Should Viagra Be Available Over the Counter?

Just as globalization has affected many legitimate industries, globalization has had an enormous effect on the counterfeit drug market.

With the saturation of internet availability and web hosts that look the other way when sellers of fake drugs set up websites, a person can set up a website just about anywhere around the world and immediately start selling counterfeit drugs to those who don’t want to visit a doctor or pharmacy. Punishment for selling counterfeit drugs isn’t certain or severe enough to be much of a deterrent, and the worldwide market for fake prescription drugs is now worth around $75 billion per year.

Sometimes these counterfeit drugs cost lives. In 2012, counterfeit versions of a cancer drug called Avastin were distributed in the US, and fake anti-malarial drugs now contribute to nearly half a million preventable deaths each year. Counterfeit versions of the ADHD drug Adderall and of another cancer drug, Altuzan, have been distributed in the US too. As the supply chain for legitimate drugs has lengthened in recent years, every link in the distribution chain provides the opportunity for counterfeiters to cash in.

Erectile dysfunction (ED) drug Viagra is the most counterfeited drug in the world, and more than three-quarters of the Viagra purchased online is believed to be fake. Some people believe that the key to cracking down on counterfeit Viagra is making it readily available without a prescription.

Steps in Allowing Drugs to be Sold Over the Counter (OTC)

For a prescription drug to gain approval to be sold over the counter, the drug must first be approved by the US Food and Drug Administration (FDA) under its traditional New Drug Application (NDA) process. The FDA’s review of OTC drugs is handled by the Center for Drug Evaluation and Research (CDER)’s Office of Drug Evaluation IV. A Nonprescription Drug Advisory Committee meets to help the FDA evaluate issues surrounding these drugs.

The FDA reviews the active ingredients in the drug as well as the labeling, based on the drug’s therapeutic class. Each therapeutic class has what is called an OTC drug monograph, which covers acceptable ingredients, dosages, formulations, and labeling. The monographs define a drug’s safety and effectiveness, and is the standard to which formerly prescription-only drugs are compared before being approved for OTC sales.

Lilly Wants Cialis to Be Sold Over the Counter

In May 2014, Eli Lilly and Co. made headlines when it proposed that its ED drug Cialis be made available over the counter without a prescription. Under the proposed licensing deal between Lilly and French pharmaceutical company Sanofi, the drug would be the first prescription drug in the PDE-5 inhibitor class (which also includes Viagra) for ED made available over the counter. If approved, Cialis OTC could be launched in 2018, the same year patents for Cialis expire in the US and Europe. Making the drug OTC would allow Lilly to hold onto some of the profits it would expect to lose to generic competitors after patent expiration. Currently, Cialis is Lilly’s fourth best-selling drug.

Viagra has managed to hold onto its US patent longer than originally expected due to court rulings favoring the drug’s “method of use” patent that was obtained a few years after the original Viagra patent. Viagra is off-patent in the EU and Canada, but generic competitors in the US won’t be available until late 2017. Should Viagra be made available over the counter too?

Why Selling Viagra Without Prescription Could Be Beneficial

Viagra is so frequently counterfeited that buying it online is a real gamble, unless you’re purchasing it from a source that requires a prescription and complies with all US regulations for dispensing prescription drugs. Were Viagra to be made available on a non-prescription basis, men would have one less reason to purchase it from sketchy online sites, and the flow of fake Viagra could slow considerably. Not only could OTC Viagra slow counterfeit drug trade and offer men a safe option, it would allow Pfizer to develop OTC brand loyalty that could help it hold onto profits from the drug once generic competitors are allowed in the US.

Parallel Arguments to Those for Marijuana Legalization

Another argument can be made for OTC Viagra that parallels an argument for legalization of marijuana in the US: people are going to consume it anyway, and making it legal would allow for better regulation of the product. A letter published in BMJ earlier this year discussed research at sewage treatment plants in the Netherlands indicating that around 60% of sildenafil (the active ingredient in Viagra) could not be explained by prescribing patterns. In other words, around 60% of the drug consumed in the Netherlands was likely procured illegally. Researchers found no indication that large scale dumping of the drug had occurred to produce the levels found in the sewage. They believe that online rogue “pharmacies” are to blame for the illicit Viagra found in the study.

Protect Yourself from the Dangers of Counterfeit Viagra

Millions of men worldwide have taken Viagra that’s prescribed legitimately and have enjoyed relief from ED because of it. However, many men are uncomfortable broaching the topic of ED with their physicians, which is understandable considering ED wasn’t openly discussed at all until about 15 years ago, when Viagra was introduced to the market.

However, unless and until Viagra is sold over the counter, the only way to ensure you’re taking the legitimate product is to obtain it through a legitimate supplier, and suppliers that offer Viagra without a prescription and with no questions asked are not legitimate and are likely to be selling fake product. Fake Viagra may or may not contain sildenafil, and it may or may not contain harmful ingredients. Likewise, sources peddling “natural” or “herbal” Viagra may sell products that contain sildenafil in harmful amounts, so there’s no way to be sure these products are safe either.

eDrugstore.com has sold only genuine Viagra made by Pfizer for over 15 years. eDrugstore.com contracts with US-licensed pharmacists and provides lot information customers can use to verify that the product is real. Taking chances with your health by purchasing “Viagra” through dodgy websites is simply not worth the risk, and you should always be certain you are purchasing the genuine product made by Pfizer.