Friday, February 15, 2013

IOM Suggests Other Alternatives To The Word "Counterfeit" re: Drugs

FDA Law Blog: Don’t Call It a Counterfeit, and Other Recommendations from the IOM Report on Falsified and Substandard Drugs:

"IOM recommended excluding the use of the term “counterfeit.”  There is disagreement in the international regulatory community as to whether “counterfeit” refers broadly to something that is “not what it claims to be,” or whether the narrower, legal definition, which focuses on trademark infringement, is applicable.  The IOM report forgoes the use of the term “counterfeit,” and instead encourages the use of the terms “substandard,” “falsified,” and “unregistered.”  “Substandard” drugs are “those that do not meet the specifications given in the accepted pharmacopeia or in the manufacturer’s dossier.” "

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