Can Technology Usher in New Era of OTCs?

As many long time readers know from earlier postings about this topic, when I step on my bathroom scale, it records my weight and sends it to my iPad.  I have a blood pressure cuff that hooks up that very same iPad and takes my pressure and the two figures are then put into a chart which I can share electronically with my physician.  With the advent of the smart phone, self-monitoring has taken on new dimensions.

Activity trackers are hitting the shelves like crazy, with some even recording your heartbeat.  I now have added to my collection a wrist band that monitors the quality of my sleep – recording how many times I wake up each night and how much of my sleep is spent in “deep sleep” as opposed to “light sleep”.

Today mobilhealthnews reports on research into non-invasive sensors that are becoming increasingly sophisticated – (“Wearables to move beyond activity, vital signs to biosensors“).

As noted here in the past, the pipeline for RX to OTC switches seems to have slowed down in recent years.  In the 1990s and early 2000s, there were significant numbers of new categories of treatments making their way from prescription to drug store shelf. There were were also some attempts that did not make it, notably statins for the treatment of high cholesterol.

Ultimately, the switch for statins failed because an important element of any switch is that the drug can be used without the “intervention of a learned intermediary” – or in other words, can be used without a doctor.  I attended these switch meetings and the panelists were not convinced that the public understood cholesterol levels well enough and would lack the ability to monitor liver functions.  While you could take an OTC pill for a runny nose and know when your runny nose was no longer runny, you could not take a pill for your cholesterol and know when you had achieved your target.

But as technology made dumb phones smart, it may also put patients in a “smarter” place as well.  What if my wrist band that now monitors my sleep and steps and heartbeat can have non-invasive sensors that track all sorts of things from my sweat and an occasional pin prick?  Can a wrist band actually do all that?  A few short years ago, getting an ECG on a phone would have been inconceivable, today – not so much.

If an OTC product such as a statin had an app and a wrist band that came with the initial purchase of the product that would then allow you to self-monitor and electronically report the results to your physician, as my scale and blood pressure cuff do now, then perhaps we could be in an era where a whole host of monitoring functions could pave the way for new classes of OTC switches.

It was only about a decade ago that the switch attempts for statins occurred, but certainly times have changed.

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