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Viagra Without a Prescription? A Pharma Insider Explores OTC Possibilities

By Jim Edwards
April 12, 2010

Since 2007, there has been speculation that an erectile dysfunction drug - Pfizer's Viagra, for instance - may eventually become available from pharmacies without a prescription. Such a move would make thedrug available to a larger range of patients, including those too embarrassed to discuss the condition with their doctor, younger men who don't regard themselves as candidates for a full-blown prescription, and men who feel they might only need the drug for occasional use. Any company that marketed an "over-the-counter" version of one of the leading E.D. drugs would likely see a significant increase in sales, if only from curious new consumers sampling the drug on a whim.

While a non-prescription version of Viagra, Bayer's Levitra or Eli Lilly's Cialis is probably years away (there are significant legal and regulatory hurdles for companies to cross before such a pill becomes available at your local drug store), it nonetheless remains a possibility that cannot be ruled out. Pfizer has experimented with over-the-counter Viagra sales in the United Kingdom, and an experimental drug named Zoraxel, being developed by Rexahn Pharmaceuticals, could in theory pave the way for non-prescription E.D. in the future.

The Current Market

Currently, no E.D. drugs are available without a prescription. The U.S. FDA requires a prescription because E.D. is a medical condition best diagnosed by a doctor. There are many different potential causes of E.D., which may be a symptom of a more serious underlying condition, such as high blood pressure, diabetes or heart failure. If used wrongly, the drugs currently on the market can kill you - E.D. drugs combined with nitrates taken for blood pressure can drastically lower your blood pressure and trigger a heart attack.

However, that is not a complete bar to OTC status. Broadly, the FDA allows drugs to become available without a prescription if they meet two criteria: First, that the condition can be accurately diagnosed by the consumer and second, that the drug can be used safely without a doctor's supervision. Clearly, consumers can accurately judge for themselves whether they have E.D., so the first hurdle is not a problem. The safety issue, however, is more difficult.

The Precedent

In the U.K., authorities in 2007 briefly allowed Pfizer to sell Viagra through certain branches of the Boots pharmacy chain in an experiment to see whether the drug could be safely sold without prescription. Consumers had to present the pharmacist with a medical history, including blood pressure, cholesterol and glucose levels, and in return the chemist supplied them with four pills. If they needed more they were referred to a doctor. But the experiment was stopped when the European Medicines Authority (EMEA) stepped in. EMEA's Committee for Medicinal Products for Human Use said: "If the drug 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 E.D. can be an early marker."

Pfizer has argued that such a scheme would be likely to bring more men into contact with medical professionals. Millions of men are currently circumventing doctors or pharmacists when seeking E.D. medicines, and exposing themselves to the risks of medicines from unregulated sources that may be counterfeit or dangerous. The company has not closed the door on its efforts to make Viagra more widely available. It said: "Since its introduction in 1998, there has been ongoing speculation about Viagra's alternate uses and delivery mechanism. As with many of our medicines, Pfizer routinely evaluates ways to improve the delivery and formulation of our medicines to bring the greatest value to patients and healthcare professionals and continues to do so." The company is reported to be preparing a new version of Viagra that may qualify for OTC status in the U.K. In general, medicines that are approved in Europe tend to be approved the same way in the U.S.

The FDA and the Future

The issue in the U.K. trial is the same issue that would concern the FDA in the U.S.: If an E.D. drug was available without doctor supervision, patients may not get needed health advice or, worse, they may not read or understand the warnings that accompany such drugs. Wall Street analysts at Zacks Independent Research and Natexis Bleichroeder believe there is almost no chance of the FDA approving Viagra without a prescription for OTC sales because patients cannot be trusted to read the drug label properly and because Viagra can be abused or misused.

Another possibility is the arrival of Rexahn's Zoraxel E.D. drug. Unlike Viagra et al, which affect the cardiovascular system, Zoraxel is a clavulanic acid compound that affects the central nervous system, and could potentially be safer to use. But Zoraxel is still in testing and is years away from approval or launch.

Non-prescription E.D. drugs, therefore, are dependent on whether Pfizer or Rexahn can make "safe" versions of their products, and whether the FDA can be convinced that pharmacists will be good gatekeepers who can screen men for underlying health problems.

According to Jim DiBiasi, a partner at pharmaceutical consultancy 3D Communications, in Hoboken, N.J., and the author of "The FDA Advisory Committee Survival Manual," OTC Viagra is possible but not likely: "From 30,000 feet, I think they have a chance but they're really going to have to do their homework."

Further Reading


Don't plan to buy Viagra over the counter soon

Happy Valentine's! Want some Viagra? British pharmacy tests selling erectile dysfunction drug over the counter

Over-the-counter Viagra bid ends

Pfizer Seeks Non-Prescription Status for Viagra Despite Health Risk Worries

Utrecht University Study Indicates That Rexahn's Zoraxel™ Could Become New-Class of Drug For Treating Sexual Dysfunction


  1. What will happen when Viagra goes generic?
  2. Viagra Without a Prescription? A Pharma Insider Explores OTC Possibilities
  3. Urologist Survey Regarding Erectile Dysfunction and Treatments

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