FDA PSA on Counterfeit Drugs
Over the past week authorities representing 100 countries engaged in a coordinated global crackdown on illegal pharmaceutical sales via the Internet. This marks the fifth year that Operation Pangea has been run, and according to Interpol, thousands of illegal websites have been targeted.
The concerns – aside from people obtaining potentially dangerous prescription medications without a doctor’s prescription – are that many of the drugs being sold are either counterfeit, of substandard quality, or not approved for sale in some countries.
Counterfeit medicine is now a truly global phenomenon, and all countries of the world are affected as source, transit or destination points.
The World Health Organization (WHO) estimates that up to 1 per cent of medicines available in the developed world are likely to be counterfeit. This figure rises to 10 per cent globally, but in some areas of Asia, Africa and Latin America counterfeit goods can form up to 30 per cent of the market.
Counterfeiting applies not only to 'lifestyle' medicines, including erectile dysfunction and weight loss medicines, but also to 'lifesaving medicines' including those used to treat cancer, heart disease and other serious illnesses.
And it's not just medicines. Fake medical devices also pose a risk. The term 'medical device' covers a wide range of healthcare products from contact lenses to condoms; syringes to surgical instruments; and wheelchairs to radiotherapy machines.
Interpol’s website summarizes this year’s Operation Pangea:
Combating the sale of illegal medicines online
Operation Pangea is an international week of action tackling the online sale of counterfeit and illicit medicines and highlighting the dangers of buying medicines online. Coordinated by INTERPOL, the annual operation brings together customs, health regulators, national police and the private sector from countries around the world.
Activities target the three principal components used by illegal websites to conduct their trade – the Internet Service Provider (ISP), payment systems and the delivery service.
The operation has gained significant momentum since its launch in 2008. The first phase of the operation brought together 10 countries, with the number rising to 100 in 2012.
Dates: 25 September – 2 October 2012
Participating countries: 100 in total
- 3.75 million illicit and counterfeit pills confiscated;
- Estimated value: USD 10.5 million;
- More than 18,000 websites shut down;
- Some 133,000 packages inspected by regulators and customs authorities, of which around 6,700 were confiscated;
- Some 80 individuals are currently under investigation or under arrest for a range of offences, including operating a clandestine laboratory producing counterfeit medicines; membership of a criminal group selling illicit medicine online; and operating websites selling illicit medicines.
The FDA has a press release outlining their involvement in this crackdown, that lists some of the counterfeit drugs that have been seized.
FDA NEWS RELEASE
For Immediate Release: Oct. 4, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
Agency participates in international Operation Pangea V to protect consumers from potentially dangerous, unapproved drugs
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.
The announcement takes place during the 5th annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. This year’s effort – Operation Pangea V – operated between Sept. 25 and Oct. 2 and resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of about $10.5 million worth of pharmaceuticals worldwide.
The goal of this annual effort, which involved law enforcement, customs and regulatory authorities from 100 countries, is to identify producers and distributors of illegal pharmaceutical products and medical devices and remove these products from the supply chain.
“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,” said FDA Commissioner Margaret A. Hamburg, M.D. “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.”
Last week, the FDA reinforced its online efforts with the launch of a national campaign to educate Americans about the risks of buying prescription medications over the Internet. BeSafeRx – Know Your Online Pharmacy seeks to raise public awareness about the health risks of using fraudulent Internet pharmacies and what consumers can do to protect themselves.
During Operation Pangea V, the FDA targeted websites selling unapproved and potentially dangerous medicines. In many cases, the medicines can be detrimental to public health because they contain active ingredients that are approved by FDA for use only under the supervision of a licensed health care practitioner or active ingredients that were previously withdrawn from U.S. market due to safety issues.
Of course, there are legitimate online pharmacies, where you actually get what you paid for. The FDA is promoting a BeSafeRX program to help consumers determine if an online pharmacy is legit.
And finally, the USFoodandDrugAdmin’s Youtube channel recently posted the following video.