February  2013

 

New Jersey Physician Advisory:   

Be Warned Over the Use of Illegally Imported Prescription Drugs

 

The US Food and Drug Administration is cracking down on physicians who are buying illegally imported drugs and selling them in the United States.  

Illegal prescription drug importation occurs when foreign pharmacies, traders or suppliers ship pharmaceuticals not intended for sale in the United States (and which may or may not have been approved for use in foreign countries) into the United States for use by American consumers.  The importation and counterfeiting of prescription drugs is a growing problem.  In 2000, FDA opened 6 counterfeit drug investigations; in 2004, FDA opened 58. 

In December 2012, the FDA issued letters to over 350 medical practices that they may have received unapproved medications from a foreign supplier that may be counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe.[1]  FDA warned these medical practices to stop purchasing and administering drugs received from foreign or unlicensed suppliers because they were placing patients at risk and violating federal law.  FDA also posted a list of all of the doctors that received the letter.[2]

Some physicians see importation as a cost-saving alternative because some prescription drugs are sold at lower prices in foreign countries due to artificial price controls in those other countries and because the foreign and unlicensed importers do not comply with FDA regulations.  These healthcare practitioners can undercut competitors selling legitimate drugs.  More importantly, the patients who visit these practitioners usually do not realize they are being treated with illegally-imported drugs, nor do they understand the risks associated with such treatment.  

Indeed, the importation of prescription drugs not only is illegal; it also poses significant health risks to consumers.  Imported drugs are often counterfeit, do not contain the same active ingredients, and do not contain the same important instructions and warnings as their U.S. counterparts and/or may be compromised in some way (e.g., due to inadequate storage or shipping). 

For more information, you can read this recent Wall Street Journal article:  http://online.wsj.com/article/SB10001424127887324731304578193990868029934.html.

If you believe you have been sold, or solicited to purchase, illegally imported drugs, you can report this suspected criminal activity to FDA’s Office of Criminal Investigations (OCI) by calling 1-800-551-3989 or visiting the OCI website: http://www.fda.gov/ICECI/criminalInvestigations/default.htm