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Pfizer (NYSE: PFE) was hoping that European men could "Viva Viagra" without a doctor's OK, but that doesn't look like it's going to happen. The EU committee in charge of such things wasn't too hot on the idea of Pfizer switching one dosage level of the drug from prescription to over-the-counter use, so the drugmaker pulled its application.
Clearly, a switch would have given Pfizer a huge boost in sales. Men are often embarrassed to talk to their doctors about erectile dysfunction -- 30% of potential patients in Europe avoid the subject, according to Pfizer. This dampens sales of Viagra, Eli Lilly's (NYSE: LLY) Cialis, and Levitra, which is marketed by GlaxoSmithKline (NYSE: GSK), Schering-Plough (NYSE: SGP), and Bayer. While those men often turn to the Internet to buy the drugs, those remedies sometimes turn out to be fake. However, EU officials didn't think that was a strong enough case to move Viagra out front.
It's the Committee for Medicinal Products for Human Use (CHMP) that was reviewing Pfizer's application.
There were "some concerns regarding the proposed supply," according to Pfizer. Quoted CHMP statements, reported by the BBC, indicate that EU officials were worried that the little blue pills might fall into the hands of people who shouldn't be using them -- specifically men who shouldn't take Viagra for medical reasons. ED can be an early warning sign of cardiovascular disease, for instance. In addition, there is the potential for abuse.
While switches from prescription to over-the-counter status are fairly common in the U.S. -- Johnson & Johnson's (NYSE: JNJ) Zyrtec and AstraZeneca's (NYSE: AZN) Prilosec come to mind -- Glaxo's alli, used for weight loss, has been the only EU-wide switch to date.
Pfizer is considering how to address the EU officials' concerns and may resubmit the application, but investors shouldn't hold out hope. The EU is likely to continue to favor the safety of the minority over the awkwardness of the majority.
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