FDA Approves Proteus “Digital Medicines”

The FDA recently approved the Proteus system for creating digital medicines.  What does this mean?  It means that in the future the pill you swallow could have a digital tracker that confirms that you really did take your medication.

This is a fascinating development especially as adherence continues to be a focus in quality metrics.  And, with the recent study by CVS Caremark, you now have two critical reasons that adherence should be a part of any health intervention program:

1. Adherence is proven in several conditions to directly lower overall medical costs; and

2. Adherence is shown to improve absenteeism.

BUT, does that justify a device in your pills.  Not alone, but if you look at the recent Express Scripts’ study (that was unfortunately buried in their drug trend report), you’ll see that there’s a material gap between how adherent patients think they are and their real adherence.  That might justify a device.

The big questions will be:

1. What will the cost of the device be?
2. How easy will it be to use?  (Right now, you’ll need patches and connectivity to a mobile device.)
3. How easy will it be to manufacturer it into the pill?  (Right now, you take a second pill with the device.)
4. Will integrated manufacturing change the pill or the production line requiring any capital investments by the manufacturer?
5. How many drugs will this be cost justified by?
6. Will we really want to be monitored that closely or will this seem too big brotherish?

This story (and others like it) will continue to come out.  It’s an interesting one.