FDA fights Web pharmacies selling unapproved drugs
TRENTON, N.J. (AP) — The Food and Drug Administration is stepping up its fight against counterfeit and other potentially harmful medicine sold over the Internet.
The agency is ordering operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers.
The move is part of a weeklong global crackdown by regulatory bodies and law enforcement on websites selling counterfeit, substandard and unapproved medicines, aimed at making the global medicine supply safer.
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.
"This is a first step," said FDA spokeswoman Sarah Clark-Lynn. "The door isn't closed on these cases."
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 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. None of the companies responded to requests for comment from The Associated Press on Friday. Clark-Lynn said she did not know whether any of the companies had responded to the FDA.
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 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.
Interpol said Thursday that Pangea V resulted in the arrests of about 80 people and the seizure of about 3.7 5 million doses of potentially life-threatening medicines worth $10.5 million. In addition more than 18,000 illegal pharmacy websites were shuttered.
"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," John Roth, director of the FDA's Office of Criminal Investigation, said in a statement.
Besides national health and law enforcement agencies, participants included the World Customs Organization and the Center for Safe Internet Pharmacies, a year-old nonprofit group that includes Internet domain name registries, registrars, shipping companies, payment processors such as PayPal and American Express, and advertising service providers.
Meanwhile the FDA is warning doctors about the dangers of giving patients unapproved, counterfeit and unsafe drugs. In late September, the agency sent letters to doctors in 33 states, saying it had received information that they had purchased medicines from foreign or unlicensed suppliers that sold illegal prescription medicines. FDA directed them to stop administering drugs obtained from those sources.
Linda A. Johnson can be followed http://twitter.com/LindaJ_onPharma