Via Alex Butler
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Pharma Industry Regulation
Stories & Insights Regarding Marketing Regulations & Guidelines
Curated by Pharma Guy
FTC regulation of the digital health space just got serious. The FTC in their recent statement says health companies need vigorous data to back up their claims.
The FTC has come down with a hammer on Lumosity — the online digital healthcompany that promised consumers their games would help reduce neurocognitive deficits. The company has settled for $2 million, and is also being imposed a $50 million judgement by the FTC. The $50 million fine is being suspended due to Lumosity’s apparently inability to pay for it.
The real story here isn’t Lumosity though — it’s the wording the FTC used in their decision to put the digital health world on notice about creating apps that promise too much without having evidence and rigorous data to back it up their claims.
"Advertisers must ... have rigorous, scientific support to substantiate claims for products that purport to prevent or treat health or disease-related conditions," said FTC.
First of all, how does Luminosity get away with not paying $50 million because it "can't afford it"? Shouldn't FTC garnish their income as would happen if you or I could not pay our fines?
Good to know that FTC supports what I have been advising pharma mHealth app developers to do for a long time: test and document that apps are effective as advertised. For more on that, read "
#mHealthEthics: A Call for Pharma to Develop Mobile Health Guiding Principles"; http://sco.lt/4w5xzd
Also, you might be interested in reading this Pharma Marketing Blog post: "If FDA were as Powerful as FTC"; http://bit.ly/FTCvFDA