Although the first cases of counterfeiting date back to the 2nd Century BC, the earliest actions taken against counterfeit drugs in the United States date back to the 19th Century. In 1848, Congress passed the Drug Importation Act, due to concerns over high casualties caused by adulterated drug supplies provided to the Army during the Mexican-American War. The legislation was the first federal drug law, tightening customs controls to better regulate the entry of medicine imports.
The rapid spread of modern counterfeit drugs can be traced to around 2000. The rise of the Internet created incentives for the mass production and distribution of counterfeit drugs in areas where regulatory capacity is limited. The high profitability of counterfeit drugs has resulted in the dramatic growth of illegal online pharmacies. According to the Alliance for Safe Online Pharmacies (ASOP Global), of the 35,000 active online drug sellers, 96 percent do not comply with applicable laws and pharmacy practice standards.
To avoid falling victim to the dangers of counterfeit medications, consumers need to know what red flags to look for when shopping for medications online. Online pharmacies offer convenience, cheap prices, and privacy, providing an attractive option for consumers—especially those who feel a stigma associated with certain conditions.
Counterfeit drug distributors take advantage of these factors—as well as of a lack of regulation in the market and a shortage of certain types of drugs, such as vaccines during epidemics—to appeal to certain types of consumers. The most common drugs for which consumers seek online pharmacies are:
- weight loss
- erectile dysfunction
- cancer drugs
- cardiovascular disease medications
- medications for chronic illnesses (for example, HIV, diabetes, and Alzheimer’s)
- psychiatric medications
In 2012, a retailer of counterfeit versions of the cancer drug Avastin was able to infiltrate the U.S. supply chain when doctors and purchasing managers inadvertently bought the counterfeit drugs to be administered within their clinics. The counterfeit Avastin lacked the active ingredients needed to fight tumor growth, making it worthless for patients. The only version of Avastin approved by the FDA is manufactured in the United States. The counterfeit Avastin was traced back to a small pharmaceutical company that was operating out of Barbados. This incident helped shed light on the misconception that counterfeit drugs are only a factor for lifestyle drugs, like those marketed for weight loss or erectile dysfunction.
For more than a decade, the United States has participated in INTERPOL’s Operation Pangea, a world-wide effort to fight counterfeits and educate consumers about the dangers of buying medicines online. Each year, the effort brings together customs, health regulators, national police, and the private sector from countries around the world.
In 2018, Operation Pangea XI resulted in:
- 859 arrests worldwide
- Shutting down 3,671 web properties, including websites, social media pages, and online marketplaces
- Seizure of 500 tons of unlawful and counterfeit medicines, including anti-inflammatory medication, painkillers, erectile dysfunction medication, hypnotic and sedative drugs, anabolic steroids, weight loss pills, and medicines to treat HIV, Parkinson’s, and diabetes.
To protect themselves from counterfeit drugs, consumers need to be vigilant:
Do not purchase medicines from illegal online pharmacies.
Do not share or accept a drug from a friend or acquaintance. Only use medication you have obtained from a reputable source such as your doctor or a licensed pharmacy.
Ask your health provider questions about the source of any physician-administered drug prescribed for you.
For infographic: 96% of the 35,000 active online pharmacies are illegal
Add an “Additional Resources” Section
- FDA’s BeSafeRx: Know Your Online Pharmacy – BeSafeRx is a national campaign to raise awareness of the dangers of buying prescription medicines from fake online pharmacies.
- Add additional resources here