health software precertification program, we see at least five other ways to address the challenges these products raise.
First, alternative regulatory solutions that are better matched to the current direct-to-consumer health landscape are needed. One lean, nimble model of third-party regulation is Truth in Advertising (TINA), a nonprofit, privately funded organization that monitors deceptive advertising. With a full-time staff of just five individuals, TINA strategically uses the media to put pressure on companies making false claims in their advertising. If that fails, TINA files complaints with federal and state regulators. In this way, TINA acts as a supplement to the FTC and state consumer protection bureaus. It does not act outside of the law, but derives its authority precisely because it can appeal to existing consumer protection regulations. Even minimal additional funding for an organization like TINA, most likely from public-interest foundations, could prove beneficial in the realm of direct-to-consumer health products.
Second, DTC health products should be reconceptualized as primarily presenting problems of information rather than of regulation. In this reframing, direct-to-consumer health products are an issue that can be approached in much the same way as a public health information campaign, with the aim of increasing consumer understanding of the evidence, risks, and benefits. Casting the problem as informational instead of regulatory also reframes the role of the media: In the old model, the media were peripheral players in a battle between manufacturers and regulators. In the new model, the media play an active role in increasing consumer understanding, combating misinformation, and shaping public perception about direct-to-consumer health products.
Third, public information campaigns need to be waged with digital, not analog, tools. Watered-down statements from government agencies and patient pamphlets have little impact in today’s world, where information wars are waged on digital battlefields like Twitter, Instagram, YouTube, and online forums. Effective outreach requires compelling video, imagery, and memes — along with help from social media influencers.
Fourth, in order to carry out meaningful public information campaigns, we need more research on the validity, safety, and effectiveness of DTC health products, on how consumers decide to obtain them, and on how they use these products. Gathering these data will make it easier to effectively target public information campaigns, but will also inform professional groups, regulators, clinicians, and consumers.
Fifth, health professionals must become more informed about the direct-to-consumer health products in their respective fields. Rather than merely dismissing such products as invalid or irrelevant — which may discourage patients from talking about them — health professionals must recognize that their patients will have heard about these products and that they may present affordable, attractive options. Openness to realistic, honest conversations about the risk/benefit trade-offs of DTC health products will help health professionals guide their patients in making optimal choices for their health care.
We’ve entered a new world in which direct-to-consumer health products offer greater patient autonomy while traditional methods of regulation no longer suffice. Instead of relying exclusively on proactive governance by regulatory agencies, we need oversight of these products that accepts their presence in the health care landscape, emphasizes the need to both acquire and disseminate accurate information, and leverages digital tools for effective outreach.
Anna Wexler, Ph.D., is an assistant professor of medical ethics in the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine. Steven Joffe, M.D., is a professor of medical ethics and health policy and chief of the Division of Medical Ethics at the Perelman School.