This blog is written by Mr. Steven C. Schurr, Esq. and focuses on health care law matters that pertain to food and drug law, regulatory compliance, privacy rights, insurance coverage, state and federal disability coverage, patient advocacy issues, and mental health coverage and treatment.

Monday, January 16, 2017

Is it Safe to Use Imported Drugs from Canada?

The Senate recently voted against an Amendment that would have allowed " the importation of safe and affordable prescription drugs by American pharmacists, wholesalers, and individuals with a valid prescription from a provider licensed to practice in the United States".  The amendment was proposed because the same, exact chemical medications purchased from outside the country can be far less expensive than their identical counterparts sold in the US.  In many instances, the comparative drugs are even made at the same FDA-approved facility, which may or may not be in the United States. 

While this Amendment sounds like a good idea and sounds very simple (we all know that pharmaceutical prices are way too high in the US), it is not that straightforward to guarantee that medications you may purchase from a Canadian pharmacy, for example, are exactly the same, just as safe, and just as effective, as their US-purchased counterparts.  In addition, even if they are, there are certain legal issues that arise.  Just because you purchase a medication from a Canadian pharmacy, that does not guarantee that the drug is authentic or of the same quality as its US-purchased counterpart.  Such  imported drugs that appear to be from Canada may actually have been manufactured in places like India or Turkey.  There have been instances where individuals have been criminally convicted for importing drugs into the US, including cancer drugs, that have been counterfeit and/or dangerous in their own right. 

Furthermore, even if an imported drug is chemically identical to its US counterpart, the imported drug's product labeling, which includes directions for use and important warnings about side effects, would be different from the current product labeling that is approved for use by the FDA.  Such labeling may not even be in the same language, may not even be readable to the US purchaser, and may not include the FDA's latest warnings or instructions. 

Finally, even if the US-sold and the imported drug are chemically the same, yet the labelling of the imported drug is not the FDA-approved version, the imported drug is considered "misbranded" under US drug law, which means its importation is technically illegal, except for very narrow exceptions.  To ensure these imported medications are "safe" is not that easy, and to declare their importation as legal, is not that simple.

No comments: