Viagra to Switch from RX to OTC in the UK

On Tuesday, the MHRA in the UK announced its decision to make the erectile dysfunction drug Viagra available OTC in a move that the regulatory agency said it hoped would curb the purchase of the medication from unregulated websites. The UK would be the first country in the world where Viagra is legally available OTC.

Euromonitor estimates that in the first year of the drug’s availability OTC, it is likely to sell more than double the sales in the Cough, Cold, and Allergy Remedies (CCAs) category, which currently occupies the top spot in OTC sales at GBP726 million in 2016. This is the most significant RX/OTC switch in recent memory, and represents a major disruption to the global OTC market, a traditionally fairly static market.

Even more important than the changes this switch will bring to the UK market is the domino effect that is likely to occur as other major markets consider whether to make Viagra available OTC. In the US, prescriptions for erectile dysfunction drugs have fallen in recent years as the pills have become increasingly unaffordable, but this decrease in sales would be easily reversed if Viagra were switched to OTC status and would likely be the most significant disruptor to the OTC space the US has ever seen.

FDA Commissioner Scott Gottlieb has been vocal about his plans to bring generics to the market faster, and given President Trump’s repeated declarations to bring healthcare costs down through increased competition, there has been widespread speculation that the FDA might move to increase the number of RX drugs switched to OTC status, Viagra among them.