When you’re fighting for something you believe in sometimes you lose perspective, and that can lead to overreaction and self-righteous indignation. I’ve been very critical of the FDA because I believe the agency is not doing right by Americans consumers on the issue of online pharmacies and personal drug importation. FDA seems incapable of admitting that there are safe international online pharmacies that help Americans afford medication, and its BeSafeRx program is right out of the big pharma playbook; and…wait, wait, there I go again…
The FDA, specifically its Office of Criminal Investigations, expends a lot of time and energy tracking down people who are intentionally selling fake, expired, or otherwise clearly dangerous pharmaceuticals. Those efforts save lives and ought to instill fear in those perpetrating these acts or those considering doing so. We should and do applaud FDA for those efforts.
I’ve looked at the FDA’s ‘Most Wanted List’ and some of their targets seem to be seriously bad characters. For example, one fugitive, Dushyant Mahendrabhai Patel, was found to have falsified manufacturing and testing data relating to the sterility of a certain medical device. “Specifically, they falsely certified that sterility testing was completed indicating the products sold were safe and effective… These products ultimately caused directly or indirectly at least five deaths and the hospitalization of hundreds of other patients because the products triggered an outbreak of bacterial infections.”
About a decade ago, there was a wave of counterfeit Lipitor being sold by U.S. pharmacies, both online and bricks-and-mortar, such as CVS and Rite Aid. FDA lists a fugitive that may have something to do with this. Pablo Manuel Fernandez is accused by FDA of importing genuine Lipitor mixed in with counterfeit Lipitor. In this case, it appears that Fernandez actually manufactured fake Lipitor in Costa Rica. The result was probably thousands of Americans taking medicine that was supposed reduce cholesterol but it did not work. As it happens, “Fernandez has a 1995 federal conviction for cocaine trafficking. He received a prison sentence of 85 months.”
We often bemoan with great passion our frustration with the conflation of personal drug importation via verified online pharmacies with the distribution, online and off, of counterfeit drugs. Well, here’s an example of what appears to be one fugitive who purposefully imported counterfeit drugs, which were marketed and sold on the Internet. FDA writes: “Abigail Bridgmon and others used counterfeit markings to sell counterfeit pharmaceuticals over the Internet, including pills that appeared to be OxyContin, Cialis, Viagra, Levitra, Valium, and human growth hormones…[they] recruited individuals as drop shippers to help distribute the counterfeit pharmaceutical drugs throughout the U.S. to customers who ordered the drugs over the Internet.”
The FDA, in concert with other law enforcement agencies, investigates, apprehends and prosecutes people who have intentionally manufactured and/or distributed counterfeit, expired, and otherwise bad medicine, such as the people identified above. While there’s no need to conflate such scary practices with the safe personal drug importation of genuine medication pursuant to a valid prescription ordered online, let’s not lose site of the good work done by FDA in protecting the public health.Tagged with: Enforcement, OCI, Office of Criminal Investigations, public health