FDA Warning Letters Target Illegal Online Pharmacies

Nov 24, 2009

As part of an international effort to push back against illegal drug sales, FDA sent 22 warning letters last week to operators of online pharmacies accused of violations of US law. The letters were issued to the operators of sites engaged in the unlawful sale of unapproved or misbranded drugs to US consumers, though none of the Web sites involved belong to US pharmacies.

“The FDA works in close collaboration with our regulatory and law enforcement counterparts in the United States and throughout the world to protect the public,” said FDA Commissioner Margaret Hamburg in a press release. “Many US consumers are being misled in the hope 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 the active ingredient. Taking these drugs can pose a danger to consumers.”

The effort represents FDA’s collaboration in the International Internet Week of Action, a global crackdown involving authorities from 26 countries. The operation, also called Pangaea, included Interpol officers in Europe and task forces around the globe performing raids on suspected counterfeit drug operations.

“It is an excellent step; we know that fraud is widespread and has potential to harm consumers rather widely,” said Fred Felman, chief marketing officer of Mark Monitor, which authors a Brandjacking Index for the pharma industry. “We applaud their efforts.”

FDA alerted Internet service providers and domain registration companies of the violations, giving the providers grounds to take down the offending Web sites. The sites were selling regulated drugs such as Xanax without requiring a prescription, and often offered drugs that had yet to be approved by the FDA. All the sites implicated by FDA can be traced back to Rx-comission.com, a site claiming to belong to a pharmacy affiliate program, according to The Washington Post.

“People who abuse the domain name system are very good at playing a shell game. A one-time effort is a good thing to send a signal to these folks,” said Felman.

Unfortunately for American consumers, FDA’s action fails to address the thousands of other phony pharmacies with tens of thousands of shady sites accessible on the Web. Microsoft search engine Bing was implicated last August by a study that says nine of 10 pharmacy ads on the site violate US law.

Felman believes pharma should encourage Congress to make operations like Pangaea ongoing to better combat illegal online pharmacies. “There are more networks than the one they apparently took down. We receive a lot of websites and a lot of interrelations,” said Felman, whose company is currently tracking over 3,000 illegal pharmacies online.

“The simplest thing is for consumers to deal with reputable online pharmacies. A good place to start is the National Association of Boards of Pharmacy—all other bets are risky.”