Viagra Sags After European Regulator Nixes O-T-C Plan

24 November 2008

BRUSSELS: The [marketing] spirit may have been willing but the [regulatory] flesh was weak when the European Medicines Agency last week rejected Pfizer's application to vend its top-selling erectile dysfunction drug Viagra via retail pharmacies without a doctor's prescription.

Pfizer, the galaxy's largest pharmaceutical firm, has garnered a staggering $15 billion (€11.97bn; £10.12bn) in Viagra sales to more than 35 million men worldwide since its launch ten years ago.

But the pharma money-machine was denied the opportunity to make several billion more from non-prescription sales when the EMA denied permission on safety grounds.

The agency cited concerns that prescription-less sales might lead to inappropriate use, with patients obtaining the drug over the counter without an opportunity for doctors to diagnose the medical conditions that cause erectile dysfunction.

EMA also feared that Viagra would be purchased by younger people for recreational use.

Viagra sales have sagged since other erectile brands such as GlaxoSmithKline's Levitra and Eli Lilly's Cialis hit the market in recent years. Moreover it is under attack from illicit pirated versions. 

On learning the EMA's decision, Pfizer bit its lip and declared its top priority to be patient health and safety. "We will continue to work with regulators to improve the availability of our medicines to patients and physicians and the benefit they get from our therapies," said a spokeswoman.

Data sourced from Financial Times; additional content by WARC staff