FDA Takes On Internet Drug Market | JETLaw: Vanderbilt Journal of ...

Anyone who has listened to any debate on Obamacare or health care reform over the last four years and beyond, knows that the cost of drugs is an important issue to many Americans needing treatment for various illnesses. For those people wishing to purchase drugs without health insurance, and even for those with insurance, drugs can be very expensive. For example, Plavix, an anti-platelet drug used by many to prevent strokes and heart attacks can cost about $6 per pill, or $2000 per year, which pales in comparison to some other drugs. If you were suffering from the rare blood disorder,?paroxysmal nocturnal hemoglobinuria and needed a Soliris prescription, you could end up paying about $409,500 per year.

With the exorbitant costs of some of these drugs it is no surprise that a ?discount? drug market has developed online. In the same way that you could purchase discounted Ray-Bans and Louis Vuitton handbags online, it is now possible to purchase discount pharmaceuticals. Unsurprisingly, the online market for drugs is not that different from the online market for sunglasses and handbags; it is saturated with fraudulent dealers and products. Unlike the online market for sunglasses and handbags, the consequences of purchasing from a fraudulent online drugstore can be grave. When you purchase a knock-off pair of sunglasses, the worst that can happen is that your fashion credibility takes a hit; a counterfeit drug purchase could result in physical harm, or even death.

This past week, the U.S. Food and Drug Administration, in conjunction with many international law enforcement agencies like INTERPOL, cracked-down on the internet drug market. It was part of an annual week-long initiative to prevent counterfeit and illegal drugs from reaching the hands of American consumers. Operation Pangea V resulted in the seizure of $10.5 Million worth of drugs and the shutdown of 18,000 illegal online pharmacies. Some of the main drugs that were targeted included?Domperidone,?Isotretinoin,?Tamiflu, and?Viagra. Websites like?CanadaDrugs.com, which operates 3,710 targeted websites and a company called Eyal Bar Oz, which runs 200 websites, were sent warning letters advising them to stop the sale of illegal drugs to consumers.

In addition to sending warning letters to illegal drug websites the FDA contacted domain registrars to notify them that these websites were violating U.S. laws. This is similar to the U.S. government?s action taken against other online lawbreakers like gambling websites and sports streaming websites.

This raises a variety of legal issues and policy issues for lawyers and lawmakers. Should there be an online market for drugs and if so how can it be better regulated? Should the U.S. simply move to a buyer beware drug policy and focus on patient awareness of the risks associated with online drug purchases? Can the price of drugs be lowered to a point where consumers are not willing to risk buying counterfeit drugs??Criminals will always be one step ahead of the justice system; in the same way that online sports streaming continues to repopulate the internet after a government takedown, online pharmacies will do the same. Is there a better way of policing these websites than an annual sweep of the internet? Could the government institute a legal framework similar to the Digital Millenium Copyright Act, which provides for takedowns of copyright infringing online content; protecting the rights of both copyright holders and internet businesses? Undoubtedly, these questions will continue to be asked and answered as long as the healthcare debate rages on in Washington.

?Raymond Rufat

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Source: http://www.jetlaw.org/?p=13130

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