In collaboration with international regulatory and law enforcement agencies, the FDA took legal action against more than 4,100 internet pharmacies via criminal charges, seizure of illegal products, and removal of websites.
This noteworthy bulletin comes directly in the midst of the 5th annual International Week of Action (IIWA), a joint venture to tackle the online sale and distribution of phony and illegal drugs. This year's objective, Operation Pangea V, resulted in the closing of over 18,000 unauthorized pharmacy websites and the confiscation of around $10.5 million worth of pharmaceuticals around the globe. The goal of this effort, involving different officials from 100 countries, was to pinpoint producers and suppliers of illegal medical devices as well as pharmaceutical products and remove them from the market.
FDA Commissioner Margaret A. Hamburg, M.D., says:
"Consumers in the United States and around the world face a real threat from Internet pharmacies that illegally sell potentially substandard, counterfeit, adulterated or otherwise unsafe medicines. This week's efforts show that strong international enforcement efforts are required to combat this global public health problem. The FDA is committed to joining forces to protect consumers from the risks these websites present."
To accompany this international effort, the FDA launched a national campaign to educate Americans about the dangers of purchasing prescription medications online. "BeSafeRX, know your Online Pharmacy", focuses on awareness about the health risks of using illicit pharmacies and how consumers can protect themselves.
The FDA targeted websites who were selling illegal and potentially dangerous medications. These medications could be damaging to the public because many of them contained active ingredients that should only be used under the guidance of a certified healthcare practitioner, or ingredients that have previously been removed from the market due to safety issues.
Illegal medicines that were being distributed included:
- Domperidone: removed from the market in 1988, it can cause severe side effects such as irregular heartbeat, stopping of the heart, or sudden death. These damaging effects could be passed from a breastfeeding mother to a nursing baby, if these women used domperidone to increase milk production, an unapproved use.
- Isotretinoin (Accutane): used to treat intense nodular acne and has extreme risks, such as birth defects if pregnancy occurs while using this medicine. FDA-approved isotretinoin capsules are only available by limited distribution in the U.S.
- Tamiflu: often sold online as "generic tamiflu", there is no FDA-approved version of generic tamiflu, and FDA tests showed versions sold over the internet contained the wrong active ingredient. This ingredient was similar to penicillin and could cause potentially life threatening allergic reactions.
- Viagra: used to treat erectile dysfunction. This particular medicine should not be used by consumers with heart conditions. Taking this medicine without supervision from a healthcare professional, one may not gain the knowledge of side effects, such as the increased blood pressure lowering effects of organic nitrates when taken with sildenafil citrate.
First, the FDA sent letters of warning to the managers of 4,100 recognized websites. Second, the agency sent notices to registries, internet service providers, and domain name registries (DNRs) notifying them that the products for sale on their sites were in breach of U.S. law. Currently, the FDA is working with all involved countries worldwide to address the remaining websites that continue to operate by selling illegal medications to U.S. consumers.
John Roth, director of the FDA's Office of Criminal Investigation, concludes:
"Internet pharmacies that illegally sell unapproved, counterfeit, or potentially adulterated or substandard drugs are an inherently international crime problem. The FDA is pleased to work with INTERPOL, the international police agency, to fight this problem. Because these criminals do not respect international borders, the international coordinated law enforcement response represented by Operation Pangea demonstrates that international cooperation is the best way to protect the American public from the risk of unsafe drugs."
During Operation Pangea V, the FDA screened all drug products that came in through international mail facilities during the IIWA. Findings show products such as antibiotics, antidepressants, and other medications to treat high cholesterol, diabetes, and high blood pressure were on their way to U.S. purchasers. Several of those products were potentially dangerous if taken without the supervision of a health care practitioner, or if the products had previously been removed from the market for safety issues.
Written by Kelly Fitzgerald