Safe-Use? It’s All About The Base

The joke inside the FDA is that the Brief Summary is like the Holy Roman Empire – neither brief nor a summary. Funny for the FDA – and an important jump-starter for a serious question – how can safety information be more user-friendly . To quote one of my favorite doctors, Dr. Seuss, “Sometimes the questions are complicated and the answers are simple." If it’s all about safe-use, to paraphrase some pop culture, it’s all about the base for both the FDA and pharmaceutical marketers.

The theory behind safe-use is that the best way to make any drug safer, it to ensure it is used as directed. That means putting that information in places and formats that are most accessible to patients. And in 2015 that means mobile apps. New user data from Mobile Health Library (MHL) confirms that, when Important Safety Information (ISI) is made mobile-friendly, it’s regularly accessed by on-treatment patients.

Consider one year’s worth of data for MHL’s patient support app for generic Exemestane. Of all the engagement activities available to the user, “Side Effects & Safety” rank first (at 28%), followed by “Savings & Refills" (16%), “About Condition" (15%), “About Exemestane” (14%), and “Dosing Reminder” (13%).  And the safe-use numbers for branded medicines are even higher. For one medicine (a branded epilepsy treatment), patients are accessing the Med Guide at 90%+ rates.



If it’s about giving the patients what they want – then it needs to be about giving them safety information in the ways they want it. When it comes to safety, it’s time for both the FDA and Big Pharma to start saying “App-y New Year.”

Peter J. Pitts

 Chief Regulatory Officer