The pharmaceutical industry has to police itself with regard to development of medical apps. There has to be good documentation of the testing of apps to ensure their correctness.
That’s the summary of my point of view (POV) regarding the pharma HOTSPOT topic: “Should Pharma reconsider its mobile application approach with FDA guidance looming?” See the annotated video below:
A “counterpoint” was offered by Dr. Chetan Vijayvergia, PhD, Director of Medical Strategy, Ignite Health, on Ignite Health’s Pharma HOTSPOT web site. Dr. Vijayvergia’s point was “The apps that are currently being created in the Pharma space don’t have a predicate in the FDA database. Pharma needs to reconsider the mobile approach to actively help the FDA shape industry guidance” (see here).
Vijayvergia contends that the current FDA draft guidance for MMAs “casts a very wide net” and if pharma app developers are not careful, their apps can get “dinged as an MMA [mobile medical application]” and be subject to regulation as a medical device.
The fear that FDA is casting too “wide a net” over MMAs was first expressed by PhRMA (see “FDA Mobile Regulatory Fear Mongering by PhRMA“). IMHO, the FDA was pretty clear about staying away from most health-related apps aimed at consumers such as diet apps, etc.
The Best Defense Against Zealous FDA Regulation is Self-Regulation!
In addition to offering FDA its POV regarding what is and what is not a MMA subject to medical device regulation, the pharma industry, IMHO, should begin policing itself to develop MMAs that comply with standards such as Happtique’s App Certification Program; listen to this podcast regarding that:
You may also enjoy reading these previous posts regarding pharma mobile medical apps:
- FDA Issues Long-Awaited Guidance – for Mobile Medical Apps. Janssen, Look Out!
- Be Aware of What’s Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story
- The Problem with Unregulated “Calculator” Apps for Physicians: Buggy Software!