What Does an Evolving OTC Environment Mean?

Once upon a time, it was quite common for drugs to switch their status from prescription to over-the-counter (OTC) making them much more accessible to people by means of ability to purchase and cost.  Allergy medications and heartburn treatments saw many such switches during the 1990s and into the early 2000s.  And while switches continued, the pace of the pipeline slowed significantly. And as treatments become more complex in their nature and administration, there are fewer candidates for switching.

The switch of Prilosec to OTC status was significant for many reasons, other than the size of the market, as it represented a treatment that addressed not a symptom (I have a headache – pill=better) but a condition (heartburn bothers me = pill over the course of time).  Could consumers understand the difference?  Apparently, but at the time, there was debate.

The standard that is looked for in a switch is candidate rests on whether a person can read and understand the label and use the product without the intervention of a “learned intermediary” (your doctor, physician assistant or nurse practitioner).

Statins have tried and failed to make the switch from RX to OTC. Two primary things held them back.  First, one’s cholesterol level is not something one can diagnose on one’s own – hence the need for the learned intermediary.  Second, a patient on statin therapy is supposed to have blood tests every six months to assess whether or not there is any liver function issue.

Recently, two things are in the works that could change the picture for statins from a regulatory perspective.  First, FDA has scheduled a meeting for later this month on the future of OTCs. And second, last week FDA indicated that the label for statins could be changed to remove the requirement for liver monitoring for people taking statins.

The removal of the monitoring requirement for statins addresses in part the second of the two obstacles for statins.  Now all we need is an app for one’s i-Pad that gets a cholesterol reading – or an app that records one’s cholesterol level from the physician so that when one goes to pick up an OTC statin, one has information that can be discussed with a pharmacist, perhaps under a new paradigm arrived at during FDA’s upcoming meeting.

Granted along with the new label change, there have also been some concerns expressed about statins.  How it plays out is unclear, but one thing that is clear is that between improved technologies and an altered regulatory framework, consumers may get more choices in self treatment in the future – though there is bound to be debate.

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