From PDUFA V to Pangea V.
FDA is ordering operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers.
It also follows the FDA’s launch last Friday of a campaign to warn consumers that the vast majority of online pharmacies do not follow laws or pharmacy industry standards and their products could harm or even kill people. The campaign includes a new website, www.fda.gov/BeSafeRx, that explains the risks of fake online pharmacies and how to tell the difference between those websites and legitimate ones.
The FDA has sent warning letters to three companies behind most of the 4,100 websites it identified as illegally selling potentially dangerous, unapproved drugs. It’s also seized some illegal medicines, filed civil and criminal charges against companies and individuals, and contacted Internet registrars and service providers, asking them to suspend the 4,100 websites.
According to the FDA one business, called CanadaDrugs.com, operates 3,710 of the targeted websites. Another company, identified in the warning letter as Eyal Bar Oz, runs more than 200 sites. A third company, called Arkadiy Kisin/White Forest Solutions, also operates more than 200 sites.
The drugs include various versions of the erectile dysfunction drugs Viagra, Levitra and Cialis, as well as an unapproved contraceptive called Norplant, an unapproved generic version of the influenza treatment Tamiflu, an unapproved antibiotic called Baycip TZ, and a drug for stomach disorders that also increases production of breast milk but is not approved because it’s been linked to irregular heartbeats, cardiac arrest and sudden death.
The warning letters say that the websites have been offering unapproved drugs to U.S. consumers. The letters, sent to the companies between Sept. 18 and 21, order them to reply within 10 business days.
As yet -- no reported replies.
The warning letters to the three companies are part of a simultaneous crackdown on online sellers of counterfeit and illegal medical products, involving police and regulators in 100 countries around the world. The fifth annual campaign coordinated by Interpol, the international police agency, is known as the International Internet Week of Action, and also as Operation Pangea V.
Let's hope that, in the case of Pangea, "V" also stands for "Victory."