Internet International Week of Action Reinforces Anti-counterfeiting Efforts
The Internet International Week of Action (IIWA) resulted in the United States Food and Drug Administration (FDA) issuing twenty–two warning letters to the operators of illegal websites on November 16, 2009. The operation was coordinated by the International Criminal Police Organization (INTERPOL), the World Health Organization’s (WHO) International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and involved law and drug regulatory agencies in 25 countries. This is a significant increase over 2008. Last year, the effort was a day long with 8 countries participating.
The weeklong operation focused on illegal websites by targeting their Internet Service Provider (ISP), payment systems and delivery services. (None of the websites that were investigated had origins in the US or Canada.) Nearly eight hundred websites were identified as marketing illegal or prescription only drugs, with 94 websites being closed down. According to Interpol, 1650 packages were seized and nearly 168,300 pills were confiscated. Types of medications seized included medicines for:
- contraception
- weight loss
- pain relief
- asthma
- local anaesthesia
- steroids
- erectile dysfunction
- hair loss
Illegal marketing of drugs and devices through web sites continues to be a significant safety concern for health authorities around the globe. Seizures were made in the UK, France and South Africa. In the news release about the seizures, FDA Commissioner Margaret Hamburg, M.D. commented “Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies. Unfortunately, these drugs are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of active ingredient. Taking these drugs can pose a danger to consumers.”
Sponsors of these products need to be prepared with an anti-counterfeiting regulatory strategy. Planning anti-counterfeiting efforts is routinely included in our pre-marketing strategy consultations. Some methods currently being used include:
- Specific dyes—inexpensive, easy for the consumer to identify, can be added to individual dose/
- Barcodes—less expensive than RFID. More errors in reading barcodes than RFID.
- Codes—manual trace process, consumer friendly.
- Holograms—inexpensive option, easily identified by consumer,
- Radio Frequency Identification (RFID) – allows tracking of drug from manufacture to pharmacy. Is expensive to implement and maintain. Privacy concerns with implementing beyond the pharmacy level.
- Pedigrees—Provides information on the drug and its route through the supply chain. There is movement to an ePedigree requirement that would provide real time information.
No one strategy will prevent or stop counterfeiting. Each manufacturer will need to evaluate factors, such as cost, likelihood of counterfeiting, market size, etc. to determine the best strategy or strategies for them. Safis has experience in guiding clients through the planning of anti-counterfeiting efforts as part of our Regulatory consultation. Companies that have successfully combated counterfeiting efforts have included their customer service representatives in the process. Often, a customer will contact the company with a question that alerts the representative to the possibility of a counterfeit product.
Counterfeiting continues to be an area of concern. The final results of this investigation are not complete. Additional information about the Internet International Week of Action can be found on the FDA and Interpol websites.