Pfizer, the manufacturers of Viagra, have withdrawn an application that would have allowed the drug to be sold in 50 miligram doses over the counter. The application was terminated after the European Medicines Agency raised concerns over the safety of the proposal.
The company had hoped that with the drug more readily available, some of the stigma felt by those suffering from erectile dysfunction might be lessened. The failure of the application is a severe setback for Pfizer, whose sales have been hit not only by the growing popularity of two patented alternative drugs but by the large numbers of counterfeit pills being offered on the internet. Pfizer had hoped through advertising and increased revenues from non-prescription sales to regain losses wrought by the internet counterfeiters and the rival products. Though their sales have gone up by 6% over the past year, growth has not been as large as might be expected, as in many countries those being prescribed Viagra will not be reimbursed by their insurance companies and it is only available to a very limited number of patients on the National Health Service in the UK. Most patients acquiring the drug legally pay for it privately, with Pfizer estimating that 30% of men who seek treatment for erectile dysfunction leave the healthcare system entirely.
The European Medicines Agency however was alarmed that with no proper medical history taken, doctors would not have the chance to diagnose any underlying medical conditions causing the patients’ erectile dysfunction. In a statement, their spokesman said they were "particularly worried about the diagnosis of overt and silent cardiovascular disease, of which ED can be an early marker”. She also pointed to the risk of misuse due to excessively complicated information on the product, as well as a possible increase in those purchasing the drug for recreational use.