Regulators Crack Down On Internet Pharmacies

It’s one of the Internet’s dirty but not-so-little or secret success stories and we’re not talking pornography or gambling. When it comes to drugs, you can get just about anything you want -- licit or illicit -- but the Food and Drug Administration has moved against one of the largest purported online operators, Canada Drugs, which the Wall Street Journal reported in July had shipped counterfeit versions of Avastin, Roche Holding’s cancer-fighting drug, to doctors in the U.S.

The Journal investigation found that Canada Drugs and its founder, Kris Thorkelson, operated drug wholesalers, including Montana Health Care Solutions, that sold cancer treatments from India, Turkey and other countries directly to U.S. doctors, who administer the drugs. Canada Drugs has said that it did not know the drugs were fake.

“So far, the Canada Drugs consumer business -- which the [FDA] has always considered illegal—has largely appeared to dodge the fallout,” Christopher Weaver and Jeanne Whalen report. “But, in a Sept. 21 warning letter to the company, the FDA said the website violates federal law by selling foreign versions of erectile-dysfunction medicines Viagra and Levitra, and other unapproved drugs, to American customers,” 



The FDA warning letter specifically  accuses and dozens of websites allegedly under its purview of offering “unapproved and misbranded new drugs for sale” in violation of multiple sections of the FD&C Act and requests it “immediately cease marketing violative drug products to United States consumers.”

The sites were still operating last night. Neither Thorkelson, who was not charged with any offense, nor his attorneys returned emails and phone messages from the Journal reporters requesting comment. 

Meanwhile, an operation code-named Operation Pangaea V, co-ordinated by Interpol and involving 100 countries, has shut down 18,000 online pharmacy sites around the world in the past few days, Andrew Jack reports in Financial Times. Seventy-nine people were arrested and more than of 3.7 million doses of unlicensed and counterfeit drugs worth more than $10.5 million were seized.

As part of the operation, the FDA took action in the U.S. 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 agency says in a release.

“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,” FDA Commissioner Margaret A. Hamburg says in a statement. “This week’s efforts show that strong international enforcement efforts are required to combat this global public health problem.”

“The growth in the criminal sale of medicines -– which puts people at risk by providing them with drugs without medical supervision and which often contain incorrect ingredients at the wrong doses -– reflects modest penalties for offenses versus the high profits that can be made,” Jack writes. 

Investigators say that less than a dozen criminal groups are responsible for the majority of sales, which were dominated by online pharmacies, Evapharmacy and GlavMed. Most of the spam generated by the sites peddled erectile dysfunction drugs but also pushed cancer treatments, antibiotics and antidepressants, according to Jack.

“Because of inconsistent laws, and the international reach and elusive nature of online pharmaceuticals, the proliferation of online drugs has become an international worry that is hard to address,” Eric Palmer writes in Fierce Pharma Manufacturing. “Authorities are trying to block links to the sites and online payment systems.”

According to a Reuters account, the FDA “targeted websites selling potentially dangerous medicines, including those with active ingredients approved by the FDA for use only under the supervision of a licensed health care practitioner or containing active ingredients that had been withdrawn from U.S. markets due to safety issues.”

That list includes to Tamiflu, Viagra, domperidone and isotretinoin, which once was marketed as the acne treatment Accutane but has been linked to birth defects, according to Reuter’s Debra Sherman and Bill Berkrot. The busts are part of the fifth annual International Internet Week of Action –- “a global effort to fight the online sale and distribution of potentially counterfeit and illegal medicine.”

The FDA last week launched BeSafeRx – Know Your Online Pharmacy, a national campaign to raise public awareness about the health risks of using fraudulent Internet pharmacies and what consumers can do to protect themselves. An FDA survey of 6,090 adults who have bought products over the Internet found that 23% reported buying prescription medicine products over the Internet. Fifty-seven percent were women and 87% of all purchasers reported themselves to be in “good” to “excellent” health.

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