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A Growing Problem Worldwide
Counterfeit drugs are defined by the US Food and Drug Administration (FDA) as drugs that are sold under a product name without proper authorization. Counterfeiting means that a product is labeled in a way that suggests it’s the authentic, approved product made by the genuine manufacturer, when it’s really not. Counterfeits can be made for both brand-name drugs and generic drugs.
Counterfeiting is difficult to detect, investigate, and quantify. As a result, the full extent of the problem is unknown. However, the FDA estimates that more than 10% of drugs worldwide are counterfeit. In some countries, the counterfeit drug supply is as high as 50%.
There are many factors that contribute to the growth of counterfeiting, including:
- Sophisticated tools that can copy genuine pharmaceutical packaging
- The high value of some products, even in small quantities, which makes it profitable to counterfeit them
- High demand for some drugs—in some cases, the supply is restricted, while in other cases, they may have an illicit off-label use (for example, steroids may attract counterfeiters due to the economic incentive)
- The ability of counterfeiters to sell drugs directly to consumers over the Internet—when this happens, consumers don’t know they’re buying counterfeit products
- Criminal penalties that are too low to discourage counterfeiters—currently, the penalty for this crime in the US is only a few years in prison
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Recent reports reveal that in Africa more than 50% of antimalarial drugs are thought to be counterfeit. It is also believed that up to 30% of drugs in Southeast Asia and China may be counterfeit.
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What qualifies as counterfeit?
Counterfeit products may include medicines that:
- Contain the wrong ingredients or improper doses of the correct ingredients
- Contain inactive substances that don’t provide any benefit to patients, instead of active ingredients
- Contain harmful ingredients
- Communicate incorrect patient information, which could result in misuse
- Are expired products
- Have not been manufactured, packaged, or stored under properly controlled conditions, as required by FDA regulations
- Have been manufactured in foreign countries that do not have the same regulatory safeguards as those required in the US by the FDA
It’s easy to see that counterfeit drugs pose many potential hazards to patients. Learn more about the impact of counterfeit drugs.
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