Pfizer abandons bid to make 50-milligram Viagra available OTC in Europe.
The AP (11/20) reported, "Pfizer Inc. said Thursday it has withdrawn an application to make 50-milligram Viagra (sildenafil citrate) tablets available over the counter in Europe."
According to Bloomberg News (11/21, von Schaper), Pfizer "pulled its application with European regulators to sell a 50-milligram dose to consumers for over-the-counter use, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use said in a statement." The company "has been authorized to sell the prescription drug in the European Union since 1998 in 25-milligram, 50-milligram, and 100- milligram doses."
BBC News (11/20) reported that "the EMEA's Committee for Medicinal Products for Human Use (CHMP), had major concerns over making Viagra available over-the-counter." According to a CHMP spokeswoman, if Viagra "is available without prescription, there is no medical supervision which could delay diagnosis of underlying disease. The CHMP was particularly worried about the diagnosis of overt and silent cardiovascular disease, of which [erectile dysfunction] can be an early marker." She added that "a switch to being an over-the-counter medicine could lead to an increase in people who are not intended users taking Viagra recreationally."
The Financial Times (11/20, Jack) added that "the decision is a setback to Pfizer's efforts to boost sales in the increasingly competitive market for erectile dysfunction drugs ahead of the expiry of its patent in 2013, in the face of growing sales from two patented alternatives as well as many unregulated suppliers of counterfeits." If the company's application to the EMEA "had been approved, it would have only been the second [European Union]-wide approved switch of a prescription drug to non-prescription use. Alli (orlistat), GlaxoSmithKline's weight-loss medicine, was approved" in October. The Times noted that "the drug's growth had been restricted because many governments' national health services and health insurance funds failed to reimburse patients prescribed it." The U.K.'s Press Association (11/20) and AFP (11/20) also covered the story.
Brad Evans
