November 20, 2008

-         Pfizer, Inc. –

On November, 20, 2008, Pfizer officially announced about the withdrawal of application on switching Viagra 50 mg from prescription status to non-prescription on the territory of the European Union. The news appeared on the official web-site of the U.S.-based world-known pharmaceutical company.

Since the introduction of Viagra in 1998, the medication became a blockbuster drug against erectile dysfunction. During a decade Viagra has been prescribed to over 35 millions men around the globe. To make the medication even more affordable and easier to get for those, who suffer from impotence, Pfizer planned to make the medication available over-the-counter in Europe. The over-the-counter or OTC status of the medication means that it can be bought in any pharmacy without doctor’s prescription.

However, after reconsidering all the potential concerns, which may arise in association with non-prescription Viagra, and taking into account the comments from the EMEA’s Committee for Medicinal Products for Human Use (CHMP), Pfizer decided to withdraw its application for OTC Viagra supply in EU.

In its press-release Pfizer said that the company “believes that Viagra 50 mg is a suitable candidate for non-prescription supply through pharmacists in the EU”. Besides, Viagra is said to comply with all the requirements, which are necessary for changing the status of the medicinal product to non-prescription. But in that case the question arises: what made Pfizer to voluntarily withdraw its application from the EU health regulatory authorities?

On one hand, the OTC status of the medication could definitely offer many benefits to men with erectile dysfunction. Many men are said to go untreated because of personal embarrassment associated with talking to doctor about such intimate health concern, as impotence. Besides, making Viagra available without prescription could significantly reduce the amount of the medication sold illegally over the internet from unknown sources.

On the other hand, medical experts note that granting OTC status to Viagra will take away the opportunity of doctors to identify some underlying and often “silent” health disorders, such as diabetes and cardiovascular problems.

The point is that recent researches proved impotence may be among the earliest signs of some underlying cardiovascular diseases, which develop silently with no symptoms. When a patient visits his doctor to receive a prescription for ED medication, the doctor gets the opportunity to fully examine his patient and identify those underlying health disorders, and, consequently, start treating them at earlier stages. With non-prescription Viagra, people will not need to visit doctors to get the prescription for this medication, and thus the opportunity of early detection of cardiovascular threats can be missed. That is said to be the major factor, which made Pfizer to recall its application for non-prescription Viagra.

So, currently Viagra will remain available to patients by prescription from their doctors. However, it looks like the availability of non-prescription Viagra in the future is not excluded. Rory O’Connor, Pfizer vice president of Medical and Regulatory Affairs, said “We will continue to work with regulators in Europe to improve the availability of our medicines to patients and physicians and the benefits they get from our therapies.” 

Nick

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External resources
http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp?rssUrl=ht...
http://news.bbc.co.uk/2/hi/health/7739420.stm
http://news.bbc.co.uk/2/hi/health/6254813.stm
http://www.medicalnewstoday.com/articles/130201.php

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