Buyer Beware: FDA Issues Warning Related to H1N1 Drugs Purchased Online

By: Jeff Blake, CIS Senior Compliance Associate
jeffblake@cis-partners.com

It is estimated that approximately 1.7 billion people worldwide use the internet on a daily basis. [1] Further, it has been reported that 85% of these users have purchased goods and services online at one time or another. [1] Needless to say, the internet has drastically changed the way we shop, and has allowed for the creation of countless web sites that enable consumers to purchase goods and services online.

In the United States and Canada, one of the most controversial aspects of the online marketplace is the sale of prescription drugs over the internet. Online pharmacies allow individuals to purchase drugs from the comfort of their own homes, at rates that are more affordable than those available at a traditional pharmacy. In some cases, prescription drugs can be purchased on the internet without a valid prescription from a licensed physician. Thus, individuals without health insurance are purchasing the medicine they need at a fraction of the price being charged by retail pharmacies. Despite these apparent benefits, the U.S. Food and Drug Administration warns that consumers must use extreme caution when purchasing medications online. In their Consumer Safety Guide, the FDA states:

Some Web sites that sell medicine:

• aren’t U.S. state-licensed pharmacies or aren’t pharmacies at all
• may give a diagnosis that is not correct and sell medicine that is not right for you or your condition
• won’t protect your personal information [2]

Some medicines sold online:

• are fake (counterfeit or “copycat” medicines)
• are too strong or too weak
• have dangerous ingredients
• have expired (are out-of-date)
• aren’t FDA-approved (haven't been checked for safety and effectiveness)
• aren’t made using safe standards
• aren’t safe to use with other medicine or products you use
• aren’t labeled, stored, or shipped correctly [2]

Currently, one of the hot topics of discussion in the pharmaceutical industry is the worldwide spread of the H1N1 influenza virus, commonly known as Swine Flu. To date, the FDA has approved two medications for the treatment of this virus: Tamiflu and Relenza. In October 2009, the FDA issued an official warning to urge consumers to be cautious when purchasing these products over the Internet. The warning came as a result of the FDA’s purchase, and subsequent analysis, of several Tamiflu products over the internet. According to the FDA, one such Tamiflu product:

“arrived in an unmarked envelope with a postmark from India and consisted of
unlabeled, white tablets taped between two pieces of paper. When analyzed by the
FDA, the tablets were found to contain talc and acetaminophen, but none of the
active ingredient oseltamivir.” [3]

Without the active ingredient, the medicine will not alleviate the symptoms caused by the H1N1 virus and; therefore, is not a viable treatment option to stop the spread of the virus. Furthermore, consumers can’t be certain of the ingredients contained in the online drugs, which may lead to undesirable side effects or, even worse, death. Margaret A. Hamburg, M.D., FDA Commissioner, stated:

“Products that are offered for sale online with claims to diagnose, prevent,
mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully
evaluated. Medicines purchased from Web sites operating outside the law
put consumers at increased risk due to a higher potential that the products will
be counterfeit, impure, contaminated, or have too little or too much of the
active ingredient.” [3]

The FDA urges consumers to purchase medications, including those to treat H1N1, from safe web sites that are located in the United States and are licensed by the applicable state Board of Pharmacy. The message is clear. If you are going to purchase drugs online, be sure to use extreme caution to protect yourself and your family.

Sources:
[1] http://www.internetworldstats.com/
[2] http://www.fda.gov/Drugs/ResourcesForYou/ucm080588.htm
[3] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186861.htm