Once again, Republican Federal Trade Commissioner Maureen Ohlhausen has taken her colleagues in the Democratic majority to task for overregulating advertising – particularly health-related – to consumers’ detriment. Previously, she parted ways on issues of claim interpretation and substantiation in POM Wonderful, where, as I’ve written (POM Wonderful, Round 3: ‘Disclosure’ vs. ‘Outright Suppression,’ DRMA Voice, March 2013), she felt the FTC exceeded its authority by finding “implied” disease treatment claims based on its own facial reading of POM’s ads rather than extrinsic evidence showing that consumers also perceived the claims, and by imposing an overly stringent substantiation requirement – two randomized clinical trials (RCTs).
Her policy differences over these issues have flared up again in a dissent to the issuance of complaints and settlements in FTC v. Avi Lasarow and In re Health Discovery Corporation, which address the marketing of a family of apps dubbed the “Mole Detective” and “Mel App” that are intended to aid consumers in detecting the possible presence of melanoma. Using one of these apps, the consumer photographs a mole with a smartphone camera and inputs other information about the mole. Through the use of algorithms, the apps then are supposed to determine the mole’s melanoma risk to be low, medium or high. The FTC’s complaint alleges that the company deceived consumers by claiming, without adequate scientific evidence, that the apps accurately analyzed melanoma risk and could assess such risk at an early stage.
Claims for the Mel App included that it used “patent protected state-of-the art mathematical algorithms and image-based pattern recognition technology to analyze the uploaded image [of a skin lesion],” to “provide a risk analysis of the uploaded picture being a melanoma,” and to “assist in the early detection of melanoma.” Claims for the Mole Detective included that it “is the first and only app to calculate symptoms of melanoma right on the phone,” could “analyze your mole using the dermatologist ABCDE method and give you a risk factor based on the symptoms your mole may or may not be showing,” could “increase the chance of detecting skin cancer in early stages,” and could “save lives through the early detection of potentially fatal melanoma.”
The settlements ban the companies and their principals from making any claim that a device “detects or diagnoses melanoma or risk factors of melanoma,” or increases users’ “chances of detecting melanoma in early stages,” unless the claim is supported by “competent and reliable scientific evidence,” defined as controlled, blinded human clinical testing.
In her dissent, Ohlhausen argues that the standard of controlled human clinical testing, the highest level of substantiation, applies to an overly broad range of claims, and does so as the result of a misguided approach to interpreting the advertising messages for the Mel App and Mole Detective. In a statement defending the settlement, Chairperson Edith Ramirez and Commissioner Julie Brill assert that it is appropriate to apply this standard to any claim that these or similar devices accurately analyze moles for symptoms of melanoma and increase the chance of detecting skin cancer in its early stages. Ohlhausen disagrees, contending that “accuracy” is relative and that the highest level of substantiation should be required only for the most powerful claim, which would be a promise of maximum detection capability.
In this context, the highest level of capability would be dermatologist-level accuracy, a claim she says was not expressly made in advertising for the Mel App and Mole Detective, and one she doubts was even implied. The ads never claimed that the apps were a substitute for a dermatologist exam, but rather described the apps as tools to enhance self-assessment in conjunction with visits to dermatologists, and emphasized the importance of dermatologist visits. Without extrinsic evidence, which she would have required – empirical proof of the messages reasonable consumers actually took away – the FTC could not know for sure whether the ads were implying the highest level of accuracy, equal or even superior to a dermatology exam, or simply claiming that the Mel App and Mole Detective provided greater accuracy than unaided self-assessment, a lower level of capability to which Ohlhausen would apply a lower level of substantiation. Over her dissent, however, the Commission voted to apply the highest level of substantiation – controlled human clinical testing – to either.
The conclusion to Ohlhausen’s dissent sums up her concerns over this approach thusly:
Health-related apps have enormous potential to improve access to health information for underserved populations and to enable individuals to monitor more effectively their own well being, thereby improving health outcomes. Health-related apps need not be as accurate as professional care to provide significant value for many consumers. The Commission should not subject such apps to overly stringent substantiation requirements, so long as developers adequately convey the limitations of their products. In particular, the Commission should be very wary of concluding that consumers interpret marketing for health-related apps as claiming that those apps substitute for professional medical care, unless we can point to express claims, clearly implied claims, or extrinsic evidence. If the Commission continues to adopt such conclusions without any evidence of consumers’ actual interpretations, and thus requires a very high level of substantiation for health-related apps, we are likely to chill innovation in such apps, limit the potential benefits of this innovation, and ultimately make consumers worse off.
With the announced resignation of her Republican colleague, Commissioner Joshua Wright, Ohlhausen is now the sole voice of restraint in this FTC’s relentless march to subject the widest possible berth of health-related claims to the requirement of controlled human clinical trials, rather than the more flexible, traditional standard of “competent and reliable scientific evidence” as determined by a consensus of experts for a particular product category. The FTC, a non-scientific agency, is now aggressively usurping that role, deeming itself the “expert” and imposing a single, one-size-fits-all standard on which there is no clear scientific consensus outside the world of pharmaceutical testing. Will consumers be worse off as a result? Ohlhausen certainly thinks so.