Saturday, April 30, 2016

A "Hiccup" for Digital Drugs: FDA Postpones Oral Abilify/Pill/Transmitter

One of the fiercest problems in healthcare is poor compliance with medications that actually work.  Industry is now on the edge of producing pills with tiny embedded transmitters in the tablet.  However, it won't be as fast as Otsuka and Proteus Digital Health hoped.  According to an April 26, 2016, press release, the FDA issued a complete response for their combination product with Abilify and an ingestible sensor.  The FDA asked for more information about the product "under the conditions under which it is likely to be used."  Press release here.   The issue has implications for the coordination between CDRH and CDER, the FDA's framework for digital health, and how regulatory approach the regulatory science and risk/benefit uncertainties of new generation products.   Trade press here and here.