Are OTCs Just O – as in Over?

J0185152 In the 1990s the number of drugs that switched from Rx status to Over-the-Counter (OTC) was quite high and the Non-prescription Drugs Advisory Committee (NDAC) was having a lot of meetings to consider switches of several heartburn remedies, allergy medications – even to the point of having third party payers petition the FDA for an Rx to OTC switch of a product.  

However, then the pipeline sort of petered out.  There were some interesting attempts, most notably the attempts to switch some statins to OTC status – which ultimately failed due to some safety concerns, but also because patients do not have the ability to self monitor cholesterol levels.  A fundamental criteria for switching is that the drug can be taken without the existence of a "learned intermediary" – in other words, the doctor.  The other interesting attempt was to switch an anti-viral treatment for herpes, which failed when the advisory committee could not be convinced that a person could self-diagnose the condition.  

Medicines that are left on the Rx side today may simply involve too much complexity in use, monitoring or diagnosis of condition to leave many strong candidates for switching, at least not switching into new ground-breaking territory.  And not only has the pipeline diminished, but some of the drugs that have been switched have, once OTC, suddenly found themselves re-examined for safety issues.   In June 2009, the FDA warned that Zicam, a cold remedy, might cause a loss of the sense of smell.  And in August, the agency stated that reports were being reviewed for issues related to liver-related adverse events for patients using orlistat, sold OTC as Alli.

While the 1990s were a time when consumers were pushing for greater access to new treatments, both Rx and OTC, the 00's have brought with them a decade of caution and risk aversion that now means that for all drugs, the examination of risk is doubly what it was a decade ago.  That doesn't spell a gushing OTC pipeline in the near future.  
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One Response to Are OTCs Just O – as in Over?

  1. ted says:

    I believe Zicam is not an OTC switch. It is technically not a pharmaceutical, it’s a homeopathic “remedy” and as such is not regulated in any real way by the FDA. They can move to warn or remove if clear safety issues become evident, but the FDA does not approve these, and they do not need to demonstrate efficacy. This is a huge loophole and a clear danger to the public. It’s also a giant scam, and a multi-billion dollar industry.
    Thought you’d want to know.