The apps targeted by the FTC make medical claims, such as the ability to diagnose cancer and treat attention deficit hyperactivity disorder (ADHD), which would put the programs in the higher-risk category and make them fair game for FDA regulation, as described in the mobile medical apps guidance. However, the Agency (FDA) in charge of monitoring advertising is waging the battles. “Although the FDA has emphasized that it intends to continue to regulate higher risk mobile apps that meet the definition of ‘device,’ it appears to have deferred to the FTC in the recent cases discussed,” Morgan Lewis attorneys wrote.
The law firm Morgan Lewis points to three FTC actions taken this year. In January, the FTC charged that Focus Education violated the Federal Trade Commission Act by making unsubstantiated claims that its ifocus system “permanently improves children’s focus, memory, attention, behavior, and/or school performance, including in children with ADHD.”
“The proposed order prohibits the company and its principals from making unsubstantiated claims about the benefits, performance, or efficacy of products or services that supposedly alter the brain’s structure or function; improve cognitive abilities, behavior, or academic performance; or treat or reduce the symptoms of cognitive disorders, including ADHD,” the brief says.
In February, two melanoma detection apps received scrutiny. Melapp’s marketer claimed that its smartphone diagnostic device uses “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 “assist in the early detection of melanoma,” according to the brief.
Meanwhile, Mole Detective’s marketer said it “is the first and only app to calculate symptoms of melanoma right on the phone” and that it 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,” “increase the chance of detecting skin cancer in early stages,” and “save lives through the early detection of potentially fatal melanoma by helping you check and track your moles,” the brief says.
The promoter of Melapp paid a fine of $17,063, while the promoter of Mole Detective paid $3,930. The settlement with the FTC bars them from making claims that the apps can accurately detect or diagnose symptoms of melanoma.
REFERENCE: Fierce Medical Devices; 27 MAR 2015; Varun Saxena