FDA gets tough on drug pedigrees
in combating drug counterfeiting by bringing charges against drug
wholesalers for failing to carry out measures designed to safeguard
the pharmaceutical supply chain.
The agency has all but declared war on drug counterfeiters after seeing an alarming rise in the number of fake drugs entering the US market, a trend which seems to be occurring around the world.
Two Ohio-based prescription drug wholesalers have pleaded guilty to charges that they failed to provide to their customers what is commonly referred to in the pharmaceutical industry as a drug 'pedigree' or a 'Statement Identifying Pharmaceutical Sale.' The FDA said it took the action after responding to reports that products distributed by the companies were counterfeit or misbranded.
This is one of the first convictions of its kind and suggests the FDA is more willing to flex its enforcement muscles in ensuring that prescription drug wholesalers fully conform with laws aimed at protecting the US drug supply.
The two companies - RxBazaar and its wholly owned subsidiary, FPP Distribution - each pled guilty to one misdemeanour charge of not providing required documentation identifying each prior sale, purchase, or trade of prescription drugs that they distributed.
Each company was sentenced to five years probation and a $100,000 fine. A second conviction for the same misdemeanour offence is a felony and subject to harsher penalties.
RxBazaar is a publicly traded company that operates a web site called www.rxbazaar.com through which buyers and sellers would conduct wholesale pharmaceutical transactions. It collects fees from sellers and distributes the pharmaceuticals to customers through FPP Distribution.
One of the many provisions of the 1988 Prescription Drug Marketing Act (PDMA) is the requirement for drug wholesalers that are not manufacturers or authorised distributors of a drug to provide a pedigree for every prescription drug they distribute.
"Drug wholesalers that do not provide pedigrees, or provide fraudulent pedigrees, facilitate drug counterfeiters and diverters looking to enter illegal and potentially dangerous products into US commerce," said the FDA in a statement.
