telehealth

Those of us who spend our days at the intersection of law and advertising of health products generally accept that the prescription drug world is a universe unto itself, overseen by the FDA pursuant to the Prescription Drug Marketing Act. As prescription drug companies have increased their direct-to-consumer outreach through social media, native advertising, and health information platforms, questions have arisen as to the role that the NAD might play in regulating these advertisements.  For those who are unfamiliar, the NAD is the National Advertising Division of the Better Business Bureau.  It is an industry self-regulatory body that is charged with hearing and rendering decisions in advertising disputes, typically among competitors.  It is commonly used amongst advertisers of consumer-directed products and services.  It is not commonly used amongst prescription drug advertisers and, until recently, many likely assumed that NAD did not have jurisdiction to hear prescription drug advertising challenges.

A relatively recent NAD decision makes clear that that body believes that it has jurisdiction over prescription product advertising, however. Late last year, the NAD evaluated advertising by Synergy Pharmaceuticals for its Trulance product, which is prescribed for chronic idiopathic constipation.  Allergan, maker of a competing product, challenged the advertising on the basis that it included false implied superiority claims, expressly false superiority claims, and undisclosed native advertising in the form of a waiting room pamphlet that allegedly was positioned as independent and impartial patient education material. 
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The FTC announced late last week that it resolved its case against the final defendant, Avrom Lasarow, in the “Melanoma Detective” app matters.  The FTC alleged that claims that the apps could detect and diagnose melanoma in its early stages were not supported by competent and reliable scientific evidence.  As we discussed here, the

The Federal Trade Commission announced this week that it has reached settlements with two marketers for “deceptively claiming their mobile apps could detect melanoma, even in its early stages.” MelApp and Mole Detective claim to have the ability to accurately screen for a mole’s analyzed melanoma risk despite the absence of clinical testing. The FTC

The annual International Consumer Electronics Show (CES), held each year in early January, is a showcase for the latest gadgetry trends.  The recently-concluded CES 2015 featured innovation in a variety of forms, not the least of which are products with a health-related focus.  From the FitBit to track steps to the Quitbit to track progress in quitting smoking, the number of products recording consumer behavior continues to proliferate.

Techies and ordinary consumers aren’t the only ones interested in all things electronic, however.  Numerous government agencies have jurisdiction over these products depending on their functionality, including the Federal Trade Commission (FTC), the Food and Drug Administration (FDA), and the Federal Communications Commission (FCC).  A few products featured at this year’s CES demonstrate this intra-agency overlap.

For example, the “Breathometer Breeze Breathalyzer” features the following claims:  it can detect blood alcohol levels with the same degree of accuracy as policy breathalyzers, tell consumers when their blood alcohol content will be 0.0, and has a “home safe” function that allows consumers to call a car service or friend to help them get home safely. The product purportedly is a Class I medical device that can connect to smartphone apps via Bluetooth.


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