There is no doubt that the manufacture and sale of counterfeit medications is on the rise. The number of Food and Drug Administration (FDA) counterfeit drug cases opened between 2004-07 was more than double 2000-03, while the number opened in 2003 was itself five times that opened in 2000. In 2007, FDA counterfeit cases resulted in 71 arrests, 50 convictions and $26.5 million in fines and restitution.
In April 2008 the FDA had 20 open counterfeiting cases from just one of two regional California offices.
It is estimated that 15% of all drugs that are sold are counterfeit, and online this number is certainly higher. Drugs sold from Africa and Asia are counterfeit more than 50% of the time. One study cited by the World Health Organization (WHO) predicts that counterfeit drug sales will reach $75 billion (U.S.) by 2010—a more than 90% increase from sales in 2005.
The FDA defines counterfeit drugs as "drugs sold under a product name without proper authorization," but often counterfeits lack both the proper authorization and proper ingredients. Counterfeit drugs may not contain the active ingredient at all, or may contain an insufficient or excessive quantity of the active ingredient. They even may contain hazardous ingredients.
In 2003, government officials seized batches of counterfeit Procrit (epoetin alfa) – an injectable medication to help cancer, anemia and HIV patients increase their red blood cell count – that contained nothing but bacteria-tainted water. Drug counterfeiters have no scruples with doing whatever it takes to obtain the highest possible return in the shortest possible time period—even if it means killing those who ingest their tainted product.
There are many causes for the increasing prevalence of counterfeit medications. The technology to produce everything from labels to active pharmaceutical ingredients is now widely available. However, some drug counterfeiting facilities resemble the fancy labs of legitimate manufacturers, while others are as filthy and poorly maintained as a public restroom.
Additionally, the regulations governing drug distribution do not provide a sufficiently strong deterrent in terms of enforcement and penalties to discourage counterfeiters. Counterfeiters can afford the risk because drug counterfeiting is difficult to investigate and detect. Much of the product is shipped directly overseas to places such as the U.S.
Indeed, the internet is a principal cause of the surge of drug counterfeiting in recent years. It provides counterfeiters with ready access to consumers and markets, and enables them to sell drugs directly to consumers, without face-to-face contact. Anyone can set up a website, from anywhere in the world. A drug counterfeiter could claim to be based in the U.S. but in fact be located in India, China, Mexico, or Africa, where drug counterfeiting is rampant due in part to a lack of regulations in their respective drug supply chains. FDA-approved medications can be ordered and prescribed safely online, but the consumer must educate themselves and perform the necessary research.
Quality-assurance verification measures help steer conscientious consumers to reputable online pharmacies. Consumers should always check to ensure that they are dealing with a U.S. pharmacy that provides a street address and customer-service phone number. Consumers should call the online facilitator to ask questions and verify that they will receive FDA-approved medications.
Unfortunately, however, with the weak economy and reductions in health benefits, there is a large a consumer "preference" for counterfeit medications. The difference between FDA-approved generic medications (which are safe) and "counterfeit" medications (potentially harmful) should not be confused.
Many illegitimate online pharmacies, most based in countries outside the U.S., provide prescription medications termed "generic" in nature at less than wholesale price, with no prescription necessary. These drugs are not FDA-approved and are potentially harmful. Many of these medications are known as "lifestyle drugs," i.e., medications to treat conditions such as impotence, wrinkles, herpes, acne, obesity, or baldness.
Often people with one of these conditions do not bother to seek medical help in treating it—either because of shame, lack of insurance coverage, or because they do not view their ailment as a legitimate medical condition. Therefore, they may not visit with a physician.
Many of these consumers turn to other channels and knowingly buy non-FDA-approved medications, or buy prescription medications from venues not requiring a prescription. This means that consumers put blind trust in a company and simply hope they receive the legitimate, FDA-approved prescription drug. The FDA strongly encourages consumers not to make this potentially dangerous mistake.
This consumer "preference" or susceptibility to drug counterfeiters is particularly evident in the arena of erectile dysfunction (ED). A "generic medication" Google search of any of the three ED medications—Viagra, Cialis, and Levitra—turns up websites offering "generic" versions of the drugs.
As is typical of generics, these drugs are sold at a fraction of the cost of the patented drugs. But currently there are no FDA-approved generics of any of these medications, as their patents have yet to expire. The average consumer might not even know to investigate whether licensed generics for these drugs are currently on the market.
ED medications are additionally susceptible to consumer abuse, in that some consumers use them as recreational drugs, i.e., to enhance sexual performance rather than to treat impotence. This could lead consumers to cheap, substandard medications, such as counterfeits. As stated earlier, authentic, FDA-approved medications (Viagra, Cialis and Levitra) are the only ED medications considered to be legal/safe for sale in the U.S.
Pfizer in particular has taken aggressive action to curb online sales of counterfeit Viagra. In 2004 the company filed a barrage of lawsuits against online pharmacies found to be selling generic, counterfeit or fake Viagra, accusing them of trademark infringement and dilution and unfair competition under both federal and state law, as well as deceptive trade practices in violation of New York state law.
They seized the domain names of these online pharmacies and teamed up with numerous government organizations including the Department of Justice, the Federal Bureau of Investigation (FBI), U.S. Customs and Border Protection, and the FDA, to crack down on illegitimate online pharmacies.
Pharmaceutical companies have more than a financial stake in quashing the sale and manufacture of counterfeit ED drugs. According to a former executive at one of the companies that manufactures one of the three ED drugs, 30% of patients who use ED drugs use it just one time, or only get one prescription.
One probable reason for this, said the former executive—who asked that he and the company he worked for remain confidential —is that patients subsequently turn to channels of dubious legitimacy where they can purchase the medication at less cost.
This causes a tremendous drop-off in the company’s revenue, obviously, but it also presents a serious problem when a patient who has taken a counterfeit drug goes through the medical system with adverse reactions.
The patient thinks he has taken the legitimate, FDA-approved drug. Pharmaceutical companies generally can detect a counterfeit when medical professionals notify them of adverse reactions that do not fit the profile of known adverse reactions to their drug, and they immediately utilize every available channel to notify the public. Nevertheless, when the public hears word of these adverse reactions, perhaps through consumers who unknowingly took counterfeit ED medication, it threatens the integrity of the patented drug.
The result, says the former executive, is that consumers who perhaps legitimately suffer from ED become confused by the conflicting information they may be hearing. They question the safety and efficacy of the legitimate drug, and then become frightened from visiting their physician and getting the safer medication they need.
According to the former executive, it is already the case that "only one third of patients actually follow their physician’s recommendations when it comes to medication." Pharmaceutical companies, therefore, have a stake in protecting the integrity of their trade name not only to protect their revenue stream, but also to protect consumers: the two goals go hand-in-hand.
Pharmaceutical companies devote significant resources to the investigation and indictment of counterfeiting operations. Much of the resources go to the exploration and implementation of new technologies to deter counterfeiting, such as holograms, color-shifting inks, and other special packaging and printing techniques that make counterfeiting easier to detect. One promising example is the use of Radio Frequency Identification (RFID) chips and taggants, which enable wholesale distributors and pharmacies to confirm that the product only passed through legitimate, licensed entities in the drug supply chain.
In addition to these efforts, pharmaceutical companies also strive to increase cooperation with law enforcement agencies to successfully prosecute counterfeiters. Lastly, the companies devote resources to educate consumers about the dangers of procuring prescription medications through channels that do not require prescriptions – mainly online pharmacies that are not licensed in the U.S.
Consumer who do their homework and find an appropriate U.S.-based pharmacy will be much better served, and be at the least risk to receive harmful or ineffective medications.
"The educated consumer," says the former executive of one ED drug manufacturer "is our best customer."