Pfizer Pulls Back On European Viagra Switch As Questions Linger
This article was originally published in The Tan Sheet
Executive Summary
Pfizer withdraws its application to switch Viagra 50 mg from prescription to nonprescription status through the European Medicines Agency's centralized process, the company said Nov. 20
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Pfizer in talks to launch consumer ED product
Undeterred by challenges to switching Viagra (sildenafil), Pfizer is reportedly developing a new Viagra-like erectile dysfunction product in the U.K. that it hopes to sell directly to consumers, according to 1Campaign, an advertising industry publication. A Pfizer spokeswoman would not confirm the potential launch, but noted in an e-mail that the firm "routinely evaluates" drug delivery and formulations. The New York-based firm withdrew its centralized switch application in the EU for Viagra November 2008 for further evaluation after regulators expressed health safety concerns (2"The Tan Sheet" Nov. 24, 2009). Health concerns include negative interactions with nitrates for blood pressure. According to Campaign, Pfizer wants to launch the product in 2011. It reports the product includes the same ingredient as Viagra, but is modified slightly. U.K. pharmacy chain Alliance Boots already sells Rx Viagra without a prescription through pharmacists at 29 stores under the country's Quality Care Commission regulations. A pilot Boots launched in 2007 showed pharmacists effectively could determine whether customers should use Viagra and that the program would prevent abuse by consumers trying to buy the drug for recreational purposes, the chain said in June 2009. Customers must register for the service with Boots and agree to have their doctors notified that they are buying Viagra (3"The Tan Sheet" June 29, 2009)
Centralized Switch Can Be Improved Via Practice, Practical Strategy
Over-the-counter drug makers can advance the EU centralized switch process by keeping the applications coming so that health authorities can "learn by doing," says Patrick Le Courtois, head of the human medicines development and evaluation unit at the European Medicines Agency