I speculated before at the slim chance that the FDA would have even the first idea about how to regulate mHealth but with the 30 page Mobile Medical Applications Draft Guidance (issued July 21) now out I think it’s quite safe to say they’ve removed all doubt that they would have the first idea about the challenges.
As the Department of Justice makes Google forfeit $500 million for using its AdWords program to market prescription drug sales by canadian online pharmacies to US residents I think it’s worth reflecting on a few things:
1) The FDA guidance suggests that the “android market” and “iTunes store” are examples of “distributors” (ie. not subject to regulation)
2) The FDA Guidance document doesn’t even mention in-app, appstore, location based or mobile web advertising
3) Acquired by Google for $750 million, AdMob reported more than 2 billion ad requests per day to more than 100 million unique devices in Jan 2010 (up 300% over 2009) and Google reported $130 million in 2010 revenues from Android in app adverts (+ another $720m from other types of mobile advertising)
If none of that gets you thinking that completely ignoring mobile advertising represents a very serious oversight from the FDA here’s Google’s vision for it’s mobile payment solution (as shared by Osama Bedier, VP of Patments, Google):